Industry Update: Mitragynine Receives Investigational New Drug (IND) Status from NIH

On June 1, the National Institutes of Health (NIH) announced that mitragynine, the most abundant alkaloid in kratom, has been cleared as an Investigational New Drug (IND). With IND status, scientists at University of Florida are now authorized to study the effects of pure mitragynine in human subjects. National Institute on Drug Abuse (NIDA) Director Nora Volkow said in a news release, “This IND is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates.”

Multiple guests on the Kratom Science Podcast have shared personal stories about consuming kratom to aid them in their recovery from problematic opioid use. They have also consumed kratom for other issues, including pain management. However, if and when mitragynine achieves approval as a new drug during this specific process, it will only be approved for OUD, and not as a pain reliever (unless a separate IND application is submitted for that purpose). According to the news release, the trial is part of the Helping to End Addiction Long-term® Initiative (NIH HEAL Initiative ®), established in 2018 as a response to the opioid crisis.

Approval for a new drug is a long and expensive process, typically lasting 8-15 years and costing hundreds of millions of billions of dollars. University of Florida researchers, many of whom have appeared on the Kratom Science Podcast, have spent years studying kratom leading up to the IND authorization for mitragynine. Their work includes preclinical animal studies, in vitro research, and pharmacokinetic analyses required for the IND application process. The first stage of human testing is known as Phase 1 clinical trials (You can keep track of the MG001 Phase 1 clinical trial on ClinicalTrials.gov). These studies are usually small, often involving between 20 and 100 participants. Their primary purpose is to evaluate the drug’s safety, determine appropriate dosage ranges, understand how the drug is absorbed and eliminated by the body, and identify common side effects. Phase 1 studies are not intended to prove that the drug effectively treats a disease. The Phase 1 trial for mitragynine (called MG001 in the study) is estimated to begin in September 2026 and be completed by April 2027 and will include 32 healthy adult volunteers who will receive either a placebo or a 25, 50, 75, or 100mg dose of mitragynine. Participants’ health will be monitored and blood will be drawn to study mitragynine’s pharmacokinetics. If Phase 1 is successful, the drug moves into Phase 2 clinical trials, which typically involve several dozen to several hundred participants who have the condition the drug is intended to treat. Researchers begin evaluating whether the drug actually works while continuing to monitor its safety. They also compare different doses to identify the one that provides the greatest benefit with the fewest side effects.

Source: Kratom Science via Sentinel Newsroom