Last reviewed 2026-05-23 · How we verify

Amikellin (KHELLIN)

Phase 2 active Small molecule ✓ Verified May 2026

Amikellin (generic name: KHELLIN) is a khellin drug. It is currently in Phase 2 development.

Khellin works by inhibiting the Cytochrome P450 1A1 enzyme, which plays a role in the metabolism of certain substances in the body.

Amikellin is a small molecule with the synonyms AMMIVIN, CORONIN, KELINA, KHELLIN, KHELLINE, and KHELLOYD.

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	KHELLIN
Drug class	khellin
Target	Cytochrome P450 1A1
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a traffic cop: the Cytochrome P450 1A1 enzyme helps control the flow of substances through the body's metabolic pathways. Khellin acts like a roadblock, slowing down this process and potentially affecting how certain substances are broken down or used by the body.

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:

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

Frequently asked questions about Amikellin

What is Amikellin?

Amikellin (KHELLIN) is a khellin drug.

How does Amikellin work?

Khellin works by inhibiting the Cytochrome P450 1A1 enzyme, which plays a role in the metabolism of certain substances in the body.

What is the generic name of Amikellin?

KHELLIN is the generic (nonproprietary) name of Amikellin.

What drug class is Amikellin in?

Amikellin belongs to the khellin class. See all khellin drugs at /class/khellin.

What development phase is Amikellin in?

Amikellin is in Phase 2.

What does Amikellin target?

Amikellin targets Cytochrome P450 1A1 and is a khellin.

Drug class: All khellin drugs
Target: All drugs targeting Cytochrome P450 1A1
Therapeutic area: All drugs in Metabolic

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