Last reviewed 2026-05-26 · How we verify

Clotepin (CLOROTEPINE)

Phase 2 active Small molecule ✓ Verified May 2026

Clotepin (generic name: CLOROTEPINE) is a clorotepine drug. It is currently in Phase 2 development.

Clorotepine works by blocking the histamine H1 receptor, which helps regulate various physiological processes.

Clotepin is a small molecule. It is also known by the synonyms Clorotepina, Clorotepine, and Clothepin.

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	CLOROTEPINE
Drug class	clorotepine
Target	5-hydroxytryptamine receptor 6, D(4) dopamine receptor, 5-hydroxytryptamine receptor 2C
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has a system that helps you feel alert and awake, and another system that helps you relax and sleep. Histamine is a chemical that helps control these systems. Clorotepine blocks the histamine H1 receptor, which helps regulate these systems and can lead to a calming effect.

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:

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

Frequently asked questions about Clotepin

What is Clotepin?

Clotepin (CLOROTEPINE) is a clorotepine drug.

How does Clotepin work?

Clorotepine works by blocking the histamine H1 receptor, which helps regulate various physiological processes.

What is the generic name of Clotepin?

CLOROTEPINE is the generic (nonproprietary) name of Clotepin.

What drug class is Clotepin in?

Clotepin belongs to the clorotepine class. See all clorotepine drugs at /class/clorotepine.

What development phase is Clotepin in?

Clotepin is in Phase 2.

What does Clotepin target?

Clotepin targets 5-hydroxytryptamine receptor 6, D(4) dopamine receptor, 5-hydroxytryptamine receptor 2C and is a clorotepine.

Drug class: All clorotepine drugs
Target: All drugs targeting 5-hydroxytryptamine receptor 6, D(4) dopamine receptor, 5-hydroxytryptamine receptor 2C
Therapeutic area: All drugs in Other

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