Last reviewed 2026-05-27 · How we verify

RGB-5088

Hangzhou Reprogenix Bioscience, Inc · Phase 1 active Biologic ✓ Verified May 2026

RGB-5088 is a Biologic drug developed by Hangzhou Reprogenix Bioscience, Inc. It is currently in Phase 1 development.

RGB-5088 is a small molecule being studied in a Phase I clinical trial for its safety and efficacy in patients with Type 1 Diabetes Mellitus. The trial, identified as NCT06731218, is being conducted by Hangzhou Reprogenix Bioscience, Inc.

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	RGB-5088
Sponsor	Hangzhou Reprogenix Bioscience, Inc
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus (PHASE1)

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:

RGB-5088 CI brief — competitive landscape report
RGB-5088 updates RSS · CI watch RSS
Hangzhou Reprogenix Bioscience, Inc portfolio CI

Frequently asked questions about RGB-5088

What is RGB-5088?

RGB-5088 is a Biologic drug developed by Hangzhou Reprogenix Bioscience, Inc.

Who makes RGB-5088?

RGB-5088 is developed by Hangzhou Reprogenix Bioscience, Inc (see full Hangzhou Reprogenix Bioscience, Inc pipeline at /company/hangzhou-reprogenix-bioscience-inc).

What development phase is RGB-5088 in?

RGB-5088 is in Phase 1.

Manufacturer: Hangzhou Reprogenix Bioscience, Inc — full pipeline

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