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Acute Lymphoblastic Leukemia

Oncology 6 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

Oncology indication. Acute Lymphoblastic Leukemia has 6 FDA-approved novel treatments, led by Merck across 27 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Acute Lymphoblastic Leukemia Market Leaders

Companies with the most FDA-approved novel Acute Lymphoblastic Leukemia drugs.

Phase 3 Readouts Pro

4 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q1 2027

CTL019

Novartis

Estimated · fresh NCT04094311

Q3 2027

Venetoclax

AbbVie

Estimated · fresh NCT03844048

Q3 2029

Blinatumomab

Amgen

Estimated · fresh NCT04994717

Unlock 1 more readouts with confidence-graded estimates

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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.

Acute Lymphoblastic Leukemia Treatments by Mechanism

Top 12 mechanisms across 32 industry trials with a known mechanism of action.

See full pipeline →

CD19/CD3

14 trials 4 active 2 sponsors

CD22-directed Immunoconjugate

4 trials 1 active 1 sponsor

BCL-2 Inhibitor

1 trials 1 active 1 sponsor

Menin Inhibitor

1 trials 1 active 1 sponsor

CD19-directed Chimeric Antigen Receptor

3 trials 1 sponsor

DNA

2 trials 2 sponsors

Nucleoside Metabolic Inhibitor

2 trials 2 sponsors

Factor Xa Inhibitor

1 trials 1 sponsor

Asparagine-specific Enzyme

1 trials 1 sponsor

CD19

1 trials 1 sponsor

DNA polymerase alpha/DNA primase/Ribonucleotide reductase

1 trials 1 sponsor

Kinase 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.

Acute Lymphoblastic Leukemia Clinical Pipeline by Phase

183 industry-sponsored trials across 101 sponsors

Showing 4 of 4 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Pfizer	inotuzumab ozogamicin	CD22-directed Immunoconjugate [EPC]	COMPLETED	2024-08-07	NCT05687032
Novartis	Nilotinib	—	COMPLETED	2023-07-07	NCT01735955
Pfizer	inotuzumab ozogamicin-dose level 2	—	COMPLETED	2022-09-21	NCT03677596
Amgen	Blinatumomab	CD19/CD3	TERMINATED	2024-07-04	NCT04506086

Showing 20 of 20 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Novartis	CTL019	—	RECRUITING	2027-03-31	NCT04094311
Merck	MK-1045	—	RECRUITING	2033-10-18	NCT07570173
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	ACTIVE NOT RECRUITING	2027-08	NCT03844048
Amgen	Blinatumomab	CD19/CD3	ACTIVE NOT RECRUITING	2029-09-07	NCT04994717
Takeda	Ponatinib	—	ACTIVE NOT RECRUITING	2022-08-12	NCT03589326
Amgen	Blinatumomab	CD19/CD3	NOT YET RECRUITING	2030-05-10	NCT07223190
Jazz Pharmaceuticals	IM JZP-458	—	COMPLETED	2022-07-13	NCT04145531
Bristol-Myers Squibb	Apixaban	Factor Xa Inhibitor [EPC]	COMPLETED	2021-07-07	NCT02369653
Gamida Cell ltd	NiCord® (omidubicel)	—	COMPLETED	2021-04-29	NCT02730299
Novartis	CTL019	—	COMPLETED	2020-10-13	NCT03123939
Amgen	Blinatumomab	CD19/CD3	COMPLETED	2019-08-21	NCT03476239
Mesoblast, Ltd.	Infusion of one MPC expanded cord unit and one unexpanded cord unit	—	COMPLETED	2016-09-23	NCT01854567
Pfizer	inotuzumab ozogamicin	CD22-directed Immunoconjugate [EPC]	COMPLETED	2016-03-08	NCT01564784
ERYtech Pharma	GRASPA	—	COMPLETED	2014-09	NCT01518517
medac GmbH	asparaginase	Asparagine-specific Enzyme [EPC]	COMPLETED	2012-10	NCT00784017
Kiadis Pharma	ATIR101	—	TERMINATED	2021-11-09	NCT02999854
Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Efprezimod alfa	—	TERMINATED	2021-11-05	NCT04095858
Amgen	Blinatumomab	CD19/CD3	TERMINATED	2015-12-29	NCT02013167
Spectrum Pharmaceuticals, Inc	Vincristine Sulfate Liposomes Injection (VSLI)	—	TERMINATED	2015-11	NCT01439347
Novartis	Tisagenlecleucel	CD19-directed Chimeric Antigen Receptor [EPC]	WITHDRAWN	2025-10-08	NCT03628053

