Last reviewed 2026-04-20 · How we verify

Imiclopazin (IMICLOPAZINE)

Phase 2 active Small molecule

Imiclopazin (generic name: IMICLOPAZINE) is a imiclopazine drug. It is currently in Phase 2 development.

Imiclopazin is thought to work by interacting with a specific target in the brain, although the exact nature of this interaction is not well understood.

Imiclopazin (IMICLOPAZINE) is a small molecule drug in the imiclopazine class, but its target and exact mechanism of action are unknown. It is not FDA-approved for any indications. The commercial status of Imiclopazin is unclear, and it may be patented or off-patent. As a result, there is limited information available on its safety profile, pharmacokinetics, or generic manufacturers. Further research is needed to understand the potential benefits and risks of Imiclopazin.

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	IMICLOPAZINE
Drug class	imiclopazine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your brain is a city with many different neighborhoods. Imiclopazin is like a special key that unlocks a specific door in one of those neighborhoods, allowing it to communicate with other parts of the city in a unique way. This can help to regulate various bodily functions, but the exact details of how it works are still being studied.

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:

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

Frequently asked questions about Imiclopazin

What is Imiclopazin?

Imiclopazin (IMICLOPAZINE) is a imiclopazine drug.

How does Imiclopazin work?

Imiclopazin is thought to work by interacting with a specific target in the brain, although the exact nature of this interaction is not well understood.

What is the generic name of Imiclopazin?

IMICLOPAZINE is the generic (nonproprietary) name of Imiclopazin.

What drug class is Imiclopazin in?

Imiclopazin belongs to the imiclopazine class. See all imiclopazine drugs at /class/imiclopazine.

What development phase is Imiclopazin in?

Imiclopazin is in Phase 2.

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

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