Last reviewed · How we verify

Butamyrate (BUTAMIRATE)

Phase 2 active Small molecule ✓ Verified May 2026

Butamyrate (generic name: BUTAMIRATE) is a butamirate drug. It is currently in Phase 2 development.

Butamirate is thought to work by interacting with a specific target in the body, although its exact mechanism of action is unknown.

Butamirate is a small molecule. It is also known by the synonyms butamirate, butamirate, butamirate, butamirato, and codimin.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameBUTAMIRATE
Drug classbutamirate
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine butamirate as a key that fits into a lock in the body. When it binds to this lock, it can affect how the body works, but we don't yet know exactly how it does this or what it does to help with a particular condition.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Butamyrate

What is Butamyrate?

Butamyrate (BUTAMIRATE) is a butamirate drug.

How does Butamyrate work?

Butamirate is thought to work by interacting with a specific target in the body, although its exact mechanism of action is unknown.

What is the generic name of Butamyrate?

BUTAMIRATE is the generic (nonproprietary) name of Butamyrate.

What drug class is Butamyrate in?

Butamyrate belongs to the butamirate class. See all butamirate drugs at /class/butamirate.

What development phase is Butamyrate in?

Butamyrate is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing