Last reviewed 2026-05-15 · How we verify

Muntelukast

Assaf-Harofeh Medical Center · Phase 3 active Small molecule

Muntelukast is a Small molecule drug developed by Assaf-Harofeh Medical Center. It is currently in Phase 3 development. Also known as: Singulair.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Muntelukast
Also known as	Singulair
Sponsor	Assaf-Harofeh Medical Center
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study (PHASE3)

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:

Muntelukast CI brief — competitive landscape report
Muntelukast updates RSS · CI watch RSS
Assaf-Harofeh Medical Center portfolio CI

Frequently asked questions about Muntelukast

What is Muntelukast?

Muntelukast is a Small molecule drug developed by Assaf-Harofeh Medical Center.

Who makes Muntelukast?

Muntelukast is developed by Assaf-Harofeh Medical Center (see full Assaf-Harofeh Medical Center pipeline at /company/assaf-harofeh-medical-center).

Is Muntelukast also known as anything else?

Muntelukast is also known as Singulair.

What development phase is Muntelukast in?

Muntelukast is in Phase 3.

Manufacturer: Assaf-Harofeh Medical Center — full pipeline
Therapeutic area: All drugs in Other
Also known as: Singulair

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