Last reviewed 2026-06-02 · How we verify

CPCB-RPE1

Regenerative Patch Technologies, LLC · Phase 1 active Biologic ✓ Verified Jun 2026

CPCB-RPE1 is a Biologic drug developed by Regenerative Patch Technologies, LLC. It is currently in Phase 1 development.

The CPCB-RPE1 implant is a treatment being studied for advanced Dry Age-related Macular Degeneration, specifically Geographic Atrophy, through a Phase IIb clinical trial. The implant is administered via surgical subretinal implantation.

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	CPCB-RPE1
Sponsor	Regenerative Patch Technologies, LLC
Modality	Biologic
Phase	Phase 1

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:

CPCB-RPE1 CI brief — competitive landscape report
CPCB-RPE1 updates RSS · CI watch RSS
Regenerative Patch Technologies, LLC portfolio CI

Frequently asked questions about CPCB-RPE1

What is CPCB-RPE1?

CPCB-RPE1 is a Biologic drug developed by Regenerative Patch Technologies, LLC.

Who makes CPCB-RPE1?

CPCB-RPE1 is developed by Regenerative Patch Technologies, LLC (see full Regenerative Patch Technologies, LLC pipeline at /company/regenerative-patch-technologies-llc).

What development phase is CPCB-RPE1 in?

CPCB-RPE1 is in Phase 1.

Manufacturer: Regenerative Patch Technologies, LLC — full pipeline

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