Last reviewed 2026-04-20 · How we verify

LINSIDOMINE

Phase 2 active Small molecule Quality 24/100

LINSIDOMINE is a linsidomine drug. It is currently in Phase 2 development.

Linsidomine works by releasing nitric oxide, which helps to relax blood vessels and improve blood flow.

Linsidomine is a small molecule drug in the linsidomine class, but its target and exact mechanism of action are unknown. It is not clear if it is FDA-approved or commercially available. The drug's pharmacokinetic properties, such as half-life and bioavailability, are also unknown. Linsidomine's approved indications and generic status are not specified. Further research is needed to understand its clinical use and safety profile.

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	LINSIDOMINE
Drug class	linsidomine
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Think of it like a key that unlocks the blood vessels, allowing them to relax and widen. This helps to improve blood flow and can be beneficial for people with certain medical conditions. By releasing nitric oxide, linsidomine can help to reduce blood pressure and improve overall cardiovascular health.

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:

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

Frequently asked questions about LINSIDOMINE

What is LINSIDOMINE?

LINSIDOMINE is a linsidomine drug.

How does LINSIDOMINE work?

Linsidomine works by releasing nitric oxide, which helps to relax blood vessels and improve blood flow.

What drug class is LINSIDOMINE in?

LINSIDOMINE belongs to the linsidomine class. See all linsidomine drugs at /class/linsidomine.

What development phase is LINSIDOMINE in?

LINSIDOMINE is in Phase 2.

Drug class: All linsidomine drugs
Therapeutic area: All drugs in Hematology

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