Showing 87 of 87 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
AstraZeneca	AZD0486	—	RECRUITING	2026-11-13	NCT06137118
Wugen, Inc.	WU-CART-007	—	RECRUITING	2026-12-30	NCT06514794
Excyte Biopharma Ltd	YK012	—	RECRUITING	2026-12-31	NCT06580301
Beijing Biotech	Autologous CD19/CD22 dual-target CAR-T module	—	RECRUITING	2027-03-14	NCT07523555
Vironexis Biotherapeutics Inc.	—	—	RECRUITING	2027-06	NCT06533579
Syndax Pharmaceuticals	revumenib	—	RECRUITING	2027-12-15	NCT04065399
Incyte Biosciences International Sàrl	Ponatinib	—	RECRUITING	2028-02-01	NCT03934372
AstraZeneca	—	—	RECRUITING	2028-04-28	NCT07109219
MSD R&D (China) Co., Ltd.	MK-1045	—	RECRUITING	2028-06-30	NCT05579132
BIOHENG THERAPEUTICS US LLC	CTD402 CAR T Cell Injection	—	RECRUITING	2028-09-30	NCT07070219
Merck	Zilovertamab vedotin	—	RECRUITING	2029-03-31	NCT06395103
Pfizer	Inotuzumab ozogamicin	CD22-directed Immunoconjugate [EPC]	RECRUITING	2033-10-31	NCT05748171
Cellectis S.A.	UCART22	—	RECRUITING	2026-06-30	NCT04150497
Ossium Health, Inc.	—	—	RECRUITING	2026-05-31	NCT05589896
Beijing Yongtai Ruike Biotechnology Company Ltd	CAR-T-19 cell injection	—	RECRUITING	2025-06-30	NCT06179524
Juventas Cell Therapy Ltd.	single dose of CNCT19	—	RECRUITING	2025-05-30	NCT05667506
Shenzhen TargetRx Co., Ltd.	TGRX-814	—	RECRUITING	2025-02-28	NCT06206174
Chongqing Precision Biotech Co., Ltd	pCAR-19B cells	—	RECRUITING	2024-12-31	NCT05334823
Juventas Cell Therapy Ltd.	single dose of CNCT19	—	RECRUITING	2022-09-22	NCT04684147
Novartis	Rapcabtagene autoleucel single agent	—	ACTIVE NOT RECRUITING	2027-06-30	NCT03960840
Kite, A Gilead Company	KTE-X19	—	ACTIVE NOT RECRUITING	2027-07	NCT06253663
Novartis	CTL019	—	ACTIVE NOT RECRUITING	2027-10-19	NCT03876769
Amgen	Blinatumomab	CD19/CD3	ACTIVE NOT RECRUITING	2027-11-24	NCT04521231
Kura Oncology, Inc.	Ziftomenib	Menin Inhibitor [EPC]	ACTIVE NOT RECRUITING	2028-10-16	NCT04067336
Amgen	Blinatumomab	CD19/CD3	ACTIVE NOT RECRUITING	2028-12-05	NCT07134088
Autolus Limited	AUTO1	—	ACTIVE NOT RECRUITING	2029-06-30	NCT04404660
Amgen	Blinatumomab	CD19/CD3	ACTIVE NOT RECRUITING	2026-01-05	NCT06054113
Otsuka Beijing Research Institute	Ponatinib 30mg OD	—	ACTIVE NOT RECRUITING	2022-07-22	NCT04233346
