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Bay F 4975 (ACEMETACIN)

Phase 2 active Small molecule Under review Quality 0/100

Bay F 4975 (generic name: ACEMETACIN) is a acemetacin drug. It is currently in Phase 2 development for Ankylosing spondylitis, Rheumatism.

Acemetacin works by inhibiting the enzyme lactoylglutathione lyase, which is involved in the breakdown of certain inflammatory mediators.

Bay F 4975 is a small molecule inhibitor of the enzyme Cyclooxygenase. It is classified as a cyclooxygenase inhibitor, with synonyms including Acemetacin.

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 nameACEMETACIN
Drug classacemetacin
TargetLactoylglutathione lyase
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Think of it like a fire alarm in a burning building. The fire alarm (lactoylglutathione lyase) is triggered by the fire (inflammation), and it sends a signal to the firefighters (other enzymes) to come and put out the fire. Acemetacin blocks the fire alarm, so the firefighters don't get the signal, and the inflammation continues to burn.

Approved indications

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 Bay F 4975

What is Bay F 4975?

Bay F 4975 (ACEMETACIN) is a acemetacin drug, indicated for Ankylosing spondylitis, Rheumatism.

How does Bay F 4975 work?

Acemetacin works by inhibiting the enzyme lactoylglutathione lyase, which is involved in the breakdown of certain inflammatory mediators.

What is Bay F 4975 used for?

Bay F 4975 is indicated for Ankylosing spondylitis, Rheumatism.

What is the generic name of Bay F 4975?

ACEMETACIN is the generic (nonproprietary) name of Bay F 4975.

What drug class is Bay F 4975 in?

Bay F 4975 belongs to the acemetacin class. See all acemetacin drugs at /class/acemetacin.

What development phase is Bay F 4975 in?

Bay F 4975 is in Phase 2.

What are the side effects of Bay F 4975?

Common side effects of Bay F 4975 include Axial spondyloarthritis, Spinal osteoarthritis, Ankylosing spondylitis, Residual urine volume increased, Uveitis.

What does Bay F 4975 target?

Bay F 4975 targets Lactoylglutathione lyase and is a acemetacin.

Related

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