CDEK
← All drugs Report issue

daridorexant

Trade name: Quviviq

Small moleculeapproved

Approved

Jan 7, 2022

Clinical trial activity

40 trials · 22 clinical orgs · 1 marketing orgs

Phase 1
24
Phase 2
12
Phase 3
5
Phase 4
4

Earliest trial started Feb 1, 2015 (NCT02919319)

Timeline

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Idorsia Pharmaceuticals Ltd. — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 7, 2022

    Idorsia Pharmaceuticals Ltd. — Earliest FDA Approval

  2. Jan 7, 2022

    Idorsia Pharmaceuticals Ltd. — Marketing Organization

  3. Jan 7, 2022

    Idorsia Pharmaceuticals Ltd. — NDA Secondary Org

  4. Jan 7, 2022

    Idorsia Pharmaceuticals Ltd. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 7, 2022

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Mol. weight
450.93 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

Sources

Also known as

  • act-541468
  • act-541468

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07136415Phase 4Dec 1, 2025Harvard University, Henry Ford Health System, Patient-Centered Outcomes Research Institute, University of Pittsburgh, University of Utah, Wake Forest University
NCT07217912Phase 2Oct 20, 2025University of Rochester
NCT07213349Phase 2Oct 7, 2025McGill University, Weston Foundation
NCT07267559Phase 4Oct 1, 2025University of Oxford
NCT07028697Phase 3Dec 4, 2024Nxera Pharma Korea Co., Ltd.
NCT06630390Phase 2Nov 1, 2024University of Rochester
NCT05948540Phase 2Nov 2, 2023Berry Consultants, Cambridge Cognition Ltd, Citeline, Idorsia Pharmaceuticals Ltd., PPD, United States Army
NCT06326723Phase 1Sep 4, 2023Nanjing University, Simcere Pharmaceutical Co., Ltd
NCT06010693Phase 3Aug 28, 2023Capital Medical University, Simcere Pharmaceutical Co., Ltd
NCT05924425Phase 4Jul 1, 2023Idorsia Pharmaceuticals Ltd., University of Montpellier
NCT05877222Phase 1Jun 23, 2023Idorsia Pharmaceuticals Ltd.
NCT05702177Phase 1Jan 5, 2023Idorsia Pharmaceuticals Ltd.
NCT05597020Phase 4Dec 15, 2022Idorsia Pharmaceuticals Ltd.
NCT05632393Phase 1Nov 30, 2022Idorsia Pharmaceuticals Ltd.
NCT05480475Phase 1Sep 3, 2022Idorsia Pharmaceuticals Ltd.
NCT05480488Phase 1Aug 23, 2022Idorsia Pharmaceuticals Ltd.
NCT05458193Phase 1Aug 17, 2022Idorsia Pharmaceuticals Ltd.
NCT05423717Phase 2Aug 9, 2022Idorsia Pharmaceuticals Ltd.
NCT04390334Phase 1May 26, 2020Idorsia Pharmaceuticals Ltd.
NCT04250506Phase 1Feb 7, 2020Idorsia Pharmaceuticals Ltd.
Showing 20 of 40 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Idorsia Pharmaceuticals Ltd.For profit252342017
ActelionFor profit7722015
Simcere Pharmaceutical Co., LtdFor profit2222023
University of RochesterAcademic/Hospital2212024
Berry ConsultantsFor profit1012023
Cambridge Cognition LtdFor profit1012023
Capital Medical UniversityAcademic/Hospital1012023
CitelineFor profit1012023
Harvard UniversityAcademic/Hospital1112025
Henry Ford Health SystemAcademic/Hospital1012025
McGill UniversityAcademic/Hospital1112025
Nanjing UniversityAcademic/Hospital1012023
Nxera Pharma Korea Co., Ltd.For profit1112024
Patient-Centered Outcomes Research InstituteAcademic/Hospital1012025
PPDFor profit1012023
United States ArmyGovernment1112023
University of MontpellierAcademic/Hospital1112023
University of OxfordAcademic/Hospital1112025
University of PittsburghAcademic/Hospital1012025
University of UtahAcademic/Hospital1012025
22 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
Idorsia Pharmaceuticals Ltd.For profitMKTGJan 7, 2022
Idorsia Pharmaceuticals Ltd.For profitSYNJan 7, 2022
Idorsia Pharmaceuticals Ltd.For profitNDA2Jan 7, 2022
Idorsia Pharmaceuticals Ltd.For profitNDAJan 7, 2022