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← All drugs Report issue

mavacamten

Trade name: Camzyos

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Apr 28, 2022

Clinical trial activity

26 trials · 8 clinical orgs · 2 marketing orgs

Phase 1
9
Phase 2
10
Phase 3
7
Phase 4
3

Earliest trial started Dec 1, 2014 (NCT02329184)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Apr 27, 2016

    Orphan Drug Designation

  4. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Apr 28, 2022

    Bristol-Myers Squibb — Earliest FDA Approval

  2. Apr 28, 2022

    Bristol-Myers — Marketing Organization

  3. Apr 28, 2022

    Bristol-Myers Squibb — NDA Secondary Org

  4. Apr 28, 2022

    Bristol-Myers Squibb — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughApr 28, 2022

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)n1c(=O)cc(N[C@@H](C)c2ccccc2)[nH]c1=O
Mol. weight
273.34 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

Black box warningFirst in class

Sources

Also known as

  • myk-461
  • myk-461

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07103655Phase 4Jan 1, 2026Zhejiang University
NCT07120776N/ASep 30, 2025University of Manchester
NCT07004972Phase 4Sep 4, 2025Bristol-Myers Squibb
NCT06947590N/AApr 20, 2025Jiao Tong University
NCT06856265N/AFeb 26, 2025Jiao Tong University
NCT06253221Phase 3Apr 17, 2024Bristol-Myers Squibb
NCT06211179Phase 1Jan 10, 2024Bristol-Myers Squibb
NCT06112743Phase 4Dec 30, 2023Bristol-Myers Squibb
NCT05719805Phase 1Feb 20, 2023Bristol-Myers Squibb
NCT05658146Phase 1Jan 5, 2023Bristol-Myers Squibb
NCT05582395Phase 3Oct 31, 2022Bristol-Myers Squibb
NCT05414175Phase 3Aug 19, 2022Bristol-Myers Squibb
NCT05362045Phase 1May 16, 2022Bristol-Myers Squibb
NCT05320094Phase 1Apr 15, 2022Bristol-Myers Squibb
NCT05174416Phase 3Jan 4, 2022Chinese Academy of Medical Sciences, LianBio LLC
NCT05135871Phase 1Oct 31, 2021Fudan University, LianBio LLC
NCT04766892Phase 2Mar 30, 2021MyoKardia, Inc.
NCT04349072Phase 3Sep 30, 2020MyoKardia, Inc.
NCT03723655Phase 2/Phase 3 (Phase 3)Oct 5, 2018MyoKardia, Inc.
NCT03470545Phase 3May 29, 2018MyoKardia, Inc.
Showing 20 of 26 trials
Page 1 / 2

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit101032022
MyoKardia, Inc.For profit101032014
Jiao Tong UniversityAcademic/Hospital2212025
LianBio LLCFor profit2222021
Chinese Academy of Medical SciencesAcademic/Hospital1012022
Fudan UniversityAcademic/Hospital1012021
University of ManchesterAcademic/Hospital1112025
Zhejiang UniversityAcademic/Hospital1112026
8 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Bristol-MyersFor profitMKTGApr 28, 2022
Bristol-Myers SquibbFor profitNDA2Apr 28, 2022
Bristol-Myers SquibbFor profitNDAApr 28, 2022