Last reviewed 2026-05-26 · How we verify

MORNIFLUMATE

Phase 2 active Small molecule ✓ Verified May 2026

MORNIFLUMATE is a morniflumate drug. It is currently in Phase 2 development.

Morniflumate is thought to work by inhibiting an enzyme involved in inflammation.

Morniflumate is a small molecule with the synonyms Morniflumate, Morniflumato, and Niflumic acid beta-morpholinoethyl ester.

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	MORNIFLUMATE
Drug class	morniflumate
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body's natural response to injury or infection is like a fire alarm that goes off to alert the immune system. Morniflumate may help reduce the noise of the fire alarm by blocking the enzyme that sends the signal, which could help reduce inflammation and alleviate symptoms.

Approved indications

No approved indications tracked.

Common side effects

Obstructive airways disorder
Benign prostatic hyperplasia
Full blood count abnormal
Congenital hiatus hernia
Wheezing
Chronic obstructive pulmonary disease
Scrotal infection
Perineal infection
Optic nerve operation
Pulmonary vasculitis
Respiratory symptom
Sleep disorder due to a general medical condition

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about MORNIFLUMATE

What is MORNIFLUMATE?

MORNIFLUMATE is a morniflumate drug.

How does MORNIFLUMATE work?

Morniflumate is thought to work by inhibiting an enzyme involved in inflammation.

What drug class is MORNIFLUMATE in?

MORNIFLUMATE belongs to the morniflumate class. See all morniflumate drugs at /class/morniflumate.

What development phase is MORNIFLUMATE in?

MORNIFLUMATE is in Phase 2.

What are the side effects of MORNIFLUMATE?

Common side effects of MORNIFLUMATE include Obstructive airways disorder, Benign prostatic hyperplasia, Full blood count abnormal, Congenital hiatus hernia, Wheezing, Chronic obstructive pulmonary disease.

Drug class: All morniflumate drugs
Therapeutic area: All drugs in Immunology

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