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Danazol Treatment for Telomere Diseases
Open accessAbstract
BACKGROUND: Genetic defects in telomere maintenance and repair cause bone marrow failure, liver cirrhosis, and pulmonary fibrosis, and they increase susceptibility to cancer. Historically, androgens have been useful as treatment for marrow failure syndromes. In tissue culture and animal models, sex hormones regulate expression of the telomerase gene. METHODS: In a phase 1-2 prospective study involving patients with telomere diseases, we administered the synthetic sex hormone danazol orally at a dose of 800 mg per day for a total of 24 months. The goal of treatment was the attenuation of accelerated telomere attrition, and the primary efficacy end point was a 20% reduction in the annual rate of telomere attrition measured at 24 months. The occurrence of toxic effects of treatment was the primary safety end point. Hematologic response to treatment at various time points was the secondary efficacy end point. RESULTS: After 27 patients were enrolled, the study was halted early, because telomere attrition was reduced in all 12 patients who could be evaluated for the primary end point; in the intention-to-treat analysis, 12 of 27 patients (44%; 95% confidence interval [CI], 26 to 64) met the primary efficacy end point. Unexpectedly, almost all the patients (11 of 12, 92%) had a gain in telomere length at 24 months as compared with baseline (mean increase, 386 bp [95% CI, 178 to 593]); in exploratory analyses, similar increases were observed at 6 months (16 of 21 patients; mean increase, 175 bp [95% CI, 79 to 271]) and 12 months (16 of 18 patients; mean increase, 360 bp [95% CI, 209 to 512]). Hematologic responses occurred in 19 of 24 patients (79%) who could be evaluated at 3 months and in 10 of 12 patients (83%) who could be evaluated at 24 months. Known adverse effects of danazol--elevated liver-enzyme levels and muscle cramps--of grade 2 or less occurred in 41% and 33% of the patients, respectively. CONCLUSIONS: In our study, treatment with danazol led to telomere elongation in patients with telomere diseases. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01441037.).
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“The use of the androgen receptor agonist danazol in patients with aplastic anaemia with critically short telomeres improved their condition by increasing telomerase expression and lengthening telomeres. This provides support for a causative role of telomere length in this disease83.”
From Telomere dysfunction in ageing and age-related diseases (2022) · cites this paper as [83]
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“androgen therapy, based on the clinical use of danazol, a synthetic testosterone, has been part of clinical practice for many years in the treatment of aplastic anaemia with some efficacy83”
From Telomere dysfunction in ageing and age-related diseases (2022) · cites this paper as [83]
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Telomeres and Cellular Senescence in Metabolic and Endocrine Diseases
Matsumoto, R., & Takahashi, Y. (2016) · InTech eBooks · doi:10.5772/64759 · Cited by 3
Aoki, Y., Aoki, M., & Yamada, K. (2017) · Gerontology and Geriatric Medicine · doi:10.1177/2333721417696672 · Cited by 3
Čeponis, J., Wang, C., Swerdloff, R. S., & Liu, P. Y. (2017) · Endocrinology · doi:10.1007/978-3-319-29456-8_11-1 · Cited by 3
Guérin, C., Crestani, B., Dupin, C., Kawano-Dourado, L. B., Ba, I., Kannengiesser, C., & Borie, R. (2022) · Revue des Maladies Respiratoires · doi:10.1016/j.rmr.2022.03.011 · Cited by 4