Bellicum Pharmaceuticals	BPX-501 T cells	—	ACTIVE NOT RECRUITING	2021-05-11	NCT03301168
Bellicum Pharmaceuticals	BPX-501 dose 1	—	ACTIVE NOT RECRUITING	2019-10-09	NCT01744223
Novartis	Asciminib Adult formulation	—	NOT YET RECRUITING	2033-07-18	NCT07387926
Kite, A Gilead Company	Brexucabtagene Autoleucel (KTE-X19)	—	COMPLETED	2026-03-25	NCT02625480
TCR2 Therapeutics	TC-110 T Cells	—	COMPLETED	2023-02-24	NCT04323657
Kite, A Gilead Company	brexucabtagene autoleucel	CD19	COMPLETED	2022-07-23	NCT02614066
Fate Therapeutics	ProTmune	—	COMPLETED	2020-12-04	NCT02743351
Autolus Limited	AUTO3 (CD19/22 CAR T cells	—	COMPLETED	2020-05-18	NCT03289455
Incyte Corporation	Ponatinib	—	COMPLETED	2020-04-24	NCT01641107
Novartis	CTL019	—	COMPLETED	2020-01-21	NCT02435849
Amgen	Blinatumomab	CD19/CD3	COMPLETED	2019-02-06	NCT02412306
Ariad Pharmaceuticals	Ponatinib	—	COMPLETED	2018-12-20	NCT01207440
Nohla Therapeutics, Inc.	Cyclophosphamide	DNA	COMPLETED	2018-09-18	NCT01690520
Ariad Pharmaceuticals	ponatinib - Phase 1	—	COMPLETED	2018-08-02	NCT01667133
Kiadis Pharma	ATIR101	—	COMPLETED	2018-07	NCT02500550
Novartis	CTL019 T-cells	—	COMPLETED	2018-05-29	NCT02228096
Eli Lilly	LY3039478	—	COMPLETED	2018-01-15	NCT02518113
BioSight Ltd.	Astarabine (BST-236)	—	COMPLETED	2017-09-20	NCT02544438
Gamida Cell ltd	NiCord®	—	COMPLETED	2017-06	NCT01816230
Delta-Fly Pharma, Inc.	DFP-10917	—	COMPLETED	2017-01-18	NCT01702155
Novartis	HSC835	—	COMPLETED	2016-10-03	NCT01474681
Sellas Life Sciences Group	Galinpepimut-S	—	COMPLETED	2016-09-30	NCT01266083
Novartis	HSC835	—	COMPLETED	2016-08-29	NCT01930162
Kiadis Pharma	ATIR	—	COMPLETED	2016-06	NCT01794299
Polyphor Ltd.	POL6326	—	COMPLETED	2015-11	NCT01413568
Jazz Pharmaceuticals	CPX-351	—	COMPLETED	2015-05	NCT02238925
Cellerant Therapeutics	human myeloid progenitor cells	—	COMPLETED	2014-11	NCT01297543
Nohla Therapeutics, Inc.	fludarabine phosphate	DNA polymerase alpha/DNA primase/Ribonucleotide reductase	COMPLETED	2014-08	NCT01175785
Pfizer	Inotuzumab Ozogamicin	CD22-directed Immunoconjugate [EPC]	COMPLETED	2014-08	NCT01363297
Amgen Research (Munich) GmbH	Blinatumomab	CD19/CD3	COMPLETED	2014-08	NCT01471782
