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OXABOLONE CIPIONATE

Phase 2 active Small molecule ✓ Verified May 2026

OXABOLONE CIPIONATE is a oxabolone cipionate drug. It is currently in Phase 2 development.

Oxabolone cipionate is thought to work by interacting with a specific biological target, but its exact mechanism of action is not well understood.

Oxabolone cipionate is a small molecule medication. It is also known by several other names, including Cipionate d'oxabolone, Cipionato de oxabolona, and FI 5852.

Likelihood of approval
15.3% 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).
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 nameOXABOLONE CIPIONATE
Drug classoxabolone cipionate
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells have locks on them, and oxabolone cipionate is a key that fits into one of those locks. When it binds to the lock, it can either turn the lock on or off, depending on the type of lock and the key's shape. This can affect how cells behave and communicate with each other.

Approved indications

No approved indications tracked.

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 OXABOLONE CIPIONATE

What is OXABOLONE CIPIONATE?

OXABOLONE CIPIONATE is a oxabolone cipionate drug.

How does OXABOLONE CIPIONATE work?

Oxabolone cipionate is thought to work by interacting with a specific biological target, but its exact mechanism of action is not well understood.

What drug class is OXABOLONE CIPIONATE in?

OXABOLONE CIPIONATE belongs to the oxabolone cipionate class. See all oxabolone cipionate drugs at /class/oxabolone-cipionate.

What development phase is OXABOLONE CIPIONATE in?

OXABOLONE CIPIONATE is in Phase 2.

Related

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