Last reviewed 2026-05-31 · How we verify

Idrobutamine (BUTIDRINE)

Phase 2 active Small molecule ✓ Verified May 2026

Idrobutamine (generic name: BUTIDRINE) is a butidrine drug. It is currently in Phase 2 development.

Butidrine is thought to work by interacting with a specific cellular target to produce a therapeutic effect.

Idrobutamine, also known as butidrine hydrochloride, is a small molecule 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	BUTIDRINE
Drug class	butidrine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Butidrine is a key that fits into one of those locks. When it binds to the lock, it triggers a series of events that ultimately lead to the desired therapeutic effect. However, the exact lock and key mechanism of Butidrine is 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:

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

Frequently asked questions about Idrobutamine

What is Idrobutamine?

Idrobutamine (BUTIDRINE) is a butidrine drug.

How does Idrobutamine work?

Butidrine is thought to work by interacting with a specific cellular target to produce a therapeutic effect.

What is the generic name of Idrobutamine?

BUTIDRINE is the generic (nonproprietary) name of Idrobutamine.

What drug class is Idrobutamine in?

Idrobutamine belongs to the butidrine class. See all butidrine drugs at /class/butidrine.

What development phase is Idrobutamine in?

Idrobutamine is in Phase 2.

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

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