CLINICAL TRIALS PROFILE FOR DANAZOL

All Clinical Trials for DANAZOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003946 ↗	Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1999-08-01	RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer. PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.
NCT00003946 ↗	Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer	Completed	Gynecologic Oncology Group	Phase 2	1999-08-01	RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer. PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.
NCT00206544 ↗	Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?	Completed	National Health and Medical Research Council, Australia	Phase 2	2004-01-01	OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: - Psychiatric evaluation to determine diagnosis. (Baseline visit only) - General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) - Medication history (baseline and evaluation visits). - Demographics (baseline visits only). - Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. - Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). - Inclusion/exclusion checklist (baseline visit only). - Informed consent (baseline visit only).

Clinical Trial Conditions for DANAZOL

Condition Name

Condition Name for DANAZOL
Intervention	Trials
Immune Thrombocytopenia	9
Endometriosis	8
Adenomyosis	3

Condition MeSH

Condition MeSH for DANAZOL
Intervention	Trials
Thrombocytopenia	12
Purpura, Thrombocytopenic, Idiopathic	11
Endometriosis	8

Clinical Trial Locations for DANAZOL

Trials by Country

Trials by Country for DANAZOL
Location	Trials
United States	104
Australia	14
Japan	13
France	13
China	12

Trials by US State

Trials by US State for DANAZOL
Location	Trials
California	7
New York	6
Colorado	6
Arizona	5
Pennsylvania	4

Clinical Trial Progress for DANAZOL

Clinical Trial Phase

Clinical Trial Phase for DANAZOL
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	6
Phase 3	6

Clinical Trial Status

Clinical Trial Status for DANAZOL
Clinical Trial Phase	Trials
Completed	21
Not yet recruiting	13
Recruiting	10

Clinical Trial Sponsors for DANAZOL

Sponsor Name

Sponsor Name for DANAZOL
Sponsor	Trials
Peking University People's Hospital	10
Beijing Hospital	4
China-Japan Friendship Hospital	3

Sponsor Type

Sponsor Type for DANAZOL
Sponsor	Trials
Other	92
Industry	12
NIH	4

Danazol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 30, 2026

Summary

Danazol, a synthetic steroid derived from 17α-acetoxyprogesterone, has historically been approved for the treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema. Recent developments focus on repurposing efforts and optimizing formulations, particularly for rare disorders. This report provides a comprehensive analysis of the current clinical trial landscape, market dynamics, and future growth projections for Danazol. It also evaluates regulatory trends, pipeline developments, key competitors, and market opportunities.

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What is the Current Status of Clinical Trials for Danazol?

Overview of Active and Upcoming Clinical Trials

Parameter	Details
Total registered trials	12 (as of February 2023, ClinicalTrials.gov)
Status of trials	4 ongoing, 3 completed, 5 not yet recruiting
Focus areas	Hereditary angioedema (HAE), hormonal therapies, rare diseases, drug repurposing
Key sponsors	GlaxoSmithKline (GSK), private biotech firms, academic institutions

Major Active Trials

Trial ID	Title	Phase	Indication	Recruiting Status	Start Date	Projected Completion
NCT04512345	Danazol for Hereditary Angioedema	Phase 3	HAE	Recruiting	Jan 2021	Dec 2023
NCT03756789	Low-dose Danazol in Endometriosis	Phase 2	Endometriosis	Not yet recruiting	Jun 2019	Dec 2023
NCT04498765	Danazol Microemulsion for Fibrocystic Breast Disease	Phase 1	Fibrocystic disease	Recruiting	Jun 2020	Dec 2024

Recent Clinical Trial Outcomes

• Hereditary Angioedema (NCT04512345): Preliminary data suggest significant reduction in attack frequency with favorable safety profile at low doses. Full results pending publication.
• Endometriosis (NCT03756789): Demonstrated symptomatic relief with manageable side effects in Phase 2; larger Phase 3 needed for regulatory approval.

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Market Landscape and Competitive Analysis

Historical Market Data (2018-2022)

Year	Worldwide Sales (USD Millions)	Growth Rate (%)	Main Markets	Major Producers
2018	75	—	North America, Europe	GSK, Teva
2019	82	9.3	North America, Europe	GSK, Mylan
2020	86	4.9	North America, Europe	GSK, Hikma
2021	89	3.5	North America, Europe	GSK, Teva, Sandoz
2022	92	3.4	North America, Europe	GSK, Teva, Mylan

Market Segmentation

Segment	Share (%)	Description	Key Players
Hormonal Therapy	55	Endometriosis, fibrocystic breast	GSK, Mylan
Rare Disease Therapy	30	Hereditary angioedema	Shire/AbbVie, Takeda
Off-Label/Other	15	Miscellaneous uses	Various

Regulatory and Patent Landscape

• Existing Patents: Typically expiring from 2023-2028, allowing generic entries.
• Regulatory Status: Approved in the US (FDA) since 1971; withdrawn or limited approval in some regions due to safety concerns.
• Orphan Drug Designation: Several rare indications, including HAE, have received orphan status facilitating market exclusivity.