Telomere Biology Disorder: A Focus on Gastrointestinal and Hepatic Manifestations
Warsame, F., & Simonetto, D. A. (2024) · Current Hematologic Malignancy Reports · doi:10.1007/s11899-023-00723-6 · Cited by 3
Gupta, M., Shanmukhaiah, C., Vundinti, B. R., Jose, A., Tiwari, S. S., Bhowmick, A. R., & Madkaikar, M. R. (2024) · Clinical & Experimental Immunology · doi:10.1093/cei/uxae076 · Cited by 3
Portillo, A. M., García-Velasco, J. A., & Varela, E. (2024) · Mathematical Biosciences · doi:10.1016/j.mbs.2024.109305 · Cited by 3
Telomere Disorders and the Liver
Calleri, A., & Simonetto, D. A. (2025) · Clinics in Liver Disease · doi:10.1016/j.cld.2025.03.001 · Cited by 3
Danazol treatment for telomere biology disorders: long-term results of a phase 1/2 study
Lee, N. C. J., Gutierrez‐Rodrigues, F., Shalhoub, R. N., Machado, T. R., Lotter, J., Alemu, L., Raffo, D. Q., Paul, S., Kajigaya, S., Aubert, G., et al. (2025) · Blood Advances · doi:10.1182/bloodadvances.2025017860 · Cited by 3
Self-citationPeripheral blood telomere alterations in ground glass opacity (GGO) lesions may suggest malignancy
Koslow, M., Shitrit, D., Israeli‐Shani, L., Uziel, O., Beery, E., Osadchy, A., Refaely, Y., Shochet, G. E., & Amiel, A. (2019) · Thoracic Cancer · doi:10.1111/1759-7714.13026 · Cited by 3
Derenzini, E., Risso, A., Ruella, M., Spatola, T., Milone, G., Pioltelli, P. E., Iori, A. P., Santarone, S., Bosi, A., Rambaldi, A., et al. (2019) · Transplantation and Cellular Therapy · doi:10.1016/j.bbmt.2019.03.026 · Cited by 3
Wulaningsih, W., Astuti, Y., Matsuguchi, T., Anggrandariyanny, P., & Watkins, J. A. (2016) · The Prostate · doi:10.1002/pros.23245 · Cited by 3
Diagnosis and management of childhood aplastic anaemia
Clesham, K., Bhatnagar, N., & Samarasinghe, S. (2019) · Paediatrics and Child Health · doi:10.1016/j.paed.2019.05.001 · Cited by 3
Young, N. S., & Maciejewski, J. P. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-35762-3.00030-5 · Cited by 3
Self-citationČeponis, J., Wang, C., Swerdloff, R. S., & Liu, P. Y. (2017) · Endocrinology · doi:10.1007/978-3-319-44441-3_11 · Cited by 3
Syndrome des télomères courts chez l’adulte : une entité rare qu’il faut savoir évoquer
Coukos, A., Daccord, C., Lazor, R., Blum, S., Naveiras, O., Unger, S., Vionnet, J., Gaide, O., Koutsokera, A., Moschouri, E., et al. (2022) · JMIG · doi:10.53738/revmed.2022.18.793.1606 · Cited by 3
Telomeropathy: pretransplant and posttransplant considerations for clinicians
Mackintosh, J. A. (2025) · Current Opinion in Pulmonary Medicine · doi:10.1097/mcp.0000000000001169 · Cited by 2
“There has been much interest in the potential efficacy of danazol in patients with short telomeres. individuals primarily with haematological manifestations of TBD [20].”
Telomere Dynamics in Cardiovascular Aging: From Molecular Mechanisms to Precision Medicine
Mohammadi, A., Jones, D. T., Mohammadi, S., Heidari‐Bateni, G., Frishman, W. H., & Aronow, W. S. (2025) · Cardiology in Review · doi:10.1097/crd.0000000000001018 · Cited by 2
Zhavoronkov, A. A., Wilczok, D., Ren, F., & Galkin, F. (2025) · Aging · doi:10.18632/aging.206301 · Cited by 2
Carlier, F. M., Planté-Bordeneuve, T., Froidure, A., Graux, C., van Dievoet, M., van Moorsel, C. H. M., & Hoffman, T. W. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1718107 · Cited by 2
“There is not enough evidence to recommend the use of danazol for bone marrow disease after solid organ transplantation in patients with TBD (260).”
