Telomelysin

Weill Medical College of Cornell University · Phase 2 active Small molecule

Telomelysin is a Small molecule drug developed by Weill Medical College of Cornell University. It is currently in Phase 2 development. Also known as: OBP-301.

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	Telomelysin
Also known as	OBP-301
Sponsor	Weill Medical College of Cornell University
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

• Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery (PHASE1)
• Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma (PHASE2)
• Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease (PHASE2)
• Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma (PHASE2)
• A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer (PHASE1)
• Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma (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:

• Telomelysin CI brief — competitive landscape report
• Telomelysin updates RSS · CI watch RSS
• Weill Medical College of Cornell University portfolio CI

Frequently asked questions about Telomelysin

What is Telomelysin?

Telomelysin is a Small molecule drug developed by Weill Medical College of Cornell University.

Who makes Telomelysin?

Telomelysin is developed by Weill Medical College of Cornell University (see full Weill Medical College of Cornell University pipeline at /company/weill-medical-college-of-cornell-university).

Is Telomelysin also known as anything else?

Telomelysin is also known as OBP-301.

What development phase is Telomelysin in?

Telomelysin is in Phase 2.

Related

• Manufacturer: Weill Medical College of Cornell University — full pipeline
• Therapeutic area: All drugs in Other
• Also known as: OBP-301