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Niflamol (NIFLUMIC ACID)

Phase 2 active Small molecule ✓ Verified May 2026

Niflamol (generic name: NIFLUMIC ACID) is a niflumic acid drug. It is currently in Phase 2 development.

Niflumic acid works by blocking potassium channels to reduce inflammation.

Niflamol is a small molecule medication. It is also known by other names, including Niflumic acid, Niflumatic acid, and Niflumatico.

Likelihood of approval
12.3% 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).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
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 nameNIFLUMIC ACID
Drug classniflumic acid
TargetChloride channel protein ClC-Ka, Chloride channel protein ClC-Kb, Potassium channel subfamily T member 2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your body's cells are like a fire station, and inflammation is like a fire. Potassium channels help control the flow of information between cells, but when they're overactive, it's like the fire alarm is going off too much. Niflumic acid helps calm down the potassium channels, reducing the inflammation and 'fire' in the body.

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Niflamol

What is Niflamol?

Niflamol (NIFLUMIC ACID) is a niflumic acid drug.

How does Niflamol work?

Niflumic acid works by blocking potassium channels to reduce inflammation.

What is the generic name of Niflamol?

NIFLUMIC ACID is the generic (nonproprietary) name of Niflamol.

What drug class is Niflamol in?

Niflamol belongs to the niflumic acid class. See all niflumic acid drugs at /class/niflumic-acid.

What development phase is Niflamol in?

Niflamol is in Phase 2.

What are the side effects of Niflamol?

Common side effects of Niflamol include Aspirin-exacerbated respiratory disease.

What does Niflamol target?

Niflamol targets Chloride channel protein ClC-Ka, Chloride channel protein ClC-Kb, Potassium channel subfamily T member 2 and is a niflumic acid.

Related

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