Established and emerging non-cellular therapies in inherited bone marrow failure syndromes
Janczar, S., Urbański, B., Ussowicz, M., & Mlynarski, W. M. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1773574 · Cited by 2
Planté-Bordeneuve, T., Haouas, H., Vanderheyde, K., & Froidure, A. (2018) · Acta Clinica Belgica · doi:10.1080/17843286.2018.1545375 · Cited by 2
“a synthetic androgen, was halted early because the primary end point, reduction in telomere attrition, was reached in all evaluable patients [26].”
BackgroundNew Trends in Nontransplant Therapy for Acquired Aplastic Anemia
Ding, S., & Fu, R. (2022) · Current Pharmaceutical Design · doi:10.2174/1381612828666220418132432 · Cited by 2
Choudhary, D., Lekshmon, K. S., Singh, C., Subramani, V. N., Singh, Y., Mitra, S., Sekar, A., Malik, M., Bhagat, N., Kumar, Y., et al. (2024) · Journal of Clinical and Experimental Hepatology · doi:10.1016/j.jceh.2024.101355 · Cited by 2
Casual effects of telomere length on sarcoidosis: a bidirectional Mendelian randomization analysis
Zhu, S., Hao, Z., Chen, Q., Liu, X., Wu, W., Luo, Y., & Zhang, F. (2024) · Frontiers in Medicine · doi:10.3389/fmed.2024.1408980 · Cited by 3
Pancreatitis as a Potential Consequence of Danazol Therapy for Telomere Biology Disorders
McCullough, K. B., Vege, S. S., Mangaonkar, A. A., Ferrer, A., & Patnaik, M. M. (2024) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2024.03.019 · Cited by 2
Modi, P. D., Pennington, K. M., Shah, S., Mangaonkar, A. A., & Goswami, U. (2024) · Transplantation Proceedings · doi:10.1016/j.transproceed.2024.10.038 · Cited by 2
Telomerase-Mediated Anti-Ageing Interventions
Dunn, P. L., Logeswaran, D., & Chen, J. J. ‐. (2024) · Sub-cellular biochemistry/Subcellular biochemistry · doi:10.1007/978-3-031-66768-8_1 · Cited by 2
Metadata
- Authors
- Townsley, D. M., Dumitriu, B., Liu, D., Biancotto, A., Weinstein, B., Chen, C., Hardy, N., Mihalek, A. D., Lingala, S., Kim, Y. J., Yao, J., Jones, E., Gochuico, B. R., Heller, T., Wu, C. O., Calado, R. T., Scheinberg, P., & Young, N. S.
- Affiliations
- National Institutes of Health (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-05-19
- Volume
- 374
- Issue
- 20
- Pages
- 1922-1931
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4968696
- OpenAlex
- W2394724717
- Cited by
- 415
- References
- 40
- Citations by year
- 2026: 23 · 2025: 32 · 2024: 36 · 2023: 46 · 2022: 32 · 2021: 45 · 2020: 46 · 2019: 41 · 2018: 49 · 2017: 46 · 2016: 19
- FWCI
- 41.60
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- HAL (submittedVersion)
- Funders
- National Institutes of Health (Z99 HL999999)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Telomeres, Telomerase, and Senescence
- Health Sciences › Medicine › Hematology › Blood disorders and treatments
- Life Sciences › Immunology and Microbiology › Immunology › Immunodeficiency and Autoimmune Disorders
- Keywords
- danazol, telomere shortening, telomere length, telomerase, sex hormones, androgens, bone marrow failure syndromes, telomere maintenance, telomere elongation, hematologic response, liver cirrhosis, pulmonary fibrosis, drug safety, elevated liver enzymes, muscle cramps, treatment discontinuation
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Bone Marrow Diseases, Danazol, Estrogen Antagonists, Female, Hair Color, Humans, Liver Cirrhosis, Male, Middle Aged, Mutation, Prospective Studies, Pulmonary Fibrosis, Up-Regulation, Telomere, Telomerase, Young Adult
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