Multiple Sclerosis
CNS 8 original drugsCNS indication. Multiple Sclerosis has 8 FDA-approved novel treatments, led by Biogen, with 185 active industry clinical trials across 17 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.
Multiple Sclerosis Market Leaders
Companies with the most FDA-approved novel Multiple Sclerosis drugs.
Phase 3 Readouts Pro
12 active Phase 3 trials with confidence-graded completion dates.
Unlock 9 more readouts with confidence-graded estimates
Upgrade to Pro Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.
Multiple Sclerosis Treatments by Mechanism
Top 12 mechanisms across 104 industry trials with a known mechanism of action.
CD20-directed Cytolytic Antibody
31 trials 11 active 2 sponsors
Kinase Inhibitor
3 trials 2 active 2 sponsors
Interferon beta
12 trials 1 active 5 sponsors
Nicotinic acid receptor/Nrf2
25 trials 2 sponsors
Integrin Receptor Antagonist
11 trials 1 sponsor
Pyrimidine Synthesis Inhibitor
9 trials 3 sponsors
Sphingosine 1-phosphate Receptor Modulator
4 trials 2 sponsors
Purine Antimetabolite
4 trials 2 sponsors
CD52-directed Cytolytic Antibody
2 trials 2 sponsors
Muscarinic receptor
1 trials 1 sponsor
Benzodiazepine
1 trials 1 sponsor
Acetylcholine Release Inhibitor
1 trials 1 sponsor
MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.
Multiple Sclerosis Clinical Pipeline by Phase
478 industry-sponsored trials across 118 sponsors
Showing 92 of 92 trials
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | RECRUITING | 2027-03-12 | NCT07483450 |
| Novartis | Fingolimod | — | RECRUITING | 2027-09-30 | NCT04480853 |
| Novartis | — | — | RECRUITING | 2028-11-30 | NCT06733922 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2027-04-13 | NCT05090371 |
| Bristol-Myers Squibb | BMS-986374 | — | ACTIVE NOT RECRUITING | 2028-12-29 | NCT06396039 |
| Novartis | Ofatunumab | — | ACTIVE NOT RECRUITING | 2026-05-18 | NCT06444113 |
| Qilu Pharmaceutical (Hainan) Co., Ltd. | Dimethyl Fumarate Enteric-coated Capsules | — | NOT YET RECRUITING | 2028-04 | NCT07138833 |
| Roche | OCR SC | — | NOT YET RECRUITING | 2029-02-28 | NCT07609719 |
| Biogen | Dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2025-03-27 | NCT05658484 |
| Novartis | Fingolimod 0.5mg | — | COMPLETED | 2025-03-25 | NCT04667949 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2025-02-13 | NCT05199571 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2025-02-04 | NCT05084638 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2024-04-08 | NCT04998812 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2024-03-29 | NCT04998851 |
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Mavenclad® | — | COMPLETED | 2023-09-21 | NCT04783935 |
| Novartis | Quadrivalent influenza vaccine | — | COMPLETED | 2023-07-06 | NCT04667117 |
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Mavenclad® | — | COMPLETED | 2023-06-20 | NCT04776213 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2022-12-15 | NCT04377555 |
| Sanofi | TERIFLUNOMIDE HMR1726 | — | COMPLETED | 2022-05-13 | NCT03856619 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2022-05-10 | NCT04869358 |
| Merck KGaA, Darmstadt, Germany | Mavenclad® | — | COMPLETED | 2021-11-12 | NCT03369665 |
| Novartis | BAF312 | — | COMPLETED | 2021-09-06 | NCT04792567 |
| Sanofi | TERIFLUNOMIDE | Pyrimidine Synthesis Inhibitor [EPC] | COMPLETED | 2021-07-12 | NCT04410965 |
| EMD Serono Research & Development Institute, Inc. | — | — | COMPLETED | 2021-02-27 | NCT03961204 |
| Roche | Ocrelizumab 300 mg | — | COMPLETED | 2021-02-15 | NCT03589105 |
| Biogen | peginterferon beta-1a | Interferon beta [EPC] | COMPLETED | 2020-10-26 | NCT03177083 |
| Genzyme, a Sanofi Company | alemtuzumab GZ402673 | — | COMPLETED | 2020-07-15 | NCT02255656 |
| Merck KGaA, Darmstadt, Germany | Mavenclad® | — | COMPLETED | 2020-05-05 | NCT03364036 |
| Novartis | Fingolimod | — | COMPLETED | 2020-01-24 | NCT02232061 |
| Genzyme, a Sanofi Company | — | — | COMPLETED | 2019-12-11 | NCT03784898 |
| Novartis | Fingolimod | — | COMPLETED | 2019-03-05 | NCT03257358 |
| Novartis | Fingolimod | — | COMPLETED | 2019-02-18 | NCT01705236 |
