DANAZOL

Pre-Launch

danazol

Mthera Pharma

ANDAORALCAPSULE

Lifecycle

Pre-Launch

Clinical Trials

Data completeness

4/8 — Partial

DANAZOL (danazol) by Mthera Pharma is clinical pharmacology danazol suppresses the pituitary-ovarian axis. Approved for endometriosis amenable to hormonal management, attacks of angioedema of all types (cutaneous, abdominal and 2 more indications.

Drug data last refreshed 1mo ago

$0.0BPart D

Mechanism of Action

CLINICAL PHARMACOLOGY Danazol suppresses the pituitary-ovarian axis. This suppression is probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of sex steroid metabolism, and interaction of danazol with sex hormone receptors. The only…

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (2)

NCT04173494Phase 3Completed

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

Started Feb 2020

195 enrolled

Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis

NCT03352076Phase 2Completed

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy

Started Dec 2017

30 enrolled

Endometriosis

DANAZOL

Mechanism of Action

Indications (5)

Clinical Trials (2)