Vas Deferens RISUG

Reversible Inhibition of Sperm Under Guidance (RISUG)

User: Male
Hormonal: Non-Hormonal
Delivery type:
- Vas Deferens
Intended Duration:
- Long-Acting
Development Stage: Phase III
Developer(s)/researcher(s): Indian Council for Medical Research, Indian Institute of Technology, Kharagpur, University of Rajasthan

Details

API: SMA
Mechanism of Action:
- Vas Deferens Occlusion
Inactive Materials: DSMO
Regimen: Single Administration
MPT: Not Potential MPT
Promising Attributes: RISUG has the potential to offer both male and female patients a non-surgical option for sterilization.

Product Status

Active/Recent Clinical Development & Commercialization Activities

History

1979: RISUG, a single injection of styrene maleic anhydride dissolved in DMSO, is first tested as a non-surgical, reversible method of male sterilization. The product would be evaluated through animal studies - with varied results - from 1980-1993.
1993-Present: Researchers affiliated with IIT New Delhi publish the results of bench evaluation and Phase I and Phase II clinical trials, which find that while RISUG does generally produce infertility, further conclusions regarding safety and efficacy cannot be definitively made.
2019: Phase III trial results published that suggest that RISUG produces sustained (though not immediate) contraceptive efficacy. Additional Phase III research and regulatory application is planned.
2023: Additional Phase III trial results published, indicating high rates of azoospermia and no SAEs. Azoospermia was not universal, however, and method failure was 2.7%.
2025: Lead developer announces that a manufacturing facility for RISUG has been identified at SGT University.

Publications

Additional Information

2025 Media Coverage