Last reviewed 2026-05-31 · How we verify

OXAFLUMAZINE

Phase 2 active Small molecule ✓ Verified May 2026

OXAFLUMAZINE is a drug. It is currently in Phase 2 development.

OXAFLUMAZINE is a small molecule that interacts with specific biological pathways to produce its effects.

OXAFLUMAZINE is a small molecule with the synonyms OXAFLUMAZINA, OXAFLUMAZINE, SD 270-31 FREE BASE, and SD-270-31 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	OXAFLUMAZINE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and OXAFLUMAZINE is a key that fits into one of those locks. When it binds to the lock, it can either turn it on or off, depending on the specific lock and the key's shape. This can help regulate various cellular processes, but the exact details of how OXAFLUMAZINE works are still unknown.

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:

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

Frequently asked questions about OXAFLUMAZINE

What is OXAFLUMAZINE?

OXAFLUMAZINE is a Small molecule drug.

How does OXAFLUMAZINE work?

OXAFLUMAZINE is a small molecule that interacts with specific biological pathways to produce its effects.

What development phase is OXAFLUMAZINE in?

OXAFLUMAZINE is in Phase 2.

Therapeutic area: All drugs in Other

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