Last reviewed 2026-04-20 · How we verify

Butamiverine (BUTAVERINE)

Phase 2 active Small molecule

Butamiverine (generic name: BUTAVERINE) is a butaverine drug. It is currently in Phase 2 development.

Butamiverine works by interacting with muscarinic acetylcholine receptors in the body.

Butamiverine, also known as butaverine, is a small molecule drug in the butaverine class. Its exact target and mechanism of action are unknown, but it is believed to work by affecting the muscarinic acetylcholine receptors. Butamiverine is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to determine its safety and efficacy. As a result, butamiverine is not a widely recognized or used medication.

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 name	BUTAVERINE
Drug class	butaverine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Butamiverine is like a key that fits into a specific lock on the surface of cells, called muscarinic acetylcholine receptors. When it fits in, it can affect how the cell responds to signals, which can help with certain medical conditions.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Butamiverine CI brief — competitive landscape report
Butamiverine updates RSS · CI watch RSS

Frequently asked questions about Butamiverine

What is Butamiverine?

Butamiverine (BUTAVERINE) is a butaverine drug.

How does Butamiverine work?

Butamiverine works by interacting with muscarinic acetylcholine receptors in the body.

What is the generic name of Butamiverine?

BUTAVERINE is the generic (nonproprietary) name of Butamiverine.

What drug class is Butamiverine in?

Butamiverine belongs to the butaverine class. See all butaverine drugs at /class/butaverine.

What development phase is Butamiverine in?

Butamiverine is in Phase 2.

Drug class: All butaverine drugs
Therapeutic area: All drugs in Other

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