Last reviewed 2026-05-27 · How we verify

Clometacillin (CLOMETOCILLIN)

Phase 2 active Small molecule ✓ Verified May 2026

Clometacillin (generic name: CLOMETOCILLIN) is a clometocillin drug. It is currently in Phase 2 development.

Clometacillin works by binding to a specific target, although its exact mechanism of action is unknown.

Clometacillin is a small molecule antibiotic. It is also known by synonyms such as CLOMETOCILINA, CLOMETOCILLIN, and CLOMETOCILLINE.

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	CLOMETOCILLIN
Drug class	clometocillin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and each lock has a specific key that fits perfectly. Clometacillin is like a key that binds to a specific lock, but we don't know which lock it is or what it does when it binds. This binding can affect how cells work, but we need more research to understand the details.

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:

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

Frequently asked questions about Clometacillin

What is Clometacillin?

Clometacillin (CLOMETOCILLIN) is a clometocillin drug.

How does Clometacillin work?

Clometacillin works by binding to a specific target, although its exact mechanism of action is unknown.

What is the generic name of Clometacillin?

CLOMETOCILLIN is the generic (nonproprietary) name of Clometacillin.

What drug class is Clometacillin in?

Clometacillin belongs to the clometocillin class. See all clometocillin drugs at /class/clometocillin.

What development phase is Clometacillin in?

Clometacillin is in Phase 2.

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

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