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Mavacamten Capsule 2
Mavacamten Capsule 2 is a Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 1 development. Also known as: BMS-986427, MYK-461.
Mavacamten Capsule 2 is used in clinical trials to study its effects on various conditions, including Hypertrophic Cardiomyopathy and Obstructive Hypertrophic Cardiomyopathy. The exact mechanism of Mavacamten Capsule 2 is not specified in the provided facts, but it is being studied in a bioequivalence trial to compare its effects to Mavacamten Capsule 1.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Mavacamten Capsule 2 |
|---|---|
| Also known as | BMS-986427, MYK-461 |
| Sponsor | Bristol-Myers Squibb |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM (PHASE2, PHASE3)
- Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects (PHASE1)
- A Study to Evaluate the Effects of Mavacamten in Healthy Participants (PHASE1)
- A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mavacamten Capsule 2 CI brief — competitive landscape report
- Mavacamten Capsule 2 updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Mavacamten Capsule 2
What is Mavacamten Capsule 2?
Who makes Mavacamten Capsule 2?
Is Mavacamten Capsule 2 also known as anything else?
What development phase is Mavacamten Capsule 2 in?
Related
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Also known as: BMS-986427, MYK-461
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing