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Afloxan (PROGLUMETACIN)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 24/100

Afloxan (generic name: PROGLUMETACIN) is a proglumetacin drug. It is currently in Phase 2 development for Arthritis, Osteoarthritis, Rheumatoid arthritis.

Afloxan works by inhibiting the activity of enzymes called lipoxygenases, which play a role in the production of inflammatory mediators.

Afloxan is a small molecule with the synonyms PROGLUMETACIN, PROGLUMETACINA, and PROGLUMETACINE.

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 namePROGLUMETACIN
Drug classproglumetacin
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Think of it like a fire alarm system in your body. When you have an injury or infection, your body sends out chemical signals to alert the immune system to come and fight the problem. Afloxan helps to turn off these signals, reducing the amount of inflammation and pain in the affected area.

Approved indications

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:

Frequently asked questions about Afloxan

What is Afloxan?

Afloxan (PROGLUMETACIN) is a proglumetacin drug, indicated for Arthritis, Osteoarthritis, Rheumatoid arthritis.

How does Afloxan work?

Afloxan works by inhibiting the activity of enzymes called lipoxygenases, which play a role in the production of inflammatory mediators.

What is Afloxan used for?

Afloxan is indicated for Arthritis, Osteoarthritis, Rheumatoid arthritis.

What is the generic name of Afloxan?

PROGLUMETACIN is the generic (nonproprietary) name of Afloxan.

What drug class is Afloxan in?

Afloxan belongs to the proglumetacin class. See all proglumetacin drugs at /class/proglumetacin.

What development phase is Afloxan in?

Afloxan is in Phase 2.

Related

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