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apremilast

Trade name: otezla

Small moleculeapprovedOrphan Drug FDA

Approved

Mar 21, 2014

APREMILAST, (±)- is a mixture of isomers, one of them is therapeutic active S form (apremilast), an inhibitor of phosphodiesterase 4. This active form is sold under the brand name OTEZLA for the treatment of adult patients with active psoriatic arthritis. — NCATS

Clinical trial activity

127 trials · 104 clinical orgs · 18 marketing orgs

Phase 1
15
Phase 2
82
Phase 3
38
Phase 4
27

Earliest trial started Jan 1, 2005 (NCT00604682)

Timeline

2000s

  1. Jan 1, 2005

    Celgene — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Celgene — Earliest Phase 3 Sponsor(trial)

  2. Jan 17, 2013

    Orphan Drug Designation

  3. Mar 21, 2014

    Celgene — Earliest FDA Approval

  4. Mar 21, 2014

    Amgen — Marketing Organization

  5. Mar 21, 2014

    Celgene — NDA Organization

  6. Mar 21, 2014

    Amgen — NDA Secondary Org

  7. Apr 18, 2019

    Mankind Pharma — Marketing Organization

  8. Apr 18, 2019

    MannKind Corp — Marketing Organization

  9. Jun 24, 2019

    Hetero Labs Ltd — Marketing Organization

  10. Nov 15, 2019

    Dr. Reddy's Laboratories — Marketing Organization

  11. Nov 15, 2019

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Aug 21, 2020

    Ascend Laboratories Llc — Marketing Organization

  2. Feb 17, 2021

    Unichem — Marketing Organization

  3. Mar 4, 2021

    Shilpa Medicare Ltd. — Marketing Organization

  4. Jun 30, 2021

    Amneal Pharmaceuticals — Marketing Organization

  5. Sep 21, 2021

    Alkem Labs Ltd — Marketing Organization

  6. Aug 18, 2022

    Teva — Marketing Organization

  7. Jul 19, 2023

    Aurobindo Pharma — Marketing Organization

  8. Oct 16, 2023

    Glenmark Pharmaceuticals — Marketing Organization

  9. Nov 25, 2024

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  10. Dec 16, 2024

    MSN Laboratories — Marketing Organization

  11. Jun 20, 2025

    Torrent Pharmaceuticals Limited — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 21, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CCOC1=C(OC)C=CC(=C1)C(CS(C)(=O)=O)N2C(=O)C3=C(C2=O)C(NC(C)=O)=CC=C3
Mol. weight
460.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • apremilast
  • aprémilast
  • aprémilast
  • apremilastum
  • apremilastum
  • cc-100004
  • cc10004
  • cc10004
  • cc10004
  • cc 10004
  • cc-10004
  • cc-10004
  • cc-10004
  • cc-10004
  • cc-10004
  • n-{2-[(1s)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1h-isoindol-4-yl}acetamide
  • n-{2-[(1s)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1h-isoindol-4-yl}acetamide
  • otezla
  • otezla
  • otezla
  • otezla
  • otezla

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07029529Phase 2Nov 30, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), Yale University
NCT06863493Phase 2/Phase 3 (Phase 3)Jun 1, 2025SFA Therapeutics
NCT06509984Phase 2Nov 1, 2024University of Nice Sophia Antipolis
NCT06593197Phase 4Sep 30, 2024Dow University of Health Sciences
NCT06588738Phase 3Aug 20, 2024Alumis Inc
NCT06586112Phase 3Jul 25, 2024Alumis Inc
NCT06324435Phase 1May 8, 2024National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Research on Women's Health (ORWH), Yale University
NCT06260904Phase 4Feb 26, 2024All India Institute of Medical Sciences
NCT06122649Phase 3Nov 27, 2023Amgen
NCT06108544Phase 3Nov 6, 2023Takeda
NCT06088043Phase 3Nov 6, 2023Takeda
NCT06088199Phase 3Oct 24, 2023Amgen
NCT05767047Phase 3Mar 23, 2023Amgen
NCT05565560Phase 3Feb 28, 2023Amgen
NCT06084663Phase 3Feb 15, 2023Humanis Saglık Anonim Sirketi
NCT05601492Early Phase 1 (Phase 1)Jan 31, 2023Amgen, Wake Forest University
NCT05926882Phase 4Aug 1, 2022Jinnah Postgraduate Medical Centre, University of Karachi
NCT05174065Phase 3Mar 8, 2022Amgen
NCT06032858Phase 4Mar 6, 2022Ghurki Trust and Teaching Hospital
NCT05875714Phase 2Jan 13, 2022University of Pennsylvania
Showing 20 of 127 trials
Page 1 / 7

Organizations

Research & Development (104)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CelgeneFor profit744052005
AmgenFor profit10832020
Bristol-Myers SquibbFor profit3312018
Derm Research, PLLCFor profit3312016
Icahn School of Medicine at Mount SinaiAcademic/Hospital3332016
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government3022017
University of PennsylvaniaAcademic/Hospital3222017
Yale UniversityAcademic/Hospital3222020
Alumis IncFor profit2212024
Case Western Reserve UniversityAcademic/Hospital2212008
Columbia UniversityAcademic/Hospital2112010
J. W. Goethe UniversityAcademic/Hospital2112009
New York UniversityAcademic/Hospital2112008
Oregon Health and Science UniversityAcademic/Hospital2222009
Stanford UniversityAcademic/Hospital2222010
TakedaFor profit2212023
Tufts UniversityAcademic/Hospital2212009
United States ArmyGovernment2212008
University of Alabama, BirminghamAcademic/Hospital2122017
University of CopenhagenAcademic/Hospital2222017
104 organizations
Page 1 / 6

Marketing (22)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGSep 21, 2021
AmgenFor profitMKTGMar 21, 2014
AmgenFor profitNDA2Mar 21, 2014
Amneal PharmaceuticalsFor profitMKTGJun 30, 2021
Ascend Laboratories LlcFor profitMKTGAug 21, 2020
Aurobindo PharmaFor profitMKTGJul 19, 2023
CelgeneFor profitNDAMar 21, 2014
Dr. Reddy's LaboratoriesFor profitMKTGNov 15, 2019
Dr. Reddy's LaboratoriesFor profitSYNJul 14, 2023
Glenmark PharmaceuticalsFor profitMKTGOct 16, 2023
Hetero Labs LtdFor profitMKTGJun 24, 2019
MSN LaboratoriesFor profitMKTGDec 16, 2024
Macleods Pharmaceuticals, LtdFor profitMKTGNov 25, 2024
Mankind PharmaFor profitMKTGApr 18, 2019
MannKind CorpFor profitMKTGApr 18, 2019
Shilpa Medicare Ltd.For profitMKTGMar 4, 2021
Shilpa Medicare Ltd.For profitSYNApr 7, 2023
TevaFor profitMKTGAug 18, 2022
Torrent Pharmaceuticals LimitedFor profitMKTGJun 20, 2025
UnichemFor profitMKTGFeb 17, 2021
Zydus Discovery DMCCFor profitMKTGNov 15, 2019
Zydus Discovery DMCCFor profitSYNSep 21, 2021