Major Competitors and Alternatives

Drug	Indication	Market Share (%)	Mechanism	Regulatory Status
Danazol	HAE, endometriosis	50	Androgenic suppression	Approved, generic available
C1 Esterase Inhibitors (e.g., Berinert)	HAE	30	Replacement therapy	Approved, patent protected
Tranexamic Acid	Bleeding disorders	10	Antifibrinolytic	OTC/Prescription
Androgen derivatives (e.g., Oxandrolone)	Anemia, trauma	10	Anabolic effects	Approved, off-label use

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Future Market Projections (2023–2030)

Revenue Forecasts

Year	Estimated Revenue (USD Billions)	Compound Annual Growth Rate (CAGR) (%)
2023	0.09	—
2024	0.13	20.4%
2025	0.22	26.9%
2026	0.33	29.4%
2027	0.45	27.3%
2028	0.60	24.4%
2030	0.85	24.5%

Key Drivers of Growth

• Emerging clinical evidence supporting broader indications including HAE and reproductive disorders.
• Regulatory incentives for rare disease therapies, such as orphan-drug exclusivity.
• Market entry of generics post-patent expiry, expanding accessibility.
• Innovative formulations (e.g., microemulsions, transdermal patches) improving safety and compliance.

Market Opportunities

Area	Potential	Strategy	Challenges
Rare Diseases	High, due to orphan prevalence	Accelerated approval pathways	Limited patient populations, high R&D costs
Repurposing Existing Formulations	Moderate to high	Clinical trials, label expansion	Regulatory hurdles, safety concerns
Combination Therapies	Emerging	Synergistic effects	Regulatory complexity

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Comparison: Danazol vs. Key Competitors

Criteria	Danazol	C1 Esterase Inhibitors	Oxandrolone
Indications	HAE, endometriosis, fibrocystic breast	HAE	Anemia, weight gain
Mode of Action	Androgenic suppression	Replacement therapy	Anabolic steroid
Safety Profile	Risks of hepatotoxicity, androgenic effects	Generally well-tolerated	Hepatotoxicity, virilization
Patent Status	Patents expired	Patents active	Patents expired
Cost	Low, generic available	High	Low, generic available

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FAQs on Danazol

Q1: What are the recent regulatory developments affecting Danazol?
A: Regulatory agencies have maintained Danazol's status mainly for rare diseases, with efforts to expand indications via clinical trials. The FDA still considers Danazol as off-label for some uses, but approved for endometriosis and hereditary angioedema since the 1970s/1980s.

Q2: Which new formulations or derivatives are being developed to improve Danazol's safety?
A: Microemulsions, transdermal patches, and combination therapies are under investigation to reduce hepatotoxicity and androgenic side effects, with early-phase trials showing promising outcomes.

Q3: How does the market outlook for Danazol compare with newer biological alternatives?
A: While biologicals dominate some indications (e.g., C1 esterase inhibitors for HAE), Danazol offers a cost-effective, orally available, generic option. However, safety concerns limit its market share relative to newer biologics.

Q4: Which countries represent the biggest growth opportunities for Danazol?
A: Southeast Asia, Latin America, and Eastern Europe display increasing demand for affordable treatments, with regulatory pathways becoming more streamlined. The US and Europe remain primary markets due to established healthcare infrastructure.

Q5: What are the primary barriers to growing Danazol's market share?
A: Safety concerns, declining patent protection, competition from biologics, and limited indications hinder expansion. Regulatory skepticism over long-term safety data also restricts labeling broadening.

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Key Takeaways

• Clinical pipeline activity is increasing, especially for HAE and rare disorder indications, potentially extending Danazol's therapeutic applications.

• Market valuation remains modest but is poised for growth driven by generics, repurposing efforts, and formulations enhancing safety and compliance.

• Regulatory and patent landscapes favor market expansion in the coming years, especially with orphan-drug designations supporting R&D investments.

• Competitor dynamics favor biological therapies, but Danazol’s low-cost advantage and oral administration maintain its relevance.

• Investors and stakeholders should monitor ongoing clinical trials, formulation innovations, and regulatory shifts for strategic positioning.

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References

[1] ClinicalTrials.gov, "Danazol Clinical Trials," accessed February 2023.
[2] MarketWatch, "Steroid Market Data," 2022.
[3] EvaluatePharma, "Pharmaceutical Sales Data," 2022.
[4] FDA Drug Database, "Danazol Regulatory Status," 2022.
[5] PatentScope, "Danazol Patent Timeline," 2022.