| Bayer | — | — | COMPLETED | 2018-05-24 | NCT03269175 |
| Biogen | — | — | COMPLETED | 2018-01-27 | NCT03091569 |
| Biogen | peginterferon beta-1a | Interferon beta [EPC] | COMPLETED | 2017-10-02 | NCT02587065 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2017-06-12 | NCT02471560 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2017-02-16 | NCT02410278 |
| Novartis | Fingolimod 0.5 mg | — | COMPLETED | 2017-01-18 | NCT02373098 |
| Teva Branded Pharmaceutical Products R&D, Inc. | Copaxone® | — | COMPLETED | 2017-01-10 | NCT02499900 |
| Novartis | FTY720 | — | COMPLETED | 2016-12-12 | NCT01585298 |
| Novartis | fingolimod | — | COMPLETED | 2016-11-14 | NCT02720107 |
| Merck KGaA, Darmstadt, Germany | Rebif | Interferon beta [EPC] | COMPLETED | 2016-08-20 | NCT02254304 |
| Merck KGaA, Darmstadt, Germany | Rebif® | — | COMPLETED | 2016-04-30 | NCT02064816 |
| Genzyme, a Sanofi Company | Alemtuzumab GZ402673 | — | COMPLETED | 2016-04 | NCT02205489 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2016-03-31 | NCT01930708 |
| Merck KGaA, Darmstadt, Germany | Rebif® | — | COMPLETED | 2016-02-29 | NCT01791244 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2016-02 | NCT02125604 |
| EMD Serono | — | — | COMPLETED | 2016-01 | NCT02019550 |
| Novartis | Fingolimod (FTY720) | — | COMPLETED | 2015-12-26 | NCT01498887 |
| Novartis | — | — | COMPLETED | 2015-12 | NCT02307838 |
| Sanofi | Teriflunomide | Pyrimidine Synthesis Inhibitor [EPC] | COMPLETED | 2015-11 | NCT01895335 |
| Novartis | Fingolimod | — | COMPLETED | 2015-09 | NCT01333501 |
| Novartis | Fingolimod | — | COMPLETED | 2015-07-13 | NCT01623596 |
| Novartis | Fingolimod | — | COMPLETED | 2015-04 | NCT01578330 |
| AbbVie | — | — | COMPLETED | 2015-03 | NCT01930799 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2015-02 | NCT02090413 |
| Novartis | Fingolimod | — | COMPLETED | 2014-06 | NCT01317004 |
| Bayer | — | — | COMPLETED | 2014-04 | NCT01795872 |
| Biogen | BG00002 | — | COMPLETED | 2013-12 | NCT02142205 |
| Biogen | BG00012 (DMF) | — | COMPLETED | 2013-11 | NCT01873417 |
| Biogen | Fampridine | — | COMPLETED | 2013-07 | NCT01480076 |
| Novartis | fingolimod | — | COMPLETED | 2013-06 | NCT01420055 |
| Novartis | Fingolimod | — | COMPLETED | 2013-06 | NCT01534182 |
| Jazz Pharmaceuticals | Sativex | — | COMPLETED | 2013-05 | NCT01964547 |
| Novartis | Fingolimod | — | COMPLETED | 2012-08 | NCT01216072 |
| Biogen | BG00002 (natalizumab) | — | COMPLETED | 2012-07 | NCT00871780 |
| Novartis | Fingolimod | — | COMPLETED | 2012-07 | NCT01310166 |
| EMD Serono | Rebif | Interferon beta [EPC] | COMPLETED | 2012-02-29 | NCT01085318 |
| Biogen | — | — | COMPLETED | 2011-10 | NCT01556685 |
| Astellas | Solifenacin Succinate | Muscarinic receptor | COMPLETED | 2011-01-28 | NCT00629642 |
| EMD Serono | — | — | COMPLETED | 2010-11 | NCT01034579 |
| Biogen | BG00002 (natalizumab) | — | COMPLETED | 2009-11 | NCT00536120 |
| Biogen | Natalizumab | Integrin Receptor Antagonist [EPC] | COMPLETED | 2008-12 | NCT00744679 |
| Biogen | Natalizumab | Integrin Receptor Antagonist [EPC] | TERMINATED | 2023-10-09 | NCT05532163 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | TERMINATED | 2023-04-14 | NCT04878211 |
| Mallinckrodt ARD LLC | Acthar Gel | — | TERMINATED | 2020-07-14 | NCT03126760 |
| Biogen | natalizumab | Integrin Receptor Antagonist [EPC] | TERMINATED | 2016-05-18 | NCT02342704 |
| Biogen | natalizumab | Integrin Receptor Antagonist [EPC] | TERMINATED | 2016-05-02 | NCT02241785 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | TERMINATED | 2016-04-15 | NCT02343159 |
| EMD Serono | Rebif® | — | TERMINATED | 2015-04 | NCT02117050 |
| Novartis | — | — | TERMINATED | 2014-07 | NCT01490840 |
| Novartis | Venlafaxine | — | TERMINATED | 2013-09 | NCT01436643 |
| Novartis | Rivastigmine transdermal patch | — | TERMINATED | 2011-01 | NCT00881205 |
| Bayer | Interferon beta-1b, FRP within 15 days after randomization | — | TERMINATED | 2009-09 | NCT00780455 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | WITHDRAWN | 2025-01-31 | NCT05208840 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | WITHDRAWN | 2019-07 | NCT02472938 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | WITHDRAWN | 2017-10 | NCT02090348 |
