Last reviewed 2026-05-20 · How we verify

BUTALAMINE

Phase 2 active Small molecule ✓ Verified May 2026

BUTALAMINE is a butalamine drug. It is currently in Phase 2 development.

Butalamine is thought to work by interacting with a specific target in the body, although the exact nature of this interaction is not yet fully understood.

Butalamine is a small molecule with the synonyms butalamina, butalamine, butalamine, LA 1221 free base, and LA-1221 free base.

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	BUTALAMINE
Drug class	butalamine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine butalamine as a key that fits into a lock in the body. When it binds to its target, it can help to regulate various bodily functions, but the exact way it does this is still a mystery. More research is needed to understand how butalamine works and what effects it might have on the body.

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:

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

Frequently asked questions about BUTALAMINE

What is BUTALAMINE?

BUTALAMINE is a butalamine drug.

How does BUTALAMINE work?

Butalamine is thought to work by interacting with a specific target in the body, although the exact nature of this interaction is not yet fully understood.

What drug class is BUTALAMINE in?

BUTALAMINE belongs to the butalamine class. See all butalamine drugs at /class/butalamine.

What development phase is BUTALAMINE in?

BUTALAMINE is in Phase 2.

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

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