Last reviewed 2026-05-29 · How we verify

Amolimogene

Eisai Inc. · Phase 2 active Small molecule ✓ Verified May 2026

Amolimogene is a Small molecule drug developed by Eisai Inc.. It is currently in Phase 2 development. Also known as: ZYC101a.

Amolimogene is a gene-based intervention being studied for the treatment of uterine cervical dysplasia. It is a synthetic gene that has been tested in a multi-center, double-blind, randomized, placebo-controlled study.

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	Amolimogene
Also known as	ZYC101a
Sponsor	Eisai Inc.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix (PHASE2, PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Amolimogene CI brief — competitive landscape report
Amolimogene updates RSS · CI watch RSS
Eisai Inc. portfolio CI

Frequently asked questions about Amolimogene

What is Amolimogene?

Amolimogene is a Small molecule drug developed by Eisai Inc..

Who makes Amolimogene?

Amolimogene is developed by Eisai Inc. (see full Eisai Inc. pipeline at /company/eisai).

Is Amolimogene also known as anything else?

Amolimogene is also known as ZYC101a.

What development phase is Amolimogene in?

Amolimogene is in Phase 2.

Manufacturer: Eisai Inc. — full pipeline
Therapeutic area: All drugs in Other
Also known as: ZYC101a

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