naltrexone SR implant (BICX104) / BioCorRx - LARVOL DELTA

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: BioCorRx Pharmaceuticals Inc

New P1 trial

BioCorRx Provides Business Update for the First Quarter of 2023 (GlobeNewswire) - P1 | N=24 | NCT04828694 | Sponsor: BioCorRx Inc | "we reported interim positive safety and pharmacokinetic (PK) results for the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD)...This confirms our expectations that BICX104 naltrexone pellets can be safely administered without significant risk. Based on these results, we are preparing submissions for fast-track designation and expanded access. We hope to get both submitted in the second quarter of 2023 pending final preparation by our regulatory team."

Fast track designation • P1 data • Addiction (Opioid and Alcohol) • CNS Disorders

Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: BioCorRx Inc | Active, not recruiting ➔ Completed

Trial completion • Substance Abuse

Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: BioCorRx Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse

Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: BioCorRx Inc | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2022 ➔ Mar 2023 | Trial primary completion date: Feb 2022 ➔ Dec 2022

Enrollment open • Trial completion date • Trial primary completion date • Substance Abuse

"$BICX BioCorRx Announces Submission of IND Application to the FDA for BICX104, Implantable Naltrexone https://t.co/mxHWKCM0iU" (@stock_titan)

Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: BioCorRx Pharmaceuticals, Inc.

New P1 trial

Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX (clinicaltrials.gov) - P2; N=200; Completed; Sponsor: University of Pennsylvania; Recruiting ➔ Completed; Phase classification: P3 ➔ P2

Phase classification • Trial completion • Biosimilar • Gene Therapies • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease

Naltrexone implants for opioid use disorder: Relapse prevention, craving, anhedonia, and HIV prevention (CPDD 2018) - No abstract available.

Addiction (Opioid and Alcohol) • Biosimilar • CNS Disorders • Gene Therapies • Genetic Disorders • Psychiatry

Naltrexone maintenance fails to alter amphetamine effects on intracranial self-stimulation in rats. (PubMed, Exp Clin Psychopharmacol) - "Our results do not support naltrexone as a pharmacotherapy for amphetamine and cocaine abuse and also suggest that termination from chronic naltrexone does not increase sensitivity to abuse-related morphine or amphetamine effects in ICSS. (PsycINFO Database Record"

Journal • Biosimilar

BioCorRx announces award of $2.8 million, the second tranche of a NIDA grant for the development of BICX102, a sustained release naltrexone implant for the treatment of opioid use disorder (Streetinsider.com) - "BioCorRx...has been awarded an additional $2.8 million. This is the second tranche from the total grant of approximately $5.7 million announced last year. The grant was awarded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number UG3DA047925. The grant is for the development of BICX102, the Company’s 3-month, sustained release naltrexone implant for the treatment of opioid use disorder."

Grant

OLANI PK/Safety Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Go Medical Industries Pty Ltd

Clinical • New P1 trial