Last reviewed 2026-05-26 · How we verify

Avinar (UREDEPA)

Phase 2 active Small molecule ✓ Verified May 2026

Avinar (generic name: UREDEPA) is a uredepa drug. It is currently in Phase 2 development.

Avinar works by interacting with a specific molecular target to produce a therapeutic effect.

Avinar is a small molecule with the synonyms AB-100, NSC-37095, UREDEPA, and UREDEPA.

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	UREDEPA
Drug class	uredepa
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Avinar is a key that fits into those locks. When Avinar binds to its target, it helps to regulate the activity of the cells, which can help to treat certain medical conditions. This process is like a complex chemical handshake that helps to restore balance to the body's systems.

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:

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

Frequently asked questions about Avinar

What is Avinar?

Avinar (UREDEPA) is a uredepa drug.

How does Avinar work?

Avinar works by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Avinar?

UREDEPA is the generic (nonproprietary) name of Avinar.

What drug class is Avinar in?

Avinar belongs to the uredepa class. See all uredepa drugs at /class/uredepa.

What development phase is Avinar in?

Avinar is in Phase 2.

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

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