Professor Prajogo, the leading researcher on gendarussa, has studied it since 1985. He’s led the drug through the first two phases of clinical trials.In 2009, the phase-one study had 32 single men take the extract for 144 days. The 2010 phase-two study had 80 of 120 married men take the extract for 102 days. In 2012, the research team added an additional phase-two study which had 186 of 350 married men take the pill for 30 days. Only one pregnancy occurred during the trials.
Recent efforts have focused on having gendarussa registered as a new drug by the Indonesian FDA. Phase-3 research is now needed to confirm the effectiveness shown in the phase-2 studies and to evaluate safety in a larger number of men over a longer time period. The results of phase-3 research will also determine gendarussa’s duration of action and dosage.
Getting gendarussa approved in the US would likely be a significant hurdle. Much of the research would need to be repeated to comply with U.S. regulations.
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This approach to limit sperm motility has been studied since the mid 2000’s. The anti-Eppin drug has been found to work on human sperm and researchers have testable lead compounds ready to go. The next steps involve the toxicology testing which the FDA requires in order for the drug to move into Phase 1 clinical trials.Dr. Michael O’Rand is the lead developer of Eppin.
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The “clean sheets pill” was developed by Dr. Nnaemeka Amobi with Dr. Christopher Smith at King’s College of London. The research team is collaborating with Professor John Guillebaud, Emeritus Professor of Family Planning & Reproductive Health at University College London. Together, they’re seeking funding to begin the next phase of the study using rams. The drug is still being optimized to achieve 100% semen inhibition.
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Vasalgel is currently undergoing animal trials in the U.S. The project has produced a successful 12-month rabbit study which resulted in a rapid onset of infertility after injection with Vasalgel. The rabbits’ sperm then returned once the polymer was flushed out. Additional research on reversal methodology is ongoing while preparations for the first clinical trial are underway. Vasalgel is expected to be tested as a medical device with human clinical trials starting in late 2016. The rights to Vasalgel are owned by the Parsemus Foundation. The nonprofit aims to release Vasalgel to a broad market with affordable yet sustainable pricing as early as 2018 once regulatory requirements are met, assuming no setbacks.
Vasalgel is inspired from work on Reversible Inhibition of Sperm Under Guidance (RISUG), which also uses a polymer injected into the vas deferens. This approach was developed and patented in India by Dr. Sujoy Guha. The progress on RISUG is unclear at this time but has gone into Phase III human clinical trials.
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JQ1’s initial findings occured during a cancer study. The drug still needs to be isolated into a lead compound for specific use as a contraceptive. It would then need to undergo toxicology before beginning clinical trials.
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