| Biogen | Interferon Beta | — | WITHDRAWN | 2017-02 | NCT02234869 |
| Biogen | peginterferon beta-1a | Interferon beta [EPC] | WITHDRAWN | 2016-08 | NCT02568111 |
| Novartis | Fingolimod | — | WITHDRAWN | 2014-06 | NCT01621269 |
| Novartis | — | — | WITHDRAWN | 2013-07 | NCT01709812 |
| Biogen | TYSABRI and AVONEX | — | WITHDRAWN | 2009-08-01 | NCT00771043 |
Showing 100 of 171 trials (top 100 by completion date — export for full list)
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Celltrion | CT-P53 | — | RECRUITING | 2027-02 | NCT05906992 |
| Sanofi | Frexalimab | — | RECRUITING | 2027-07-15 | NCT07325292 |
| TG Therapeutics, Inc. | Ublituximab | — | RECRUITING | 2027-12-01 | NCT05877963 |
| Biocad | BCD-281 | — | RECRUITING | 2028-12 | NCT07321093 |
| Novartis | Remibrutinib oral treatment | — | RECRUITING | 2029-07-24 | NCT06846281 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | RECRUITING | 2029-12-31 | NCT06675955 |
| Zenas BioPharma (USA), LLC | Orelabrutinib | — | RECRUITING | 2030-06 | NCT07299019 |
| Zenas BioPharma (USA), LLC | Orelabrutinib | — | RECRUITING | 2030-06 | NCT07067463 |
| Novartis | Remibrutinib (blinded) | — | RECRUITING | 2030-12-03 | NCT07225504 |
| Bristol-Myers Squibb | Ozanimod | — | RECRUITING | 2031-04-11 | NCT06408259 |
| Novartis | Remibrutinib | Kinase Inhibitor [EPC] | ACTIVE NOT RECRUITING | 2026-07-23 | NCT05156281 |
| Novartis | Remibrutinib | Kinase Inhibitor [EPC] | ACTIVE NOT RECRUITING | 2026-07-23 | NCT05147220 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2026-10-22 | NCT03523858 |
| TG Therapeutics, Inc. | Ublituximab | — | ACTIVE NOT RECRUITING | 2026-10-31 | NCT07211633 |
| Novartis | CYB704 | — | ACTIVE NOT RECRUITING | 2026-11 | NCT06847724 |
| Immunic AG | IMU-838 tablets | — | ACTIVE NOT RECRUITING | 2026-11 | NCT05134441 |
| Immunic AG | IMU-838 tablets | — | ACTIVE NOT RECRUITING | 2026-11 | NCT05201638 |
| Amgen | Ocrelizumab (US) | — | ACTIVE NOT RECRUITING | 2027-01-15 | NCT06700343 |
| Sanofi | Frexalimab | — | ACTIVE NOT RECRUITING | 2027-05-06 | NCT06141473 |
| Biogen | BIIB017 (peginterferon beta-1a) | — | ACTIVE NOT RECRUITING | 2027-05-20 | NCT03958877 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2027-12-31 | NCT05269004 |
| Sanofi | Frexalimab | — | ACTIVE NOT RECRUITING | 2028-03-24 | NCT06141486 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2028-09-30 | NCT03650114 |
| Sanofi | Tolebrutinib | — | ACTIVE NOT RECRUITING | 2029-04-30 | NCT06372145 |
| TG Therapeutics, Inc. | Ublituximab | — | ACTIVE NOT RECRUITING | 2032-05-31 | NCT04130997 |
| Novartis | Fingolimod | — | ACTIVE NOT RECRUITING | 2026-03-25 | NCT04926818 |
| Novartis | Ofatumumab approved dose | — | ACTIVE NOT RECRUITING | 2026-01-28 | NCT06869785 |
| Roche | Fenebrutinib | — | ACTIVE NOT RECRUITING | 2026-01-27 | NCT04586010 |
| Roche | Fenebrutinib | — | ACTIVE NOT RECRUITING | 2025-09-17 | NCT04544449 |
| Roche | Fenebrutinib | — | ACTIVE NOT RECRUITING | 2025-09-05 | NCT04586023 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2025-06-30 | NCT04548999 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2025-06-09 | NCT05123703 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2025-01-15 | NCT04035005 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2024-12-19 | NCT04544436 |
| Novartis | Interferon beta-1a | Interferon beta [EPC] | ACTIVE NOT RECRUITING | 2017-07-14 | NCT01892722 |
| TG Therapeutics, Inc. | Ublituximab | — | NOT YET RECRUITING | 2030-01-01 | NCT07220252 |
| Biogen | Diroximel Fumarate | Nicotinic acid receptor/Nrf2 | NOT YET RECRUITING | 2034-07-28 | NCT07483632 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2025-11-14 | NCT04458051 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2025-11-04 | NCT04788615 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2025-07-17 | NCT03599245 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2025-07-08 | NCT02283853 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2024-10-09 | NCT04353492 |
