noribogaine (DMX-NB1) / DemeRx - LARVOL DELTA

DMX-NB-001: Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: DemeRx NB | Recruiting ➔ Completed

Trial completion

DMX-NB-001: Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: DemeRx NB | Not yet recruiting ➔ Recruiting

Enrollment open

Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: DemeRx NB

New P1 trial

Evaluating the toxicity and therapeutic potential of ibogaine in the treatment of chronic opioid abuse. (PubMed, Expert Opin Drug Metab Toxicol) - No abstract available

Journal • Substance Abuse

[VIRTUAL] Catalyst for Change: Novel Treatments in Substance Use Disorder (CPDD 2020) - "The first presentation will focus on preclinical and clinical data which support development of noribogaine as a non-opioid alternative for the management of withdrawal symptoms following abrupt discontinuation. The approach is based on a highly selective immunotherapy that reduces the rate and extent of methamphetamine penetration into the CNS. This therapeutic approach will keep the patient from experiencing the effect of methamphetamine and may improve their ability to adhere to therapy while abstaining from methamphetamine."

Addiction (Opioid and Alcohol) • CNS Disorders

[VIRTUAL] Catalyst for Change: Novel Treatments in Substance Use Disorder - Managing Opioid Dependence With Low-Dose Noribogaine (CPDD 2020) - No abstract available

Addiction (Opioid and Alcohol) • Pain

Ibogaine Acute Administration in Rats Promotes Wakefulness, Long-Lasting REM Sleep Suppression, and a Distinctive Motor Profile. (PubMed, Front Pharmacol) - "In addition, it produces a dose-dependent unusual motor profile along with other serotonin-related behaviors. Since ibogaine is metabolized to produce noribogaine, further experiments are needed to elucidate if the metabolite and/or the parent drug produced these effects."

Journal • Preclinical • Biosimilar

A Single Administration of the Atypical Psychedelic Ibogaine or its Metabolite Noribogaine Induces an Antidepressant-like Effect in Rats. (PubMed, ACS Chem Neurosci) - "At this time point, both ibogaine and noribogaine were present in rat brain at concentrations that cannot produce the same behavioral outcome on their own (ibogaine ~ 0.5 M, noribogaine ~ 2.4 M). Our data suggests a polypharmacological mechanism underpinning the antidepressant-like effects of ibogaine and noribogaine."

Journal • Preclinical • CNS Disorders • Depression • Mood Disorders • Psychiatry • BDNF

ATAI Life Sciences announces joint venture with DemeRx to develop ibogaine for opioid use disorder (PRNewswire) - "ATAI Life Sciences...today announced an investment in two separate joint ventures (JV) with DemeRx, a clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of opioid use disorder (OUD)....Due to the extensive database for ibogaine, including a substantial amount of human data, ATAI and DemeRx plan to submit Clinical Trial Applications for a Phase II study in opioid-dependent patients."

Licensing / partnership • Regulatory

Psychedelics Promote Structural and Functional Neural Plasticity. (PubMed, Cell Rep) - "Here, we report that, like ketamine, serotonergic psychedelics are capable of robustly increasing neuritogenesis and/or spinogenesis both in vitro and in vivo...The structural changes induced by psychedelics appear to result from stimulation of the TrkB, mTOR, and 5-HT2A signaling pathways and could possibly explain the clinical effectiveness of these compounds. Our results underscore the therapeutic potential of psychedelics and, importantly, identify several lead scaffolds for medicinal chemistry efforts focused on developing plasticity-promoting compounds as safe, effective, and fast-acting treatments for depression and related disorders."

Journal