Optina (danazol ultra low dose) / Ampio - LARVOL DELTA

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting ➔ Completed | Trial completion date: Oct 2027 ➔ Oct 2025 | Trial primary completion date: Apr 2027 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Neutropenia • DKC1 • RTEL1 • TERT

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Recruiting ➔ Active, not recruiting | N=40 ➔ 18

Enrollment change • Enrollment closed • Neutropenia • DKC1 • RTEL1 • TERT

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial primary completion date • Neutropenia • DKC1 • RTEL1 • TERT

Hereditary angioedema prevalence and satisfaction with prophylaxis in South Australia. (PubMed, World Allergy Organ J) - "Many patients (mostly male) with milder disease had responded well to low-dose danazol with good tolerance and have continued to use it, whereas patients with higher disease burden are now using newer therapies, and overall satisfaction with current prophylaxis is high. Prevalence of HAE in South Australia aligns with international reports. Our population survey indicates that current long-term prophylaxis therapies including danazol, lanadelumab and C1-inhibitor, applied to appropriate patients taking into account disease activity and drug risks and tolerance, are effective for HAE attack prevention and produce high levels of satisfaction."

Journal • Cardiovascular • Complement-mediated Rare Disorders • Genetic Disorders • Hereditary Angioedema • Primary Immunodeficiency

A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug) in the Treatment of Diabetic Macular Edema. (clinicaltrials.gov) - P2 | N=354 | Completed | Sponsor: Ampio Pharmaceuticals. Inc. | Phase classification: P3 ➔ P2

Phase classification • Diabetic Macular Edema • Ophthalmology

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Apr 2026 ➔ Oct 2027

Trial completion date • TERT

Acquired Angioedema in B Cell Lymphoproliferative Disease: A Retrospective Case Series. (PubMed, Clin Exp Immunol) - "In acute attacks, patients may be resistant to C1-INH therapy due to the presence of anti-C1-INH autoantibodies or rapid complement consumption, and may respond better to icatibant or ecallantide, which directly affect bradykinin...With close monitoring, low-dose danazol can be effective for long-term prophylaxis. Annual evaluation in AAE-C1-INH is recommended if an underlying malignancy is not found, as angioedema may precede the development of malignancy by several years. Our single center study has aided in standardization of comprehensive AAE-C1-INH diagnosis, treatment, and monitoring strategies towards future therapeutic clinical trials."

Journal • Retrospective data • Cardiovascular • Oncology

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: National Heart, Lung, and Blood Institute (NHLBI); Trial completion date: Sep 2021 ➔ Apr 2026; Trial primary completion date: Sep 2021 ➔ Apr 2026

Trial completion date • Trial primary completion date • TERT

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

New P2 trial • Neutropenia • TERT

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: National Heart, Lung, and Blood Institute (NHLBI); Initiation date: Mar 2018 ➔ Mar 2018

Trial initiation date • Neutropenia • TERT

Low-Dose Danazol for the Treatment of Telomere Related Diseases (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: National Heart, Lung, and Blood Institute (NHLBI); Not yet recruiting ➔ Recruiting

Enrollment open • Neutropenia • TERT