| Biogen | Diroximel fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2024-09-11 | NCT05083923 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2024-08-29 | NCT04411641 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2024-07-16 | NCT04410991 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2024-07-15 | NCT04410978 |
| Biocad | Divozilimab | — | COMPLETED | 2024-05-16 | NCT06987851 |
| Actelion | Ponesimod | Sphingosine 1-phosphate Receptor Modulator [EPC] | COMPLETED | 2024-01-16 | NCT03232073 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2023-11-20 | NCT04486716 |
| Bristol-Myers Squibb | Tetanus, diphtheria, and acellular pertussis vaccine | — | COMPLETED | 2023-11-15 | NCT05028634 |
| Mapi Pharma Ltd. | GA Depot | — | COMPLETED | 2023-06-13 | NCT04121221 |
| Clene Nanomedicine | CNM-Au8 | — | COMPLETED | 2023-05-29 | NCT04626921 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2023-04-11 | NCT02688985 |
| Roche | Ocrelizumab IV | — | COMPLETED | 2023-03-10 | NCT05232825 |
| Biogen | Natalizumab | Integrin Receptor Antagonist [EPC] | COMPLETED | 2023-01-31 | NCT03689972 |
| Bristol-Myers Squibb | RPC1063 | — | COMPLETED | 2023-01-05 | NCT02576717 |
| Biocad | BCD-132 | — | COMPLETED | 2022-09-09 | NCT05385744 |
| Novartis | Siponimod | Sphingosine 1-phosphate Receptor Modulator [EPC] | COMPLETED | 2022-07-06 | NCT03623243 |
| Jazz Pharmaceuticals | Nabiximols | — | COMPLETED | 2022-05-04 | NCT04657666 |
| Cinnagen | Pegylated interferon beta-1a | — | COMPLETED | 2022-04-27 | NCT05242133 |
| Polpharma Biologics S.A. | Intravenous (IV) infusions | — | COMPLETED | 2021-08-23 | NCT04115488 |
| Biogen | ALKS 8700 | — | COMPLETED | 2021-06-01 | NCT02634307 |
| Bionorica SE | BX-1 | — | COMPLETED | 2021-03-30 | NCT03756974 |
| Adamas Pharmaceuticals, Inc. | ADS-5102, 274 mg | — | COMPLETED | 2020-11-17 | NCT03567057 |
| Cinnagen | Ocrelizumab (CinnaGen, Iran) | — | COMPLETED | 2020-11-09 | NCT04966338 |
| TG Therapeutics, Inc. | Ublituximab | — | COMPLETED | 2020-08-04 | NCT03277248 |
| TG Therapeutics, Inc. | Ublituximab | — | COMPLETED | 2020-07-23 | NCT03277261 |
| RVL Pharmaceuticals, Inc. | Arbaclofen | — | COMPLETED | 2020-01-27 | NCT03319732 |
| Adamas Pharmaceuticals, Inc. | ADS-5102, 137 mg | — | COMPLETED | 2019-12-10 | NCT03436199 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2019-11-08 | NCT00835770 |
| Genzyme, a Sanofi Company | Teriflunomide | Pyrimidine Synthesis Inhibitor [EPC] | COMPLETED | 2019-10-25 | NCT02201108 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2019-10-25 | NCT02861014 |
| AB Science | Masitinib | — | COMPLETED | 2019-09 | NCT01433497 |
| Novartis | Ofatumumab subcutaneous injection | — | COMPLETED | 2019-07-05 | NCT02792218 |
| Biogen | ALKS 8700 | — | COMPLETED | 2019-06-27 | NCT03093324 |
| Roche | Ocrelizumab Dose 1 | — | COMPLETED | 2019-05-31 | NCT03606460 |
| Actelion | ponesimod | Sphingosine 1-phosphate Receptor Modulator [EPC] | COMPLETED | 2019-05-16 | NCT02425644 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2019-05-03 | NCT02637856 |
| RVL Pharmaceuticals, Inc. | Arbaclofen | — | COMPLETED | 2018-12-03 | NCT03290131 |
| Biocad | BCD-054 180 mcg | — | COMPLETED | 2018-11-23 | NCT02744222 |
| Novartis | Fingolimod | — | COMPLETED | 2018-10-19 | NCT01201356 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2018-09-24 | NCT02555215 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2017-04-24 | NCT02525874 |
| Bristol-Myers Squibb | Ozanimod | — | COMPLETED | 2017-03-27 | NCT02047734 |
| Roche | 23-PPV | — | COMPLETED | 2017-02-14 | NCT02545868 |
| Bristol-Myers Squibb | Ozanimod | — | COMPLETED | 2016-12-22 | NCT02294058 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2016-12-21 | NCT02579681 |
| Biocad | BCD-033 (interferon beta 1a) | — | COMPLETED | 2016-11-21 | NCT02727907 |
| Novartis | BAF312 | — | COMPLETED | 2016-04-29 | NCT01665144 |
| Genzyme, a Sanofi Company | alemtuzumab | CD52-directed Cytolytic Antibody [EPC] | COMPLETED | 2016-02 | NCT00930553 |
| Biogen | fampridine | — | COMPLETED | 2016-02 | NCT02219932 |
| Biogen | Midazolam | Benzodiazepine [EPC] | COMPLETED | 2016-01 | NCT01462318 |
