Last reviewed 2026-04-19 · How we verify

FEMJA transplatation

Hospices Civils de Lyon · Phase 1 active Biologic

FEMJA transplatation is a Biologic drug developed by Hospices Civils de Lyon. It is currently in Phase 1 development. Also known as: Cultivated oral mucosal epithelium transplantation.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	FEMJA transplatation
Also known as	Cultivated oral mucosal epithelium transplantation
Sponsor	Hospices Civils de Lyon
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency (PHASE1, PHASE2)

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:

FEMJA transplatation CI brief — competitive landscape report
FEMJA transplatation updates RSS · CI watch RSS
Hospices Civils de Lyon portfolio CI

Frequently asked questions about FEMJA transplatation

What is FEMJA transplatation?

FEMJA transplatation is a Biologic drug developed by Hospices Civils de Lyon.

Who makes FEMJA transplatation?

FEMJA transplatation is developed by Hospices Civils de Lyon (see full Hospices Civils de Lyon pipeline at /company/hospices-civils-de-lyon).

Is FEMJA transplatation also known as anything else?

FEMJA transplatation is also known as Cultivated oral mucosal epithelium transplantation.

What development phase is FEMJA transplatation in?

FEMJA transplatation is in Phase 1.

Manufacturer: Hospices Civils de Lyon — full pipeline
Also known as: Cultivated oral mucosal epithelium transplantation

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