Last reviewed 2026-06-02 · How we verify

Open-label CBP-307

Connect Biopharm LLC · Phase 2 active Small molecule ✓ Verified Jun 2026

Open-label CBP-307 is a Small molecule drug developed by Connect Biopharm LLC. It is currently in Phase 2 development.

Open-label CBP-307 is being studied in a clinical trial for the treatment of moderate to severe ulcerative colitis. CBP-307 is a protein modality, also known as CBP 501, according to its entry in ChEMBL.

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	Open-label CBP-307
Sponsor	Connect Biopharm LLC
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) (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:

Open-label CBP-307 CI brief — competitive landscape report
Open-label CBP-307 updates RSS · CI watch RSS
Connect Biopharm LLC portfolio CI

Frequently asked questions about Open-label CBP-307

What is Open-label CBP-307?

Open-label CBP-307 is a Small molecule drug developed by Connect Biopharm LLC.

Who makes Open-label CBP-307?

Open-label CBP-307 is developed by Connect Biopharm LLC (see full Connect Biopharm LLC pipeline at /company/connect-biopharm-llc).

What development phase is Open-label CBP-307 in?

Open-label CBP-307 is in Phase 2.

Manufacturer: Connect Biopharm LLC — full pipeline

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