Last reviewed 2026-05-27 · How we verify

Amphisol (AMIPHENAZOLE)

Phase 2 active Small molecule ✓ Verified May 2026

Amphisol (generic name: AMIPHENAZOLE) is a drug. It is currently in Phase 2 development.

Amphisol is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.

Amphisol is a small molecule with synonyms including Amifenasol, Amiphénazol, and Amiphénazole.

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	AMIPHENAZOLE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine Amphisol as a key that fits into a lock on a cell. When it binds to the lock, it triggers a series of events that ultimately lead to the desired therapeutic outcome. This process can involve changes in the way cells communicate with each other or the way they respond to signals.

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:

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

Frequently asked questions about Amphisol

What is Amphisol?

Amphisol (AMIPHENAZOLE) is a Small molecule drug.

How does Amphisol work?

Amphisol is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.

What is the generic name of Amphisol?

AMIPHENAZOLE is the generic (nonproprietary) name of Amphisol.

What development phase is Amphisol in?

Amphisol is in Phase 2.

Therapeutic area: All drugs in Other

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