CDEK
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lenacapavir

Trade name: Sunlenca

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Dec 22, 2022

Clinical trial activity

28 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
4
Phase 2
16
Phase 3
12
Phase 4
2

Earliest trial started Nov 26, 2018 (NCT03739866)

Timeline

2010s

  1. Jan 1, 2018

    Gilead Sciences — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2019

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2021

    Gilead Sciences — Earliest Phase 3 Sponsor(trial)

  2. Dec 22, 2022

    Gilead Sciences — Earliest FDA Approval

  3. Dec 22, 2022

    Gilead Sciences — Marketing Organization

  4. Dec 22, 2022

    Gilead Sciences — NDA Secondary Org

  5. Dec 22, 2022

    Gilead Sciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughDec 22, 2022

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C#Cc1ccc(-c2ccc(Cl)c3c(NS(C)(=O)=O)nn(CC(F)(F)F)c23)c([C@H](Cc2cc(F)cc(F)c2)NC(=O)Cn2nc(C(F)(F)F)c3c2C(F)(F)[C@@H]2C[C@H]32)n1)S(C)(=O)=O
Mol. weight
968.3 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

First in class

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07218211Phase 4Jan 5, 2026Duke University, Gilead Sciences
NCT07210125Phase 4Sep 16, 2025Gilead Sciences, Kelley-Ross & Associates, Inc.
NCT07047716Phase 3Jul 22, 2025Gilead Sciences
NCT06970223Phase 1Apr 22, 2025ViiV Healthcare
NCT06904183Phase 2Apr 1, 2025Anqing Municipal Hospital, First People's Hospital of Foshan, Guangdong Medical University, Guangzhou Medical University, Huizhou People's Central Hospital, Jieyang People's Hospital, Xiamen University
NCT06914375N/AMar 28, 2025Florida State University, United States Department of Agriculture
NCT06819176Phase 1Mar 20, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT06749054Phase 2Jan 31, 2025Gilead Sciences
NCT06532656Phase 2/Phase 3 (Phase 3)Nov 30, 2024Gilead Sciences
NCT06613685Phase 2/Phase 3 (Phase 3)Oct 21, 2024Gilead Sciences
NCT06630286Phase 3Oct 9, 2024Gilead Sciences
NCT06630299Phase 3Oct 8, 2024Gilead Sciences
NCT06513312Phase 2Oct 7, 2024Gilead Sciences
NCT06544733Phase 2/Phase 3 (Phase 3)Aug 20, 2024Gilead Sciences
NCT06492395Phase 3Aug 1, 2024Guangzhou Medical University
NCT06333808Phase 3Mar 25, 2024Gilead Sciences
NCT06364007Phase 2Mar 3, 2024Central South University
NCT06101342Phase 2Dec 13, 2023Gilead Sciences, HIV Prevention Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA)
NCT06101329Phase 2Nov 17, 2023Gilead Sciences, HIV Prevention Trials Network
NCT05729568Phase 2May 15, 2023Gilead Sciences
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit222042018
Guangzhou Medical UniversityAcademic/Hospital2222024
HIV Prevention Trials NetworkAcademic/Hospital2012023
National Institute of Allergy and Infectious Diseases (NIAID)Government2122023
Anqing Municipal HospitalAcademic/Hospital1012025
Central South UniversityAcademic/Hospital1112024
Duke UniversityAcademic/Hospital1112026
First People's Hospital of FoshanAcademic/Hospital1012025
Florida State UniversityAcademic/Hospital1112025
Guangdong Medical UniversityAcademic/Hospital1012025
Huizhou People's Central HospitalAcademic/Hospital1012025
Jieyang People's HospitalAcademic/Hospital1012025
Kelley-Ross & Associates, Inc.Academic/Hospital1112025
MerckFor profit1012021
National Institute on Drug Abuse (NIDA)Government1012023
United States Department of AgricultureGovernment1012025
ViiV HealthcareFor profit1112025
Xiamen UniversityAcademic/Hospital1012025
18 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitMKTGDec 22, 2022
Gilead SciencesFor profitNDA2Dec 22, 2022
Gilead SciencesFor profitNDADec 22, 2022