| Biocad | BCD-063 | — | COMPLETED | 2015-11 | NCT02753088 |
| Biogen | BIIB041 (fampridine) | — | COMPLETED | 2015-10 | NCT01917019 |
| Biogen | BIIB017 | — | COMPLETED | 2015-10 | NCT01939002 |
| Biogen | peginterferon beta-1a | Interferon beta [EPC] | COMPLETED | 2015-10 | NCT01332019 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2015-07-23 | NCT01194570 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2015-06-16 | NCT01838668 |
| Roche | Interferon beta-1a | Interferon beta [EPC] | COMPLETED | 2015-05-12 | NCT01412333 |
| Teva Branded Pharmaceutical Products R&D, Inc. | Laquinimod | — | COMPLETED | 2015-04-13 | NCT01707992 |
Showing 100 of 130 trials (top 100 by completion date — export for full list)
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Vidya Therapeutics Inc | VT7208 | — | RECRUITING | 2026-10-30 | NCT07085507 |
| Roche | Ocrelizumab Test Formulation | — | RECRUITING | 2027-01-31 | NCT07074886 |
| Bristol-Myers Squibb | BMS-986368 | — | RECRUITING | 2027-05-26 | NCT06782490 |
| Roche | Fenebrutinib | — | RECRUITING | 2027-06-08 | NCT07161258 |
| Roche | RO7268489 | — | RECRUITING | 2028-05-30 | NCT07282574 |
| Tr1X, Inc. | TRX319 | — | RECRUITING | 2028-08 | NCT07477639 |
| Ever Supreme Bio Technology Co., Ltd. | Allogeneic umbilical cord mesenchymal stem cells | — | RECRUITING | 2028-10-31 | NCT05532943 |
| ModernaTX, Inc. | mRNA-1195 | — | RECRUITING | 2029-01-08 | NCT06735248 |
| Novartis | rapcabtagene autoleucel (YTB323) | — | RECRUITING | 2030-06-14 | NCT06675864 |
| Miltenyi Biomedicine GmbH | MB-CART2019.1 | — | RECRUITING | 2030-08-16 | NCT07178431 |
| Novartis | rapcabtagene autoleucel (YTB323) | — | RECRUITING | 2030-10-01 | NCT06617793 |
| Tiziana Life Sciences LTD | Foralumab TZLS-401 100 µg | — | RECRUITING | 2026-04-30 | NCT06890923 |
| Ashvattha Therapeutics, Inc. | 18F-OP-801 | — | RECRUITING | 2026-01-01 | NCT05395624 |
| Tiziana Life Sciences LTD | Foralumab | — | RECRUITING | 2025-11 | NCT06292923 |
| Hope Biosciences Research Foundation | Autologous HB-adMSCs | — | ACTIVE NOT RECRUITING | 2027-01 | NCT06800404 |
| Kyverna Therapeutics | KYV-101 | — | ACTIVE NOT RECRUITING | 2027-04 | NCT06384976 |
| Eli Lilly | LY3541860 | — | ACTIVE NOT RECRUITING | 2025-10-18 | NCT06220669 |
| Zenas BioPharma (USA), LLC | Obexelimab | — | ACTIVE NOT RECRUITING | 2025-08-28 | NCT06564311 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | ACTIVE NOT RECRUITING | 2023-10-05 | NCT04075266 |
| Roche | Fenebrutinib | — | ACTIVE NOT RECRUITING | 2023-03-29 | NCT05119569 |
| Sanofi | SAR441344 IV | — | ACTIVE NOT RECRUITING | 2022-09-21 | NCT04879628 |
| Immunic AG | IMU-838 (30 mg/day) | — | ACTIVE NOT RECRUITING | 2020-04-24 | NCT03846219 |
| TG Therapeutics, Inc. | Ublituximab | — | NOT YET RECRUITING | 2027-07-31 | NCT07503873 |
| NeuroGenesis Ltd. | NG01 - Autologous bone marrow derived human stromal cells | — | NOT YET RECRUITING | 2027-10-01 | NCT06961383 |
| Cabaletta Bio | CABA-201 | — | NOT YET RECRUITING | 2028-09 | NCT07006805 |
| Roche | Ocrelizumab co-formulated with rHuPH20 | — | NOT YET RECRUITING | 2029-08-01 | NCT07503340 |
| Biogen | BIIB091 | — | COMPLETED | 2026-02-10 | NCT05798520 |
| Reveal Pharmaceuticals Inc. | RVP-001 | — | COMPLETED | 2025-12-19 | NCT06322342 |
| Contineum Therapeutics | PIPE-307 Dose A | — | COMPLETED | 2025-07-14 | NCT06083753 |
| Clene Nanomedicine | gold nanocrystals | — | COMPLETED | 2025-05-27 | NCT03993171 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2024-11-26 | NCT03996291 |
| Hope Biosciences Research Foundation | HB-adMSCs | — | COMPLETED | 2024-06-04 | NCT05116540 |
| Actelion | Ponesimod 10 mg | — | COMPLETED | 2023-09-06 | NCT01093326 |
| TG Therapeutics, Inc. | Ublituximab | — | COMPLETED | 2022-11-11 | NCT03381170 |
| GeNeuro Innovation SAS | temelimab 18 mg/kg | — | COMPLETED | 2022-01-24 | NCT04480307 |
| AbbVie | elezanumab | — | COMPLETED | 2021-08-09 | NCT03737851 |
| Brainstorm-Cell Therapeutics | NurOwn (MSC-NTF cells) | — | COMPLETED | 2021-03-11 | NCT03799718 |
| AbbVie | elezanumab | — | COMPLETED | 2021-01-15 | NCT03737812 |
| Biocad | BCD-132, 125 mg | — | COMPLETED | 2020-07-13 | NCT04056897 |
