Danazol for endometriosis
Danazol is an approved small molecule for endometriosis whose annotated mechanism of action is androgen receptor agonism.
Hypothesized mechanism
Danazol acts as an androgen receptor agonist, which may contribute to its therapeutic effect in endometriosis.
This is the model’s proposed mechanism from the sources on file, not a demonstrated causal pathway. How well the published record supports it is reflected in the rigor and plausibility dimensions of the score, and traced to the verbatim sources at the foot of the page.
How the score was reached, for this pair
The composite score is the sum of five dimensions, each scored 0 to 2 by the model from the evidence on file. Below is the sub-score this specific pair received on each, with what that dimension measures. It scored 3.8 of 10 overall, a emerging reading, from a pathway rated emerging in strength.
The model’s overall reasoning for this pair is the summary at the top of the page, and the mechanism it proposed is in the section above.
Scored for women. Female representation not stated — applicability to women uncertain (flagged for full text). (band F4, ×0.75).
Corroboration
Only a single mechanistic line is provided — the Open Targets annotation that danazol acts as an androgen receptor agonist. No independent converging lines of evidence (e.g., gonadotropin suppression, anti-inflammatory effects) are cited.
Rigor
The claim is a curated database annotation (Open Targets) linking an approved drug to endometriosis, not an experimental model. It reflects human-relevant clinical/regulatory context (APPROVAL stage) but provides no mechanistic study data.
Specificity
The single claim names a specific drug action on a specific target: danazol as an androgen receptor agonist on the androgen receptor. The target-action relationship is explicitly stated.
Plausibility
Androgen receptor agonism is a plausible mechanism for endometriosis given danazol's known clinical use, and the drug reached APPROVAL stage. However, the claim does not link AR agonism to an endometriosis-relevant phenotype mechanistically beyond the database association.
Consistency
With only one claim there is no contradiction, but also no multiple signals to confirm directional agreement. The single annotation is internally consistent but cannot demonstrate convergence.
Regulatory & development status
Where this candidate sits in the US regulatory landscape: whether the drug is already FDA-approved for endometriosis (on-label) or approved for something else (off-label), whether the molecule is available as a generic or a single-source brand still under patent, and how far it has been studied as a therapy for this condition. Each fact is drawn from a public US source and reported beside the score; none of it is folded into the score.
This is descriptive context, not regulatory advice. It maps the landscape a 505(b)(2)route would build on (an already-approved active ingredient proposed for a new indication), but it is not a 505(b)(2) viability assessment, and says nothing about whether any particular development path is advisable. “Approved” means FDA-approved (US); approvals elsewhere are out of scope.
Approval relationship On-label (FDA-approved for this use)
Read from the drug’s FDA label via DailyMed, the US National Library of Medicine’s label repository. A label is only counted when it carries an FDA-approved marketing category (an NDA, ANDA, or biologic BLA); dietary supplements, homeopathics, and OTC-monograph products are not FDA-approved drugs and are excluded.
For this pair. This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.
From the label’s Indications & Usage section: “"2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> INDICATIONS AND USAGE Endometriosis Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal managemen”, DANAZOL CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · view label ↗
Generic & patent supply Generic available
Read from the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), using single-ingredient products only so that patents on novel branded combination formulations are never attributed to the base molecule.
For this molecule. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).
Clinical-trial stage, for this condition Phase 3
Read from ClinicalTrials.gov (US National Library of Medicine). A trial only counts when the drug appears as an experimental or active-comparator intervention in an interventional study of this condition; mechanistic, drug-interaction, post-marketing (Phase 4), and comparator-background uses are excluded, so this reflects the drug being tested as a therapy for endometriosis.
For this pair. Studied in 4 qualifying interventional trials · highest stage reached Phase 3 · completed.
Layers not covered for this pair
Not covered for this pair. This layer holds documented sex-specific pharmacokinetics for a limited set of drugs, and this compound is not among them yet. A blank here means the drug is not covered by the layer, not that no sex difference exists.
More on the sex-specific pharmacokinetics layer and its sources →Not covered for this pair. The cycle-phase layer is seeded for the strongest-evidence cases so far (PMDD), and this pair is not among them yet. A blank here means the pair is not covered by the layer, not that the effect was found to be phase-independent.
More on the cycle-phase layer and its sources →Source evidence · what the pipeline ingested
These are the sources the pipeline ingested to detect and score this signal, the published literature the model actually read, each tagged by study type. Where the model combined findings the claim is marked as a synthesis (S), and where the literature disagrees the contradiction is shown (!).
Every source below belongs to this signal’s evidence arm, Pathway insights. Whel reads each drug-condition pair through four such arms, each held to its own inclusion bar; a signal is surfaced through one of them.
- 1Per Open Targets (retrieved 2026-06-16), DANAZOL (a Small molecule) is a clinical candidate for endometriosis (maximum clinical stage APPROVAL); its mechanism of action is Androgen Receptor agonist on target androgen receptor. Open Targets · mechanistic ↗
- 2In FDA AEMS (the FDA Adverse Event Reporting System, formerly FAERS; retrieved 2026-06-16), 34 report(s) of ABDOMINAL PAIN were recorded for DANAZOL among female patients (of 1249 female reports for DANAZOL in the analysed sample). This is a raw adverse-event report count, not a disproportionality statistic or evidence of causation, and is subject to reporting bias and confounding. Read two ways: as a safety consideration, and — because it suggests DANAZOL acts on a system relevant to endometriosis — as a mechanistic lead for further investigation, not evidence of benefit. AEMS · adverse-event report ↗
- 3In FDA AEMS (the FDA Adverse Event Reporting System, formerly FAERS; retrieved 2026-06-16), 21 report(s) of ABDOMINAL DISTENSION were recorded for DANAZOL among female patients (of 1249 female reports for DANAZOL in the analysed sample). This is a raw adverse-event report count, not a disproportionality statistic or evidence of causation, and is subject to reporting bias and confounding. Read two ways: as a safety consideration, and — because it suggests DANAZOL acts on a system relevant to endometriosis — as a mechanistic lead for further investigation, not evidence of benefit. AEMS · adverse-event report ↗
These are the verbatim sources the pipeline surfaced and read; they may not be the full published record for a pair, and the score reflects the strength and agreement of the evidence rather than its volume. The strength of these source types is what the rigor dimension of the score reads off. MATRIX, sex-specific pharmacokinetics, and cycle phase are separate layers the pipeline does not ingest, external cross-references reported beside the score, and they link to their own sources in their sections above.
The primary sources and pipelines this evidence is drawn from →