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roflumilast

Trade name: daliresp

Small moleculeapproved

Approved

Feb 28, 2011

Roflumilast is a specific phosphodiesterase type (4PDE4) inhibitor indicated for use as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. — NCATS

Clinical trial activity

119 trials · 79 clinical orgs · 16 marketing orgs

Phase 1
21
Phase 2
83
Phase 3
41
Phase 4
15

Earliest trial started Jan 1, 2003 (NCT00430729)

Timeline

2000s

  1. Jan 1, 2003

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2004

    AstraZeneca — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2004

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

2010s

  1. Feb 28, 2011

    Forest Laboratories — Earliest FDA Approval

  2. Feb 28, 2011

    AstraZeneca — Marketing Organization

  3. Feb 28, 2011

    Forest Laboratories — NDA Organization

  4. Feb 28, 2011

    AstraZeneca — NDA Secondary Org

  5. May 31, 2016

    Strides Pharma Science — Marketing Organization

  6. May 30, 2018

    MSN Laboratories — Marketing Organization

  7. Jul 13, 2018

    Mylan — Marketing Organization

  8. Jul 13, 2018

    PHARMOBEDIENT — Marketing Organization

  9. Aug 6, 2018

    Torrent Pharmaceuticals Limited — Marketing Organization

  10. Oct 3, 2018

    Esteve Labs — Marketing Organization

  11. Oct 3, 2018

    Senores Pharms — Marketing Organization

  12. Nov 23, 2018

    Hetero Labs Ltd — Marketing Organization

  13. Mar 22, 2019

    Micro Labs Ltd India — Marketing Organization

2020s

  1. Jul 20, 2021

    Alkem Labs Ltd — Marketing Organization

  2. Feb 10, 2022

    Zydus Discovery DMCC — Marketing Organization

  3. May 10, 2022

    Prinston Inc — Marketing Organization

  4. Jul 29, 2022

    Arcutis, Inc. — Marketing Organization

  5. Jul 29, 2022

    Arcutis, Inc. — NDA Secondary Org

  6. Apr 17, 2023

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 28, 2011

Chemistry & pharmacology

Loading structure…

SMILES

FC(F)OC1=CC=C(C=C1OCC2CC2)C(=O)NC3=C(Cl)C=NC=C3Cl
Mol. weight
403.207 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

First in class

Sources

Also known as

  • 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide
  • b9302-107
  • b9302-107
  • b9302-107
  • by217
  • by-217
  • by-217
  • byk20869
  • byk-20869
  • byk-20869
  • daliresp
  • daliresp
  • daliresp
  • daliresp
  • daliresp
  • daliresp
  • daxas
  • daxas
  • daxas
  • libertek
  • libertek
  • libertek
  • libertek
  • libertek
  • rof
  • rof
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilast
  • roflumilastum
  • roflumilastum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07263230Phase 2Apr 1, 2026Harvard University
NCT07297602Phase 2Nov 20, 2025Mansoura University
NCT07077902Phase 2Sep 30, 2025Arcutis, Inc., Tulane University
NCT07233291Phase 2Aug 20, 2025—
NCT07105254Phase 2Aug 1, 2025Arcutis, Inc., Derm Texas, PLLC
NCT06998056Phase 2Jun 9, 2025Arcutis, Inc.
NCT06860958Phase 3Mar 20, 2025Tanta University
NCT07174011Phase 4Jan 12, 2025Cairo University
NCT06648772Phase 3Nov 26, 2024Hangzhou Zhongmei
NCT06631170Phase 3Nov 20, 2024Hangzhou Zhongmei
NCT06457191Phase 1Nov 6, 2024University of Calgary
NCT06440473Phase 4May 28, 2024Rao Dermatology
NCT05796271Phase 1Jan 31, 2024University of Texas, San Antonio
NCT05682859Phase 4Sep 25, 2023Novo Nordisk, University of Copenhagen
NCT05884281Phase 1/Phase 2 (Phase 2)Jul 31, 2023Mansoura University
NCT05684484Phase 4Feb 1, 2023Tanta University
NCT05684744Phase 2/Phase 3 (Phase 3)Jan 9, 2023Cairo University
NCT05418049Early Phase 1 (Phase 1)Sep 1, 2022National Institutes of Health (NIH), University of Cincinnati
NCT05369793Phase 3Aug 1, 2022Tanta University
NCT05369039Phase 2Jun 30, 2022Menoufia University
Showing 20 of 119 trials
Page 1 / 6

Organizations

Research & Development (79)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit343442003
Arcutis, Inc.For profit232132017
Tanta UniversityAcademic/Hospital6632021
Mitsubishi TanabeFor profit4012004
Cairo UniversityAcademic/Hospital3332021
ChiesiFor profit3222012
Johns Hopkins UniversityAcademic/Hospital3332013
Maastricht UniversityAcademic/Hospital3312011
TakedaFor profit3122012
University of Texas, San AntonioAcademic/Hospital3312013
FLUIDDA nvFor profit2222011
Forest LaboratoriesFor profit2022013
FougeraFor profit2012008
Hangzhou ZhongmeiFor profit2212024
Mansoura UniversityAcademic/Hospital2112023
National Heart, Lung, and Blood Institute (NHLBI)Government2112013
The University of Hong KongAcademic/Hospital2212018
University of AntwerpAcademic/Hospital2022011
University of CalgaryAcademic/Hospital2212020
University of CincinnatiAcademic/Hospital2222013
79 organizations
Page 1 / 4

Marketing (21)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGJul 20, 2021
Arcutis, Inc.For profitMKTGJul 29, 2022
Arcutis, Inc.For profitNDA2Jul 29, 2022
AstraZenecaFor profitMKTGFeb 28, 2011
AstraZenecaFor profitNDA2Feb 28, 2011
Aurobindo PharmaFor profitMKTGApr 17, 2023
Esteve LabsFor profitSYNOct 3, 2018
Esteve LabsFor profitMKTGOct 3, 2018
Forest LaboratoriesFor profitNDAFeb 28, 2011
Hetero Labs LtdFor profitMKTGNov 23, 2018
MSN LaboratoriesFor profitMKTGMay 30, 2018
MSN LaboratoriesFor profitSYNSep 7, 2022
Micro Labs Ltd IndiaFor profitMKTGMar 22, 2019
MylanFor profitMKTGJul 13, 2018
MylanFor profitSYNJul 13, 2018
PHARMOBEDIENTFor profitMKTGJul 13, 2018
Prinston IncFor profitMKTGMay 10, 2022
Senores PharmsFor profitMKTGOct 3, 2018
Strides Pharma ScienceFor profitMKTGMay 31, 2016
Torrent Pharmaceuticals LimitedFor profitMKTGAug 6, 2018
Zydus Discovery DMCCFor profitMKTGFeb 10, 2022