Amgen Research (Munich) GmbH	Blinatumomab	CD19/CD3	COMPLETED	2014-02	NCT01207388
Traws Pharma, Inc.	rigosertib	—	COMPLETED	2013-12	NCT01167166
Amgen Research (Munich) GmbH	Blinatumomab	CD19/CD3	COMPLETED	2013-10	NCT01466179
Jazz Pharmaceuticals	asparaginase Erwinia chrysanthemi	—	COMPLETED	2013-08	NCT01643408
Gamida Cell ltd	NiCord®	—	COMPLETED	2012-09	NCT01221857
Betta Pharmaceuticals Co., Ltd.	Clofarabine	Nucleoside Metabolic Inhibitor [EPC]	COMPLETED	2011-11	NCT02544789
ERYtech Pharma	GRASPA	—	COMPLETED	2011-01	NCT01523782
Amgen Research (Munich) GmbH	Blinatumomab (MT103)	—	COMPLETED	2009-09	NCT00560794
Roche	Idasanutlin	—	TERMINATED	2024-05-06	NCT04029688
Takeda	Ponatinib	—	TERMINATED	2023-12-19	NCT04501614
Sanofi	Isatuximab	—	TERMINATED	2022-09-12	NCT03860844
Novartis	Tisagenlecleucel	CD19-directed Chimeric Antigen Receptor [EPC]	TERMINATED	2021-10-19	NCT04225676
Ensoma	MGTA-145	—	TERMINATED	2021-09-14	NCT04762875
OncoTherapy Science, Inc.	OTS167IV	—	TERMINATED	2021-05	NCT02795520
Bellicum Pharmaceuticals	Rimiducid	—	TERMINATED	2020-06-30	NCT03733249
Bellicum Pharmaceuticals	BPX-501 T cells	—	TERMINATED	2020-06	NCT02065869
Gilead	Entospletinib	—	TERMINATED	2018-11-16	NCT02404220
Juno Therapeutics, a Subsidiary of Celgene	JCAR015 (CD19-targeted CAR T cells)	—	TERMINATED	2017-04-24	NCT02535364
Celldex Therapeutics	CDX-301	—	TERMINATED	2016-03	NCT02200380
MorphoSys AG	MOR00208 (formerly Xmab5574)	—	TERMINATED	2015-03	NCT01685021
Jazz Pharmaceuticals	pegcrisantaspase	—	TERMINATED	2015-02	NCT02257684
Novartis	midostaurin	Kinase Inhibitor [EPC]	TERMINATED	2014-09	NCT00866281
Texas Oncology Cancer Center	Busulfan	Alkylating Drug [EPC]	TERMINATED	2013-11	NCT01500161
Juventas Cell Therapy Ltd.	HY004	—	WITHDRAWN	2026-12-30	NCT06009107
Guangzhou Bio-gene Technology Co., Ltd	CD7 CAR-T	—	WITHDRAWN	2028-08-01	NCT05909527
Novartis	Tisagenlecleucel	CD19-directed Chimeric Antigen Receptor [EPC]	WITHDRAWN	2022-11-30	NCT04156659
Matinas BioPharma Nanotechnologies, Inc.	Oral Encochleated Amphotericin B (CAMB)	—	WITHDRAWN	2020-12	NCT03187691
Jazz Pharmaceuticals	CPX-351	—	WITHDRAWN	2017-06	NCT02269579
Jazz Pharmaceuticals	Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)	—	WITHDRAWN	2015-06	NCT02150928