| Sanofi | SAR442168 | — | COMPLETED | 2020-01-02 | NCT03889639 |
| Novartis | Ofatumumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2019-12-26 | NCT03249714 |
| Novartis | — | — | COMPLETED | 2019-08-26 | NCT03560739 |
| Canbex Therapeutics Ltd | VSN16R | — | COMPLETED | 2017-10 | NCT02542787 |
| TG Therapeutics, Inc. | Ublituximab | — | COMPLETED | 2017-09-27 | NCT02738775 |
| GeNeuro SA | GNbAC1 | — | COMPLETED | 2017-08 | NCT02782858 |
| Teva Branded Pharmaceutical Products R&D, Inc. | Laquinimod | — | COMPLETED | 2017-05-04 | NCT02284568 |
| Mapi Pharma Ltd. | GA Depot 80 mg | — | COMPLETED | 2017-05 | NCT02212886 |
| MediciNova | ibudilast | — | COMPLETED | 2017-05 | NCT01982942 |
| Innate Immunotherapeutics | MIS416 | — | COMPLETED | 2017-05 | NCT02228213 |
| InteKrin Therapeutics, Inc. | INT131 | — | COMPLETED | 2016-12-12 | NCT02638038 |
| Novartis | BAF312 | — | COMPLETED | 2016-10-10 | NCT01185821 |
| Opexa Therapeutics, Inc. | Tcelna | — | COMPLETED | 2016-10 | NCT01684761 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2016-09-23 | NCT02410200 |
| Biogen | BIIB019 (Daclizumab) | — | COMPLETED | 2016-08-25 | NCT01051349 |
| Adamas Pharmaceuticals, Inc. | ADS-5102 | — | COMPLETED | 2016-06 | NCT02471222 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2016-05-02 | NCT02097849 |
| Merck KGaA, Darmstadt, Germany | ATX-MS-1467 | — | COMPLETED | 2016-04-30 | NCT01973491 |
| Merck KGaA, Darmstadt, Germany | IFN beta 1a 44 mcg TIW | — | COMPLETED | 2016-03-31 | NCT01514370 |
| Translational Biosciences | Umbilical cord mesenchymal stem cells | — | COMPLETED | 2016-03 | NCT02034188 |
| Tanabe Pharma Corporation | MT-1303-Low | — | COMPLETED | 2016-03 | NCT01890655 |
| Biogen | BIIB033 | — | COMPLETED | 2015-12 | NCT01864148 |
| RedHill Biopharma Limited | RHB-104 | — | COMPLETED | 2015-12 | NCT01717664 |
| Merck KGaA, Darmstadt, Germany | VigantOL oil plus interferon beta-1a (Rebif) | — | COMPLETED | 2015-04 | NCT01285401 |
| Merck KGaA, Darmstadt, Germany | Rebif | Interferon beta [EPC] | COMPLETED | 2015-03 | NCT01198132 |
| Biogen | natalizumab | Integrin Receptor Antagonist [EPC] | COMPLETED | 2014-12 | NCT01416155 |
| GSK | GSK239512 | — | COMPLETED | 2014-09 | NCT01772199 |
| Tanabe Pharma Corporation | MT-1303-Low | — | COMPLETED | 2014-07 | NCT01742052 |
| Novartis | AIN457 | — | COMPLETED | 2014-06 | NCT01433250 |
| Delta Crystallon BV | recombinant human alpha B-crystallin | — | COMPLETED | 2014-06 | NCT02442570 |
| GeNeuro Innovation SAS | GNbAC1 | — | COMPLETED | 2014-04 | NCT01639300 |
| Biogen | natalizumab IV | — | COMPLETED | 2014-04 | NCT01405820 |
| MorphoSys AG | MOR103 | — | COMPLETED | 2014-01 | NCT01517282 |
| Neurotec Pharma | NT-KO-003 | — | COMPLETED | 2014-01 | NCT01428726 |
| Avanir Pharmaceuticals | AVP-923-45 | — | COMPLETED | 2013-09-26 | NCT01324232 |
| GSK | Ofatumumab 3mg | — | COMPLETED | 2013-08-23 | NCT01457924 |
| Biogen | BIIB041 (PR Fampridine) | — | COMPLETED | 2013-08 | NCT01597297 |
| Innate Immunotherapeutics | MIS416 | — | COMPLETED | 2012-06 | NCT01191996 |
| Biogen | BIIB019 (Daclizumab High Yield Process) | — | COMPLETED | 2012-05 | NCT00870740 |
| Novartis | AIN457 | — | COMPLETED | 2012-04 | NCT01051817 |
| Novartis | Fingolimod | — | COMPLETED | 2012-04 | NCT00670449 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2012-03-09 | NCT00676715 |
| Biogen | dimethyl fumarate | Nicotinic acid receptor/Nrf2 | COMPLETED | 2012-03 | NCT01156311 |
| Sanofi | teriflunomide | Pyrimidine Synthesis Inhibitor [EPC] | COMPLETED | 2012-01 | NCT01403376 |
| Ono Pharma USA Inc | ONO-4641 | — | COMPLETED | 2011-12 | NCT01081782 |
| Biogen | natalizumab | Integrin Receptor Antagonist [EPC] | COMPLETED | 2011-11 | NCT01071083 |
| Actelion | ACT-128800 Dose 1 | — | COMPLETED | 2011-06-01 | NCT01006265 |
| Novartis | BAF312 | — | COMPLETED | 2011-05-04 | NCT00879658 |
| Biogen | BIIB019 (Daclizumab High Yield Process) | — | COMPLETED | 2011-05 | NCT00390221 |
| Eli Lilly | LY2127399 | — | COMPLETED | 2011-02 | NCT00882999 |
| GSK | Ofatumumab 100 | — | COMPLETED | 2010-05 | NCT00640328 |
