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16Beta-Ethyl-19-Nortestosterone (OXENDOLONE)

Phase 2 active Small molecule

16Beta-Ethyl-19-Nortestosterone (generic name: OXENDOLONE) is a oxendolone drug. It is currently in Phase 2 development.

OXENDOLONE works by binding to androgen receptors in the body, triggering a cascade of events that promote muscle growth and development.

16Beta-Ethyl-19-Nortestosterone (OXENDOLONE) is a synthetic anabolic steroid classified under the oxendolone drug class. It is a small molecule modality, but its commercial status and approved indications are unknown. As a synthetic anabolic steroid, OXENDOLONE is believed to work by mimicking the effects of testosterone in the body, promoting muscle growth and development. However, its exact mechanism of action and key safety considerations are not well-documented. Further research is needed to fully understand the properties and effects of OXENDOLONE.

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 nameOXENDOLONE
Drug classoxendolone
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body has a 'building plan' for muscle growth, and androgen receptors are like the blueprints. When OXENDOLONE binds to these receptors, it essentially gives the body a 'boost' to follow the plan, leading to increased muscle mass and strength.

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 16Beta-Ethyl-19-Nortestosterone

What is 16Beta-Ethyl-19-Nortestosterone?

16Beta-Ethyl-19-Nortestosterone (OXENDOLONE) is a oxendolone drug.

How does 16Beta-Ethyl-19-Nortestosterone work?

OXENDOLONE works by binding to androgen receptors in the body, triggering a cascade of events that promote muscle growth and development.

What is the generic name of 16Beta-Ethyl-19-Nortestosterone?

OXENDOLONE is the generic (nonproprietary) name of 16Beta-Ethyl-19-Nortestosterone.

What drug class is 16Beta-Ethyl-19-Nortestosterone in?

16Beta-Ethyl-19-Nortestosterone belongs to the oxendolone class. See all oxendolone drugs at /class/oxendolone.

What development phase is 16Beta-Ethyl-19-Nortestosterone in?

16Beta-Ethyl-19-Nortestosterone is in Phase 2.

Related

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