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Ethinone (ETHISTERONE)

Phase 3 active Small molecule

Ethinone (generic name: ETHISTERONE) is a ethisterone drug. It is currently in Phase 3 development.

Ethinone works by binding to sex hormone-binding globulin, affecting the levels of sex hormones in the body.

Ethinone, also known as ethisterone, is a small molecule drug in the ethisterone class that targets sex hormone-binding globulin. It is not FDA-approved for any indications, and its commercial status, generic availability, and patent status are unknown. Ethinone works by binding to sex hormone-binding globulin, which affects the levels of sex hormones in the body. As a result, it may be used to treat conditions related to hormonal imbalances. However, due to its unknown status, its use and safety considerations are not well established.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameETHISTERONE
Drug classethisterone
TargetSex hormone-binding globulin, Glucocorticoid receptor, Androgen receptor
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 3

Mechanism of action

Think of sex hormone-binding globulin like a container that holds onto sex hormones in the body. Ethinone is like a key that fits into this container, changing how many sex hormones are available. This can affect how the body works, especially for people with hormonal imbalances.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Ethinone

What is Ethinone?

Ethinone (ETHISTERONE) is a ethisterone drug.

How does Ethinone work?

Ethinone works by binding to sex hormone-binding globulin, affecting the levels of sex hormones in the body.

What is the generic name of Ethinone?

ETHISTERONE is the generic (nonproprietary) name of Ethinone.

What drug class is Ethinone in?

Ethinone belongs to the ethisterone class. See all ethisterone drugs at /class/ethisterone.

What development phase is Ethinone in?

Ethinone is in Phase 3.

What does Ethinone target?

Ethinone targets Sex hormone-binding globulin, Glucocorticoid receptor, Androgen receptor and is a ethisterone.

Related

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