| Sanofi | Nerispirdine | — | COMPLETED | 2010-03 | NCT00811902 |
| Impax Laboratories, LLC | IPX056 | — | COMPLETED | 2010-01 | NCT00914290 |
| Sanofi | Nerispirdine | — | COMPLETED | 2009-06 | NCT00772525 |
| UCB Pharma | CDP323 | — | COMPLETED | 2009-03 | NCT00726648 |
| RemeGen Co., Ltd. | RC18 160mg | — | TERMINATED | 2026-04-03 | NCT04625153 |
| Mapi Pharma Ltd. | GA Depot 40mg once monthly | — | TERMINATED | 2025-06-20 | NCT03362294 |
| Sanofi | SAR443820 | — | TERMINATED | 2024-11-21 | NCT05630547 |
| Atara Biotherapeutics | ATA188 | — | TERMINATED | 2023-11-09 | NCT03283826 |
| GeNeuro Innovation SAS | Temelimab 18 mg/kg | — | TERMINATED | 2022-05-18 | NCT05049161 |
| Clene Nanomedicine | CNM-Au8 | — | TERMINATED | 2022-04-27 | NCT03536559 |
Showing 85 of 85 trials
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Roche | RO7121932 IV | — | RECRUITING | 2027-07-08 | NCT05704361 |
| Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | CC-97540 | — | RECRUITING | 2027-07-15 | NCT06220201 |
| AstraZeneca | AZD0120 - Regimen 1 | — | RECRUITING | 2028-12-07 | NCT07224373 |
| Kite, A Gilead Company | KITE-363 | — | RECRUITING | 2029-06 | NCT07304154 |
| Autolus Limited | Obecabtagene autoleucel (obe-cel) | — | RECRUITING | 2029-08-15 | NCT07139743 |
| Inventage Lab., Inc. | Vivitrol Injectable Product | — | RECRUITING | 2025-12-30 | NCT05620940 |
| ImStem Biotechnology | IMS001 | — | ACTIVE NOT RECRUITING | 2027-12 | NCT04956744 |
| Roche | P-CD19CD20-ALLO1 Cells | — | ACTIVE NOT RECRUITING | 2032-08-31 | NCT07008378 |
| Abata Therapeutics | ABA-101 | — | ACTIVE NOT RECRUITING | 2026-02 | NCT06566261 |
| R-Pharm | RPH-035 | — | ACTIVE NOT RECRUITING | 2026-01-12 | NCT07597668 |
| Polpharma Biologics International AG | US-Ocrevus | — | NOT YET RECRUITING | 2027-12 | NCT07606521 |
| Cellerys AG | CLS12311 low | — | COMPLETED | 2025-12-23 | NCT06430671 |
| Contineum Therapeutics | PIPE-791 | — | COMPLETED | 2025-06-04 | NCT06683612 |
| Roche | Ocrelizumab | CD20-directed Cytolytic Antibody [EPC] | COMPLETED | 2025-06-03 | NCT03972306 |
| Motric Bio | MTR-601 | — | COMPLETED | 2024-10-16 | NCT06117020 |
| LAPIX Therapeutics Inc. | LPX-TI641 | — | COMPLETED | 2024-08-15 | NCT05853835 |
| Anokion SA | ANK-700 | — | COMPLETED | 2024-04-23 | NCT04602390 |
| Contineum Therapeutics | PIPE-791 | — | COMPLETED | 2024-02-01 | NCT05983939 |
| GSK | GSK3888130B | — | COMPLETED | 2023-10-12 | NCT05131971 |
| Guangzhou Lupeng Pharmaceutical Company LTD. | LP-168 tablet | — | COMPLETED | 2022-11-20 | NCT05432713 |
| Merck KGaA, Darmstadt, Germany | Cladribine | Purine Antimetabolite [EPC] | COMPLETED | 2022-09-02 | NCT03745144 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2022-05-23 | NCT06106074 |
| Contineum Therapeutics | PIPE-307 | — | COMPLETED | 2021-11-10 | NCT04941781 |
| Sanofi | RIPK1 inhibitor | — | COMPLETED | 2021-10-11 | NCT04982991 |
| Contineum Therapeutics | PIPE-307 | — | COMPLETED | 2021-09-01 | NCT04725175 |
| Banner Life Sciences LLC | Monomethyl Fumarate 190 Mg | — | COMPLETED | 2021-08-27 | NCT05181215 |
| Sanofi | Tolebrutinib | — | COMPLETED | 2020-07-08 | NCT06064539 |
| Sanofi | SAR442168 | — | COMPLETED | 2019-12-30 | NCT04171310 |
| Banner Life Sciences LLC | Bafiertam | Nicotinic acid receptor/Nrf2 | COMPLETED | 2019-10-19 | NCT04022473 |
| GeNeuro Australia PTY Ltd | GNbAC1 | — | COMPLETED | 2018-11-02 | NCT03574428 |
| Biocad | BCD-132 | — | COMPLETED | 2018-10-18 | NCT03551275 |
| Abide Therapeutics | ABX-1431 HCl | — | COMPLETED | 2018-07-23 | NCT03138421 |
| Sanofi | GZ402668 | — | COMPLETED | 2018-05-16 | NCT02977533 |
| AbbVie | ABT-555 | — | COMPLETED | 2018-04-20 | NCT02601885 |
| Bristol-Myers Squibb | RPC1063 | — | COMPLETED | 2017-10-20 | NCT02797015 |
| Acorda Therapeutics | rHIgM22 | — | COMPLETED | 2017-09 | NCT02398461 |
| Banner Life Sciences LLC | monomethyl fumarate 190 mg | — | COMPLETED | 2017-02-17 | NCT04570670 |
| Biogen | BIIB033 (opicinumab) | — | COMPLETED | 2016-11 | NCT02833142 |
| Arrien Pharmaceuticals | ARN-6039 | — | COMPLETED | 2016-10-06 | NCT03237832 |
| Biogen | BIIB033 | — | COMPLETED | 2016-09 | NCT02641041 |
