Last reviewed 2026-06-03 · How we verify

BIDISOMIDE

Phase 2 active Small molecule ✓ Verified Jun 2026

BIDISOMIDE is a bidisomide drug. It is currently in Phase 2 development.

BIDISOMIDE works by binding to a specific target, but its exact mechanism of action is unknown.

BIDISOMIDE is a small molecule with the synonyms BIDISOMIDA, BIDISOMIDE, BIDISOMIDE, SC 40230, and SC-40230.

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	BIDISOMIDE
Drug class	bidisomide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and BIDISOMIDE has a key that fits into one of those locks. When it binds, it can either turn the lock to open the cell or block the lock to prevent something from entering. However, the exact lock and key relationship for BIDISOMIDE is still a mystery.

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:

BIDISOMIDE CI brief — competitive landscape report
BIDISOMIDE updates RSS · CI watch RSS

Frequently asked questions about BIDISOMIDE

What is BIDISOMIDE?

BIDISOMIDE is a bidisomide drug.

How does BIDISOMIDE work?

BIDISOMIDE works by binding to a specific target, but its exact mechanism of action is unknown.

What drug class is BIDISOMIDE in?

BIDISOMIDE belongs to the bidisomide class. See all bidisomide drugs at /class/bidisomide.

What development phase is BIDISOMIDE in?

BIDISOMIDE is in Phase 2.

Drug class: All bidisomide drugs
Therapeutic area: All drugs in Other

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