Dimethandrolone Undecanoate (DMAU)
- User: Male
- Hormonal: Hormonal
-
Delivery type:
- Multiple
- Oral
- Injectable
-
Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): BIOQUAL, Inc, NICHD, Washington State University, Lundquist Institute at Harbor UCLA Medical Center, University of Washington
Details
- API: Dimethandrolone Undecanoate
- Target: Androgen Receptor
-
Mechanism of Action:
- Not Yet Determined
- Inactive Materials: Not Yet Determined
- Regimen: 1 Pill/Day (Oral), 1 Injection/3 Months (Injection)
- MPT: Not Potential MPT
- Promising Attributes: DMAU has potential to be administered as a pill or to be a long-acting injectable, both delivery systems that align with user needs and/or preferences.
Product Status
Active/Recent Pre-Clinical and Clinical Development
History
Synthesized and first evaluated by BIOQUAL in 2006. Additional development (bench science, pre-clinical and clinical) has been largely driven by the NIH Contraceptive Development Program, with participation from academic centers.
2012: Ph I study assessing safety and tolerability of DMAU initiated at the Los Angeles Biomedical Research Institute and the University of Washington. Study included 28-day repeat-dose dose-escalation.
2017: Ph I multi-center, double-blind dose range finding study to evaluate the safety, tolerability, PK, and PD of intramuscular or subcutaneous injection of DMAU initiated at LA Biomedical Research Institute and University of Washington. The study reached its primary endpoint in November 2024 and its full completion in April 2025.
2018: Ph II study assessing suppression of spermatogenesis after oral administration of DMAU initiated at LA Biomedical Research Institute and the University of Washington with 100 participants over 12 weeks of treatment.
2024: An animal study in cynomolgus macaques and rhesus macaques evaluating repeat dose oral and IM administration of DMAU has no significant toxicological findings. Dose dependence was not observed for serum DMA concentrations, suggesting a depot effect. Fertility indicators suggest potential contraceptive efficacy. Testosterone levels and sperm production returned following method discontinuation. These results are supportive of later-stage clinical evaluation.
Publications
doi: 10.1210/en.2005-1524
doi: 10.1124/dmd.122.001041
doi: 10.1111/andr.13025
doi: 10.1210/clinem/dgaa761
doi: 10.1016/j.contraception.2020.04.006
doi: 10.1210/jc.2018-01452
doi: 10.1111/andr.12303
doi: 10.1111/j.2047-2927.2014.00216.x
doi: 10.2164/jandrol.110.011817
doi: 10.2164/jandrol.110.010371
doi: 10.1210/en.2005-1524