Last reviewed 2026-05-19 · How we verify

[14C]-BVD-523

BioMed Valley Discoveries, Inc · Phase 1 active Small molecule ✓ Verified May 2026

[14C]-BVD-523 is a Small molecule drug developed by BioMed Valley Discoveries, Inc. It is currently in Phase 1 development. Also known as: Ulixertinib.

BVD-523, also known as Ulixertinib, is a small molecule inhibitor that targets the mitogen-activated protein kinase 3 (MAPK3) pathway. Specifically, it acts as a MAP kinase ERK1 inhibitor, which is a class of drugs that inhibit the ERK1 enzyme.

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	[14C]-BVD-523
Also known as	Ulixertinib
Sponsor	BioMed Valley Discoveries, Inc
Modality	Small molecule
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:

[14C]-BVD-523 CI brief — competitive landscape report
[14C]-BVD-523 updates RSS · CI watch RSS
BioMed Valley Discoveries, Inc portfolio CI

Frequently asked questions about [14C]-BVD-523

What is [14C]-BVD-523?

[14C]-BVD-523 is a Small molecule drug developed by BioMed Valley Discoveries, Inc.

Who makes [14C]-BVD-523?

[14C]-BVD-523 is developed by BioMed Valley Discoveries, Inc (see full BioMed Valley Discoveries, Inc pipeline at /company/biomed-valley-discoveries-inc).

Is [14C]-BVD-523 also known as anything else?

[14C]-BVD-523 is also known as Ulixertinib.

What development phase is [14C]-BVD-523 in?

[14C]-BVD-523 is in Phase 1.

Manufacturer: BioMed Valley Discoveries, Inc — full pipeline
Also known as: Ulixertinib

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