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Danazol Once Weekly
Danazol Once Weekly is a Aromatase inhibitor Small molecule drug developed by Lumara Health, Inc.. It is currently in Phase 2 development for Endometriosis, Fibrocystic breast disease.
Androgen receptor antagonist
Danazol Once Weekly is a small molecule that acts as a progesterone receptor agonist, classified as an agonist. It has been studied as a treatment for endometriosis, with a clinical trial (NCT00758953) completed in 2012 to evaluate its efficacy in this condition.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 name | Danazol Once Weekly |
|---|---|
| Sponsor | Lumara Health, Inc. |
| Drug class | Aromatase inhibitor |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Danazol acts by binding to the androgen receptor, thereby inhibiting the transcription of androgen-dependent genes.
Approved indications
- Endometriosis
- Fibrocystic breast disease
Common side effects
- Nausea
- Vomiting
- Headache
Key clinical trials
- Pain Associated With Endometriosis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- Danazol Once Weekly CI brief — competitive landscape report
- Danazol Once Weekly updates RSS · CI watch RSS
- Lumara Health, Inc. portfolio CI
Frequently asked questions about Danazol Once Weekly
What is Danazol Once Weekly?
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What is Danazol Once Weekly used for?
Who makes Danazol Once Weekly?
What drug class is Danazol Once Weekly in?
What development phase is Danazol Once Weekly in?
What are the side effects of Danazol Once Weekly?
What does Danazol Once Weekly target?
Related
- Drug class: All Aromatase inhibitor drugs
- Target: All drugs targeting Androgen receptor
- Manufacturer: Lumara Health, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Endometriosis
- Indication: Drugs for Fibrocystic breast disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing