Danocrine

(Danazol)

ApprovedSmall molecule

Danazol is used to treat endometriosis (a painful condition where tissue grows outside the uterus), fibrocystic breast disease, and hereditary angioedema (a rare condition causing sudden swelling). It works by suppressing certain hormones in the body.[2] Danocrine is currently approved and in use across 11 indications[4].[1]

Danocrine is one of 228 small molecule programs targeting Breast Fibrocystic Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

227

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Breast Fibrocystic DiseaseActive, not recruiting

Aplastic AnemiaApproved

MastodyniaApproved

Ovarian ReserveActive, not recruiting

MenorrhagiaActive, not recruiting

Myelodysplastic SyndromeApproved

Breast CancerApproved

Fanconi AnemiaApproved

Autoimmune Thrombocytopenic PurpuraApproved

EndometriosisCompleted

Breast Fibrocystic DiseaseApproved

Active, not recruiting

Aplastic AnemiaApproved

Approved

MastodyniaApproved

Approved

Ovarian ReservePreclinical

Active, not recruiting

MenorrhagiaApproved

Active, not recruiting

Myelodysplastic SyndromeApproved

Approved

Breast CancerApproved

Approved

Fanconi AnemiaApproved

Approved

Autoimmune Thrombocytopenic PurpuraApproved

Approved

EndometriosisApproved

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Danocrine

Sanofi

Approved

31 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Duragesic-100

CCephalon

Preclinical

2 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Spravato

WWim Janssens

Preclinical

2 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Beta-Thalassemia

NCT07884773

Clinical

Trials by Indication[1]

Immune Thrombocytopenia9 trials

The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT06176911·124 enrolled

The Combination of Terbutaline and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT04481282·40 enrolled

The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05281068·120 enrolled

Show 6 more trials

The Combination of Sitagliptin and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05353673·120 enrolled

The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 1/2·NCT03460808·200 enrolled

Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05852847·216 enrolled

The Combination of ATRA and Danazol as Second-line Treatment in Adult Immune Thrombocytopenia

Completed·PPeking University People's Hospital·Phase 2·NCT01667263·130 enrolled

The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05494307·228 enrolled

The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05471050·120 enrolled

Endometriosis5 trials

Letrozole vs Danazol for Endometriosis-Related Pain: Randomized Trial

Completed·SSidra Salman·Phase 2·NCT07183787·60 enrolled

Danazol Treatment in Endometriosis Women Before IVF

Completed·CCentre for Endocrinology and Reproductive Medicine, Italy·Phase 4·NCT01779232·150 enrolled

Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

Unknown status·FFar Eastern Memorial Hospital·Phase 3·NCT05697471·120 enrolled

Show 2 more trials

Pain Associated With Endometriosis

Completed·LLumara Health, Inc.·Phase 2·NCT00758953·66 enrolled

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

Completed·VViramal Limited·Phase 2·NCT03352076·30 enrolled

Diabetic Macular Edema2 trials

Efficacy and Safety Study to Evaluate Two Doses of Oral DMI-5207 in Adult Subjects With Diabetic Macular Edema

Completed·UUnity Health Toronto·Phase 2·NCT02002403·34 enrolled

A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug) in the Treatment of Diabetic Macular Edema.

Completed·AAmpio Pharmaceuticals. Inc.·Phase 2·NCT01821677·354 enrolled

Myelofibrosis2 trials

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

Completed·—·Phase 3·NCT04173494·195 enrolled

Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

Completed·MMayo Clinic·Phase 2·NCT01732445·14 enrolled

Endometrial Cancer1 trial

Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00003946

12 more indications

Mastalgia1 trial

An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia

Completed·FFemmePharma Global Healthcare, Inc.·Phase 2·NCT01105793·20 enrolled

Endometrial1 trial

Effect of Danazol on Endometrial αvβ3 Integrin Expression in Patients With Unexplained Recurrent Implantation Failure

Completed·—·Phase 3·NCT03563664·38 enrolled

Dyskeratosis Congenita1 trial

Safety and Efficacy Trial of Danazol in Patients With Fanconi Anemia or Dyskeratosis Congenita

Terminated·—·Phase 1/2·NCT01001598·5 enrolled

Age1 trial

Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.

Completed·PParc de Salut Mar·Phase 1·NCT04757532·9 enrolled

Pulmonary Fibrosis1 trial

The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis

Terminated·TThe University of Queensland·Phase 2·NCT04638517·29 enrolled

Breast Disease1 trial

A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease

Completed·FFemmePharma Global Healthcare, Inc.·Phase 2·NCT00744276·60 enrolled

Efficacy and Safety1 trial

Evaluating Efficacy and Safety of Danazol in Severe Hematologic or Pulmonary Disease Related to Telomeropathy

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 1/2·NCT03710356·40 enrolled

Bone1 trial

Danazol for Genetic Bone Marrow and Lung Disorders

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT01441037·27 enrolled

Thrombotic Thrombocytopenic Purpura1 trial

Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT00953771·9 enrolled

Myelodysplastic Syndromes1 trial

Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes

Unknown status·PProf. Janet Dunn·Phase 2·NCT04997811·120 enrolled

Telomere Disease1 trial

Low Dose Danazol for the Treatment of Telomere Related Diseases

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT03312400·18 enrolled

Beta-Thalassemia1 trial

Safety and Efficacy of Combination Therapy (Danazol + Prednisolone + Thalidomide) in Thalidomide-Refractory Transfusion-Dependent β-Thalassemia Patients: A Prospective Randomized Controlled Clinical Trial

Recruiting·KKhyber Medical University Peshawar·Phase 3·NCT07884773·172 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

DANOCRINE

NDA NDA017557

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Danazol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Danocrine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Danazol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Danazol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017557). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Agonist; Progesterone Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

Danocrine

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Immune Thrombocytopenia9 trials

Endometriosis5 trials

Diabetic Macular Edema2 trials

Myelofibrosis2 trials

Endometrial Cancer1 trial

Mastalgia1 trial

Endometrial1 trial

Dyskeratosis Congenita1 trial

Age1 trial

Pulmonary Fibrosis1 trial

Breast Disease1 trial

Efficacy and Safety1 trial

Bone1 trial

Thrombotic Thrombocytopenic Purpura1 trial

Myelodysplastic Syndromes1 trial

Telomere Disease1 trial

Beta-Thalassemia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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