Last reviewed 2026-05-30 · How we verify

CETAMOLOL

Phase 2 active Small molecule ✓ Verified May 2026

CETAMOLOL is a cetamolol drug. It is currently in Phase 2 development.

CETAMOLOL is a small molecule that works by interacting with a specific target in the body, but its exact mechanism is unknown.

Cetamolol is a small molecule. It is also known by synonyms such as AI-27,303, AI-27303, CETAMOLOL HCL, CETAMOLOL HYDROCHLORIDE, and CETAMOLOL HYDROCHLORIDE.

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	CETAMOLOL
Drug class	cetamolol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and CETAMOLOL is a key that fits into one of those locks. When it binds to the lock, it can either turn the lock open or closed, depending on the type of lock and the key's shape. However, since the target of CETAMOLOL is unknown, we can't say exactly how it works or what kind of lock it fits into.

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:

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

Frequently asked questions about CETAMOLOL

What is CETAMOLOL?

CETAMOLOL is a cetamolol drug.

How does CETAMOLOL work?

CETAMOLOL is a small molecule that works by interacting with a specific target in the body, but its exact mechanism is unknown.

What drug class is CETAMOLOL in?

CETAMOLOL belongs to the cetamolol class. See all cetamolol drugs at /class/cetamolol.

What development phase is CETAMOLOL in?

CETAMOLOL is in Phase 2.

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

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