CBLB502

BioLab 612 LLC · Phase 2 active Small molecule

CBLB502 is a Small molecule drug developed by BioLab 612 LLC. It is currently in Phase 2 development. Also known as: Entolimod.

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	CBLB502
Also known as	Entolimod
Sponsor	BioLab 612 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

• Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination (PHASE2)
• Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery (PHASE1)
• Entolimod, an Adjuvant for Vaccine Augmentation (EARLY_PHASE1)
• Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer (PHASE2)
• Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy (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:

• CBLB502 CI brief — competitive landscape report
• CBLB502 updates RSS · CI watch RSS
• BioLab 612 LLC portfolio CI

Frequently asked questions about CBLB502

What is CBLB502?

CBLB502 is a Small molecule drug developed by BioLab 612 LLC.

Who makes CBLB502?

CBLB502 is developed by BioLab 612 LLC (see full BioLab 612 LLC pipeline at /company/biolab-612-llc).

Is CBLB502 also known as anything else?

CBLB502 is also known as Entolimod.

What development phase is CBLB502 in?

CBLB502 is in Phase 2.

Related

• Manufacturer: BioLab 612 LLC — full pipeline
• Also known as: Entolimod