Gilgamesh secures $14M for ibogaine-like drug

New York-based Gilgamesh Pharmaceuticals has been awarded a $14 million grant by the National Institute on Drug Abuse (NIDA) to develop GM-3009, a substance intended as a safer alternative to ibogaine for treating substance use disorders, particularly opioid addiction.

GM-3009, its proprietary compound designed to help mitigate the cardiovascular risks associated with ibogaine, will undergo IND-enabling toxicology studies and Phase 1/1b clinical trials, thanks to the NIDA funding.

“Receiving this grant from NIDA is an important endorsement of Gilgamesh’s scientific rigor and commitment to addressing one of the most pressing public health crises of our time,” CEO Jonathan Sporn said in a statement.

“By funding these critical early-stage studies, NIDA is facilitating the translation of innovative scientific research into tangible treatments that can significantly impact public health.”

Ibogaine is a naturally occurring substance found in the root bark of the African shrub Tabernanthe iboga. It is known for its psychoactive properties, which means it can cause changes in perception, mood, and consciousness. Traditionally, it has been used in spiritual ceremonies in some African cultures.

But in recent years, ibogaine has gained attention in Western countries as a potential treatment for addiction, especially for opioids, because some people report that it reduces withdrawal symptoms and cravings. However, its use is controversial and not widely approved due to concerns about its safety, including the risk of heart problems and other serious side effects.

The trials will try to prove that GM-3009 is safe for human use and effective in reducing symptoms of opioid use disorder. Study success could pave the way for larger Phase 2 trials, moving the drug closer to potential approval and widespread use.

“GM-3009 represents a potential pivotal advance in the fight against the opioid epidemic, which claimed the lives of more than 100,000 Americans in 2023, as a rapid-acting, effective, durable, and safe treatment,” the company said in a statement.

Gilgamesh’s research portfolio including over 200 ibogaine analogs.

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