| GE Healthcare | Arm 1 - GEH120714 (18F) Injection | — | COMPLETED | 2016-05 | NCT01738347 |
| Genzyme, a Sanofi Company | Acyclovir | Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC] | COMPLETED | 2016-03 | NCT02583594 |
| Genzyme, a Sanofi Company | GZ402668 | — | COMPLETED | 2016-03 | NCT02282826 |
| Pfenex, Inc | Interferon beta-1b (PF530, Betaferon) | — | COMPLETED | 2015-10 | NCT02474134 |
| Biogen | BIIB061 | — | COMPLETED | 2015-08 | NCT02521545 |
| Tanabe Pharma Corporation | MT-1303-FormA | — | COMPLETED | 2015-03 | NCT02310048 |
| MedImmune LLC | MEDI-551 30 MG-IV | — | COMPLETED | 2015-01-02 | NCT01585766 |
| Biogen | Study Drug | — | COMPLETED | 2014-12 | NCT02201849 |
| Tanabe Pharma Corporation | MT-1303 | — | COMPLETED | 2014-12 | NCT02293967 |
| Biogen | peginterferon beta-1a | Interferon beta [EPC] | COMPLETED | 2014-12 | NCT02269930 |
| Vaccinex Inc. | VX15/2503 | — | COMPLETED | 2014-11 | NCT01764737 |
| Acorda Therapeutics | rHIgM22 | — | COMPLETED | 2014-10 | NCT01803867 |
| Biogen | Natalizumab | Integrin Receptor Antagonist [EPC] | COMPLETED | 2014-09 | NCT01884935 |
| Sanofi | Teriflunomide HMR1726 | — | COMPLETED | 2014-07 | NCT02046629 |
| Roche | olesoxime (TRO19622) | — | COMPLETED | 2014-01 | NCT01808885 |
| Apitope Technology (Bristol) Ltd. | ATX-MS-1467 | — | COMPLETED | 2013-07 | NCT01097668 |
| GSK | GSK239512 | — | COMPLETED | 2013-04-15 | NCT01802931 |
| Biogen | — | — | COMPLETED | 2012-10 | NCT01610310 |
| Biogen | BIIB033 | — | COMPLETED | 2012-04 | NCT01244139 |
| Biogen | Interferon beta-1a (current approved manufacturing process invloving FBS) | — | COMPLETED | 2012-04 | NCT01500408 |
| GeNeuro Innovation SAS | GNbAC1 | — | COMPLETED | 2012-03 | NCT01699555 |
| GSK | Firategrast immediate release tablet | — | COMPLETED | 2011-09-17 | NCT01416363 |
| GSK | GSK2018682 | — | COMPLETED | 2011-03-29 | NCT01431937 |
| GSK | GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state | — | COMPLETED | 2011-02-15 | NCT01466322 |
| GSK | GSK2018682 | — | COMPLETED | 2010-12-20 | NCT01387217 |
| Delta Crystallon BV | recombinant human alpha B-crystallin | — | COMPLETED | 2010-10 | NCT02442557 |
| Daiichi Sankyo | CS-0777 tablets | — | COMPLETED | 2010-09 | NCT00616733 |
| GSK | A | — | COMPLETED | 2010-07-06 | NCT01424462 |
| Bayer | F-18 FEDAA1106 (BAY85-8101) | — | COMPLETED | 2009-12 | NCT01031199 |
| Biogen | BG00012 | — | COMPLETED | 2009-10-31 | NCT00837785 |
| Merck KGaA, Darmstadt, Germany | Cladribine | Purine Antimetabolite [EPC] | COMPLETED | 2009-01 | NCT00938366 |
| Bristol-Myers Squibb | 11C-BMS-986196 | — | TERMINATED | 2023-12-18 | NCT05064436 |
| H. Lundbeck A/S | Lu AG06466 | — | TERMINATED | 2023-01-19 | NCT04990219 |
| American CryoStem Corporation | Autologous adipose derived mesenchymal cells | — | TERMINATED | 2018-05-18 | NCT02326935 |
| AbbVie | ABT-555 | — | TERMINATED | 2015-12 | NCT02606630 |
| Pfizer | PF-06342674 0.25 mg/kg | — | TERMINATED | 2015-10 | NCT02045732 |
| BBB-Therapeutics B.V. | 2B3-201 | — | TERMINATED | 2015-01 | NCT02048358 |
| GSK | Part A: 100 mg/mL GSK2618960 | — | TERMINATED | 2013-08-06 | NCT01808482 |
| Elan Pharmaceuticals | ELND002 | — | TERMINATED | 2012-12 | NCT01318421 |
| Elan Pharmaceuticals | ELND002 | — | TERMINATED | 2012-12 | NCT01144351 |
| GSK | GSK1223249 | — | TERMINATED | 2012-01-23 | NCT01435993 |
| GSK | GSK1223249 | — | TERMINATED | 2010-08-26 | NCT01424423 |
| Indapta Therapeutics, INC. | IDP-023 | — | SUSPENDED | 2026-12-31 | NCT06677710 |
| Tiziana Life Sciences LTD | Intranasal Foralumab Solution | — | WITHDRAWN | 2022-11 | NCT05029609 |
| Healeon Medical Inc | — | — | WITHDRAWN | 2022-10 | NCT02939859 |
Novel Multiple Sclerosis Drugs by Company (New molecular entities)
7 companies have an FDA-approved novel drug for Multiple Sclerosis.
Reformulations (7 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Multiple Sclerosis Drug Targets
Molecular targets of approved and investigational Multiple Sclerosis drugs — 17 targets tracked.
Biosimilars (1 BLA approved) Click to expand
Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.
Generic Drugs (8 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs