Last reviewed 2026-05-30 · How we verify

Ro 24-5913 (CINALUKAST)

Phase 2 active Small molecule ✓ Verified May 2026

Ro 24-5913 (generic name: CINALUKAST) is a cinalukast drug. It is currently in Phase 2 development.

CINALUKAST works by blocking the cysteinyl leukotriene receptor 1, which plays a key role in the body's inflammatory response.

Ro 24-5913 is a small molecule with the synonyms CINALUKAST, CINALUKAST, RO 24-5913, RO-24-5913, and RO-245913.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	CINALUKAST
Drug class	cinalukast
Target	Cysteinyl leukotriene receptor 1, Cysteinyl leukotriene receptor 1
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body's immune system is like a fire alarm. When it senses an intruder, it sounds the alarm and sends out chemical signals to fight the invader. CINALUKAST helps to turn off the fire alarm by blocking the receptor that receives these chemical signals, reducing the body's inflammatory response.

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:

Ro 24-5913 CI brief — competitive landscape report
Ro 24-5913 updates RSS · CI watch RSS

Frequently asked questions about Ro 24-5913

What is Ro 24-5913?

Ro 24-5913 (CINALUKAST) is a cinalukast drug.

How does Ro 24-5913 work?

CINALUKAST works by blocking the cysteinyl leukotriene receptor 1, which plays a key role in the body's inflammatory response.

What is the generic name of Ro 24-5913?

CINALUKAST is the generic (nonproprietary) name of Ro 24-5913.

What drug class is Ro 24-5913 in?

Ro 24-5913 belongs to the cinalukast class. See all cinalukast drugs at /class/cinalukast.

What development phase is Ro 24-5913 in?

Ro 24-5913 is in Phase 2.

What does Ro 24-5913 target?

Ro 24-5913 targets Cysteinyl leukotriene receptor 1, Cysteinyl leukotriene receptor 1 and is a cinalukast.

Drug class: All cinalukast drugs
Target: All drugs targeting Cysteinyl leukotriene receptor 1, Cysteinyl leukotriene receptor 1
Therapeutic area: All drugs in Immunology

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