Last reviewed 2026-04-20 · How we verify

Butethamate (BUTETAMATE)

Phase 2 active Small molecule

Butethamate (generic name: BUTETAMATE) is a butetamate drug. It is currently in Phase 2 development.

Butethamate is thought to work by interacting with a specific target in the body, although the exact mechanism is currently unknown.

Butethamate, also known as BUTETAMATE, is a small molecule drug in the butetamate class. Its original development is attributed to an unknown entity, and its current ownership is also unclear. The target of butetamate is currently unknown, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to fully understand the properties and potential applications of butetamate.

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	BUTETAMATE
Drug class	butetamate
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine butethamate as a key that fits into a lock in the body. When it binds to this lock, it can help to turn off or slow down certain processes that are involved in a disease. However, the exact details of how butethamate works are still being studied and are not yet fully understood.

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:

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

Frequently asked questions about Butethamate

What is Butethamate?

Butethamate (BUTETAMATE) is a butetamate drug.

How does Butethamate work?

Butethamate is thought to work by interacting with a specific target in the body, although the exact mechanism is currently unknown.

What is the generic name of Butethamate?

BUTETAMATE is the generic (nonproprietary) name of Butethamate.

What drug class is Butethamate in?

Butethamate belongs to the butetamate class. See all butetamate drugs at /class/butetamate.

What development phase is Butethamate in?

Butethamate is in Phase 2.

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

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