Last reviewed 2026-05-20 · How we verify

Oragalin (AZINTAMIDE)

Phase 2 active Small molecule

Oragalin (generic name: AZINTAMIDE) is a azintamide drug. It is currently in Phase 2 development.

Oragalin works by binding to a specific target, although its exact target is unknown.

Oragalin, also known as AZINTAMIDE, is a small molecule drug in the azintamide class. Its target and exact mechanism of action are unknown. It is not FDA approved for any indications. The commercial status of Oragalin is unclear, and it is not known whether it is patented or available as a generic. Further research is needed to determine its safety and efficacy.

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	AZINTAMIDE
Drug class	azintamide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Oragalin is a key that fits into one of those locks. When it binds to the lock, it can affect how the cell works, but we don't know exactly how it does that yet. This is a simplified explanation of how Oragalin might work, but more research is needed to understand its full effects.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

MITE in the Treatment of Dyspepsia After Cholecystectomy (PHASE4)

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial 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:

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

Frequently asked questions about Oragalin

What is Oragalin?

Oragalin (AZINTAMIDE) is a azintamide drug.

How does Oragalin work?

Oragalin works by binding to a specific target, although its exact target is unknown.

What is the generic name of Oragalin?

AZINTAMIDE is the generic (nonproprietary) name of Oragalin.

What drug class is Oragalin in?

Oragalin belongs to the azintamide class. See all azintamide drugs at /class/azintamide.

What development phase is Oragalin in?

Oragalin is in Phase 2.

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

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