Showing 72 of 72 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
PersonGen BioTherapeutics (Suzhou) Co., Ltd.	LV009 Injection	—	RECRUITING	2026-12-03	NCT07284927
Newave Pharmaceutical Inc	LP-118	—	RECRUITING	2026-12-31	NCT04771572
Imugene Limited	Azer-cel	—	RECRUITING	2027-06	NCT03666000
Autolus Limited	AUTO1	—	RECRUITING	2027-11	NCT06173518
OneChain Immunotherapeutics	CD1a-CAR T	—	RECRUITING	2027-12	NCT05679895
Orca Biosystems, Inc.	OrcaGraft (Orca-Q)	—	RECRUITING	2027-12	NCT03802695
Chongqing Precision Biotech Co., Ltd	Invivo CAR-T	—	RECRUITING	2027-12-31	NCT07239323
TriArm Therapeutics (Taiwan) Limited	ARM011	—	RECRUITING	2028-04-01	NCT07066397
Allterum Therapeutics, Inc	4A10	—	RECRUITING	2028-05	NCT07586618
Ascentage Pharma Group Inc.	Ascentage Pharma HQP1351 bioavailable inhibitor	—	RECRUITING	2029-12-27	NCT04260022
Meryx, Inc.	MRX-2843	—	RECRUITING	2026-07	NCT04872478
Johnson & Johnson	14C-bleximenib	—	RECRUITING	2026-06-14	NCT07295951
Tr1X, Inc.	TRX103	—	RECRUITING	2026-04-15	NCT06462365
Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.	B019	—	RECRUITING	2026-01-31	NCT06927466
FamiCordTx	FCTX-CL19-1 (Tarcidomgen Kimleucel)	—	RECRUITING	2025-06	NCT06593145
Vincerx Pharma, Inc.	VIP943 (QW)	—	RECRUITING	2025-05-30	NCT06034275
Novartis	PIT565	—	ACTIVE NOT RECRUITING	2026-08-20	NCT05397496
PeproMene Bio, Inc.	BAFFR-CAR T cells	—	ACTIVE NOT RECRUITING	2026-11-18	NCT04690595
Miltenyi Biomedicine GmbH	MB-CART19.1	—	ACTIVE NOT RECRUITING	2026-06	NCT03853616
Sichuan Baili Pharmaceutical Co., Ltd.	GNC-038	—	ACTIVE NOT RECRUITING	2025-12	NCT04606433
Fate Therapeutics	FT819	—	ACTIVE NOT RECRUITING	2025-06-18	NCT04629729
Nkarta, Inc.	NKX019	—	ACTIVE NOT RECRUITING	2025-03-31	NCT05020678
Chongqing Precision Biotech Co., Ltd	MC-1-50	—	NOT YET RECRUITING	2027-11-01	NCT06641024
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	FXS0683	—	NOT YET RECRUITING	2028-08-07	NCT07616089
Guangdong Ruishun Biotech Co., Ltd	RS001 injection	—	NOT YET RECRUITING	2026-04-01	NCT06894693
Newave Pharmaceutical Inc	LP-108	—	COMPLETED	2025-12-19	NCT04139434
Amgen	Blinatumomab	CD19/CD3	COMPLETED	2025-07-30	NCT06649006
Kymera Therapeutics, Inc.	KT-253	—	COMPLETED	2024-12-18	NCT05775406
Wugen, Inc.	WU-CART-007	—	COMPLETED	2024-08-08	NCT04984356
Syndax Pharmaceuticals	Revumenib	—	COMPLETED	2024-07-29	NCT05326516
Amgen	Carfilzomib	Proteasome Inhibitor [EPC]	COMPLETED	2024-06-28	NCT02303821
AbbVie	chemotherapy	—	COMPLETED	2023-04-19	NCT03236857
Amgen	Blinatumomab	CD19/CD3	COMPLETED	2023-01-24	NCT04524455
Shanghai Simnova Biotechnology Co.,Ltd.	CAR-NK-CD19 Cells	—	COMPLETED	2022-11-25	NCT05563545
AstraZeneca	AZD4573	—	COMPLETED	2021-09-30	NCT03263637
Xencor, Inc.	XmAb14045	—	COMPLETED	2021-09	NCT02730312
Chongqing Precision Biotech Co., Ltd	pCAR-19B cells	—	COMPLETED	2021-06-29	NCT04888468
Novartis	Asciminib (ABL001)	—	COMPLETED	2021-06-03	NCT02081378
Hebei Senlang Biotechnology Inc., Ltd.	CD7 CAR-T	—	COMPLETED	2021-05-30	NCT04572308
