Data updated: Jun 28, 2026
APREMILAST
Immunology
Approved 2014-03-21
13
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2014-03-21
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Dr. Reddy's AMNEAL UNICHEM TORRENT ZYDUS PHARMS MSN SHILPA MANKIND PHARMA ALKEM LABS LTD GLENMARK PHARMS LTD Aurobindo Pharma ANNORA Teva MACLEODS PHARMS LTD
Active Ingredient: APREMILAST
Website: ↗
APREMILAST Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
39 FDA actions from 2021 to 2025
Nov 2024 ORIGINAL
Update
Jul 2023 ORIGINAL
Update
Aug 2022 ORIGINAL
Update
What APREMILAST Treats
13 FDA approvalsOriginally approved for its first indication in 2021 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Feb 2021)Letter
- • Approved indication (Jun 2021)Letter
- • Approved indication (Sep 2021)Letter
- • Approved indication (Aug 2022)
- • Approved indication (Apr 2023)Letter
- • Approved indication (Jul 2023)Letter
- • Approved indication (Jul 2023)
- • Approved indication (Jul 2023)Letter
- • Approved indication (Oct 2023)Letter
- • Approved indication (Feb 2024)Letter
- • Approved indication (Nov 2024)
- • Approved indication (Dec 2024)Letter
- • Approved indication (Jun 2025)Letter
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Clinical Trial Registry
78 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07325266 | HLAB-004 | Ph 2 | recruiting | Human Laboratory Study of Apremilast for Alcohol Use Disorder |
| NCT05703685 | 10000676 000676-M | Ph 1 | recruiting | [18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET |
| NCT04804553 PEAPOD | 20190529 | Ph 3 | recruiting | Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis |
| NCT06586112 ONWARD1 | ESK-001-016 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis |
| NCT06588738 ONWARD2 | ESK-001-017 | Ph 3 | completed | A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 |
| NCT03036995 Rapid Vitiligo | 16-PP-06 | Ph 2 | completed | Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO |
| NCT04488081 I-SPY_COVID | I-SPY-COVID | Ph 2 | active not recruiting | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT07432386 | PEMH-DERM-RCT-2026-01 | Ph 4 | not yet recruiting | Methotrexate Versus Apremilast for Pruritus in Psoriasis |
| NCT04227314 PREMS | 2019/0411/HP | Ph 3 | recruiting | Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis |
| NCT06324435 | 2000037439 1U54AA027989-01 | Ph 1 | active not recruiting | Apremilast for Alcohol Use Disorder Treatment in Women and Men |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT06122649 ESSENCE | 20200250 | Ph 3 | completed | A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO) |
| NCT04175613 | CC-10004-PPSO-004 U1111-1242-3537, 2019-003497-13 | Ph 3 | completed | A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis |
| NCT05565560 | 20200346 | Ph 3 | active not recruiting | A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis |
| NCT06260904 | AIIMS BBSR/PGThesis/23-24/112 | Ph 4 | completed | Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus |
| NCT05767047 | 20190531 2022-003024-41, 2023-503433-21 | Ph 3 | recruiting | A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis |
| NCT04528082 BEAN | 20190530 2023-503436-40-00 | Ph 3 | recruiting | Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease |
| NCT06108544 | TAK-279-3002 2023-505842-24-00 | Ph 3 | completed | A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period |
| NCT06088199 | 20200196 | Ph 3 | active not recruiting | A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis |
| NCT06088043 | TAK-279-3001 jRCT2031230583, 2023-505841-22-00 | Ph 3 | completed | A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment |
| NCT05875714 AEM results posted | 842831 | Ph 2 | completed | Apremilast for Erythema Multiforme |
| NCT03774875 EMBRACE results posted | CC-10004-PSOR-020 U1111-1224-8381, 2018-002850-58 | Ph 4 | completed | A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life |
| NCT04908189 results posted | IM011-055 2020-005099-36, U1111-1259-9466 | Ph 3 | active not recruiting | A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment |
| NCT05174065 results posted | 20200195 | Ph 3 | completed | Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP) |
| NCT03783026 MOSAIC results posted | CC-10004-PSA-014 U1111-1223-9823, 2018-002748-10 | Ph 4 | completed | A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis |
| NCT04057937 results posted | CC-10004-PPP-001 U1111-1236-1239 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT03022617 results posted | IRB-160720004 | Ph 4 | completed | A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis |
| NCT03721172 ADVANCE results posted | CC-10004-PSOR-022 U1111-1218-8372 | Ph 3 | completed | Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy |
| NCT03777436 DISCREET results posted | CC-10004-PSOR-025 U1111-1224-6850, 2018-002608-15 | Ph 3 | completed | An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis |
| NCT04908475 results posted | M20-326 2020-005512-21 | Ph 4 | completed | Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy |
| NCT04306965 results posted | 13305 | Ph 2 | completed | Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab |
| NCT02425826 UNVEIL results posted | CC-10004-PSOR-012 | Ph 4 | completed | A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis. |
| NCT03624127 POETYK-PSO-1 results posted | IM011-046 2018-001926-25 | Ph 3 | completed | Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis |
| NCT03442088 results posted | 07-17-33 | Ph 2 | completed | Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast |
| NCT03611751 POETYK-PSO-2 results posted | IM011-047 2018-001925-24 | Ph 3 | completed | An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis |
| NCT03082729 VIP-A results posted | 826652 97509210 | Ph 4 | completed | Vascular Inflammation in Psoriasis - Apremilast |
| NCT03175549 results posted | U01AA025476 | Ph 2 | completed | Medication Development in Alcoholism: Apremilast Versus Placebo |
| NCT04590586 COMMUNITY results posted | COV-01 | Ph 3 | completed | Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients |
| NCT03521687 results posted | GCO 17-2386 | Ph 4 | completed | Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA) |
| NCT01194219 ESTEEM 1 results posted | CC-10004-PSOR-008 | Ph 3 | completed | Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis |
| NCT01232283 ESTEEM 2 results posted | CC-10004-PSOR-009 | Ph 3 | completed | Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. |
| NCT01690299 results posted | CC-10004-PSOR-010 2012-000859-14 | Ph 3 | completed | Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis |
| NCT04161456 APACCO | TMP-0517 | Ph 2 | completed | Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata |
| NCT03930186 results posted | CC-10004-PSOR-023 U1111-1230-7468, 20200062 | Ph 3 | completed | A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy |
| NCT03160248 APREMINUM | AP-CL-ECZ-PI-006539 | Ph 2 | completed | An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema |
| NCT04572997 APLANTUS results posted | 069-008. 2016-005122-11 | Ph 2 | completed | Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS) |
| NCT02307513 results posted | CC-10004-BCT-002 2014-002108-25 | Ph 3 | completed | A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease |
| NCT03239106 results posted | CIP-ApremilastCC-10004 | Ph 2 | completed | A Study Examining the Medication Apremilast as Treatment for Chronic Itch |
| NCT02802735 results posted | CC-10004-CP-033 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects |
Showing 50 of 78 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
APREMILAST FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.