Mitragynine IND Approved, Paving Way for Opioid Therapy

FDA has granted an IND for mitragynine, the main psychoactive compound in kratom, allowing the first human safety trial for opioid use disorder.

From Lab to IND

NIH scientists at the National Center for Advancing Translational Sciences (NCATS) and the National Institute on Drug Abuse (NIDA), in partnership with the University of Florida, purified mitragynine and completed the preclinical work that led to the IND submission. The formulation will be the exact compound used in the upcoming trial, ensuring consistency between animal studies and human dosing.

Preclinical Safety Profile

Preclinical studies, led by researchers at the University of Florida and NIH’s NCATS and NIDA, administered mitragynine across several doses to animal models. Results showed no significant safety concerns, a critical milestone that enabled the IND approval. Researchers highlighted that the therapeutic effects of kratom likely stem from the slow conversion of mitragynine in the body, a mechanism that remains to be explored in humans.

Next Steps: Phase I Trial

With the IND in effect, investigators will launch a randomized, double‑blind, placebo‑controlled phase‑I study to assess safety and tolerability in humans. The trial, part of the NIH Helping to End Addiction Long‑term® (HEAL) Initiative, will enroll participants with opioid use disorder and monitor adverse events, pharmacokinetics, and preliminary efficacy signals. Director Joni Rutter, Ph.D., of NCATS, emphasized that this work could pave the way for a new treatment option and support recovery pathways.

Why It Matters

Opioid use disorder continues to drive high overdose mortality rates across the United States. Expanding treatment options beyond existing medications could reduce relapse and improve outcomes for millions of patients. The mitragynine IND represents a concrete step toward diversifying the therapeutic arsenal and underscores NIH’s commitment to translating laboratory findings into clinical solutions.

The forthcoming trial will determine whether mitragynine’s promising preclinical profile translates into a safe, tolerable, and potentially effective therapy for opioid use disorder, setting the stage for larger efficacy studies.

Source: NIH research clears way for study of experimental treatment for opioid use disorder
Domain: nih.gov