Jazz Pharmaceuticals	CPX-351	—	COMPLETED	2021-05-26	NCT03555955
Angiocrine Bioscience	Unmanipulated Umbilical Cord Blood (UCB)	—	COMPLETED	2020-12-21	NCT03483324
Juventas Cell Therapy Ltd.	single dose of CNCT19	—	COMPLETED	2020-12-01	NCT04230473
AbbVie	Navitoclax	—	COMPLETED	2020-11-11	NCT03181126
Bio-Path Holdings, Inc.	BP1001	—	COMPLETED	2017-03-30	NCT01159028
Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	OTX015/Birabresib	—	COMPLETED	2017-01-20	NCT01713582
Calithera Biosciences, Inc	CB-839	—	COMPLETED	2016-10	NCT02071927
Epizyme, Inc.	EPZ-5676	—	COMPLETED	2016-05	NCT02141828
Tragara Pharmaceuticals, Inc.	TG02 citrate	—	COMPLETED	2016-03	NCT01204164
Epizyme, Inc.	EPZ-5676	—	COMPLETED	2015-11	NCT01684150
Novartis	Nilotinib	—	COMPLETED	2015-07-01	NCT01077544
MedImmune LLC	CAT-8015 (Moxetumomab Pasudotox)	—	COMPLETED	2014-12	NCT00659425
Traws Pharma, Inc.	ON 01910.Na	—	COMPLETED	2014-11	NCT00854646
Fate Therapeutics	Single FT1050 treated UCB unit	—	COMPLETED	2013-10	NCT01527838
Threshold Pharmaceuticals	TH-302	—	COMPLETED	2013-08	NCT01149915
Millennium Pharmaceuticals, Inc.	MLN4924	—	COMPLETED	2013-08	NCT00911066
AbbVie (prior sponsor, Abbott)	ABT-348	—	COMPLETED	2013-06	NCT01110473
Nova Laboratories Limited	Mercaptopurine 20mg/ml oral suspension	—	COMPLETED	2012-11	NCT01697020
Millennium Pharmaceuticals, Inc.	TAK-901	—	COMPLETED	2012-09	NCT00807677
Genzyme, a Sanofi Company	Clofarabine	Nucleoside Metabolic Inhibitor [EPC]	COMPLETED	2011-05	NCT01196013
Synta Pharmaceuticals Corp.	STA-9090 (ganetespib)	—	COMPLETED	2010-12	NCT00964873
Biomea Fusion Inc.	BMF-219	—	TERMINATED	2025-02-13	NCT05153330
Eden BioCell Ltd.	RPM CD19-mbIL15-CAR-T cells	—	TERMINATED	2022-05-12	NCT04844086
Tarix Pharmaceuticals	TXA127 300 mcg/kg/day	—	TERMINATED	2020-12	NCT01300611
ADC Therapeutics S.A.	ADCT-301	—	TERMINATED	2018-08-29	NCT02588092
ADC Therapeutics S.A.	ADCT-402	—	TERMINATED	2018-07-03	NCT02669264
ERYtech Pharma	L-asparaginase encapsulated in RBC	—	TERMINATED	2018-01-25	NCT01910428
Traws Pharma, Inc.	ON 013105	—	TERMINATED	2014-12	NCT01049113
Novartis	Gleevec/Glivec	—	TERMINATED	2011-05	NCT01066468
Merck	—	—	TERMINATED	2010-04	NCT00860535
Novartis	IMJ995 single agent	—	WITHDRAWN	2026-08-13	NCT05168748
Johnson & Johnson	JNJ-75276617	—	WITHDRAWN	2026-09-11	NCT05521087
Ossium Health, Inc.	Cyclophosphamide	DNA	WITHDRAWN	2024-03	NCT05170828

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Acute Lymphoblastic Leukemia

RET (12) FLT3 (10) FGFR (8) BCR-ABL (7) PDGFR gene re-arrangement (2) Kit (CD117) positive (2)

Novel Acute Lymphoblastic Leukemia Drugs by Company (New molecular entities)

6 companies have an FDA-approved novel drug for Acute Lymphoblastic Leukemia.

Merck 1 drug

JAZZ PHARMS 1 drug

ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN

Amgen 1 drug

Pfizer 1 drug

INOTUZUMAB OZOGAMICIN

BLA 2017

SERVIER PHARMA LLC 1 drug

ASPARLAS

CALASPARGASE PEGOL-MKNL

SHORLA 1 drug

Reformulations (8 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.