What are the next opioid use disorder trial readouts?

Upcoming catalysts include Brenipatide (Primary completion Mar 2028 (RENEW-Op-1)) and Dexmedetomidine sublingual film (BXCL501) (Date TBD).

How many clinical trials are recruiting for opioid use disorder?

87 drug-interventional opioid use disorder trials are currently recruiting participants, out of 367 registered interventional trials.

Substance Use Disorders

Opioid use disorder drug pipeline

ICD-11 6C43
MeSH D009293

2 compounds from 2 companies are in active clinical development for opioid use disorder.

2Compounds

2Companies

0Phase 3+

2Upcoming readouts

92Trials recruiting

Phase 1/21

Dexmedetomidine sublingual film (BXCL501)BioXcel Therapeutics, Inc.alpha-2A adrenoceptor Agonist

Phase 21

BrenipatideEli Lilly and CompanyGlucagon-like peptide 1 receptor Agonist

Mechanisms: Peptide (1) · Small molecule (1)

Pipeline data compiled October 2026 · every fact sourced.

Upcoming readouts & recent results

Primary completion Mar 2028 (RENEW-Op-1)AnticipatedBrenipatideTopline dataNCT07420283
Date TBDAnticipatedDexmedetomidine sublingual film (BXCL501)Topline data
Larger confirmatory trial of BXCL501 in opioid withdrawal anticipated but not designed/scheduled as of Mar 2026. ↗
2026-03-05ReportedDexmedetomidine sublingual film (BXCL501)Topline datametNCT05712707
Investigator-sponsored Phase 1/2 (NCT05712707) topline: BXCL501 240 ug BID reduced opioid-withdrawal symptoms vs placebo (>30% SOWS-Gossop reduction) and numerically beat lofexidine with fewer adverse events. ↗

See the full catalyst calendar →

Compounds in development (2)

Compound	Company	Phase	Status	Mechanism
Brenipatide	Eli Lilly and Company	Phase 2	Active	Glucagon-like peptide 1 receptor Agonist
Dexmedetomidine sublingual film (BXCL501)	BioXcel Therapeutics, Inc.	Phase 1/2	Active	alpha-2A adrenoceptor Agonist

Trials recruiting now (87)

87 drug-interventional opioid use disorder trials recruiting now, of 367 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4A Bundled Intervention to End Opioid Overdoses
Buprenorphine (Experimental)
University of Alabama at Birminghamn=160United States · 1 siteStarted Sep 2026NCT07485335
Phase 4Examining Analgesic Synergy and Efficacy in Trauma Care
Buprenorphine, Oxycodone
Wake Forest University Health Sciencesn=282United States · 1 siteStarted Aug 2026NCT07435077
Phase 4NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Cabotegravir Injection, Cabotegravir Pill, Buprenorphine injection, Buprenorphine Pill
Duke Universityn=450United States · 1 siteStarted Jul 2026NCT06854029
Phase 4Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation
Injectable buprenorphine, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
University of California, San Franciscon=50United States · 1 siteStarted Jun 2026NCT07469501
Phase 4Methadone Rapid Restart
Methadone
Pouya Azarn=25Canada · 1 siteStarted May 2026NCT07546396
Phase 4Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg), Buprenorphine extended-release injection (300 mg/1.5 mL)
Pouya Azarn=12Canada · 2 sitesStarted Apr 2026NCT07439549
Phase 4Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Buprenorphine
Yale Universityn=60United States · 1 siteStarted Apr 2026NCT07176351
Phase 4Injectable Buprenorphine in Prison: A Preference Trial
Brixadi (Injectable Buprenorphine), Sublocade
Lifespann=60United States · 1 siteStarted Feb 2026NCT06880718
Phase 4Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
Ketamine, standard general anesthesia
Texas Tech University Health Sciences Centern=90United States · 2 sitesStarted Nov 2025NCT06903819
Phase 4Assessing Optimal XRB Initiation Points in Jail
Extended-Release Buprenorphine (XRB), Sublingual Buprenorphine (SLB)
NYU Langone Healthn=200United States · 4 sitesStarted Jun 2025NCT06051890
Phase 4Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery
Buprenorphine Transdermal System, Placebo Patch
Jenna-Leigh Wilsonn=100United States · 1 siteStarted Apr 2025NCT06949826
Phase 4Low-dose Buprenorphine Initiation for Opioid Use Disorder
buprenorphine-naloxone
Montefiore Medical Centern=70United States · 1 siteStarted Nov 2024NCT05450718

Showing the 12 most advanced of 87 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for opioid use disorder?: 2 compounds from 2 companies are in active clinical development for opioid use disorder.
What are the next opioid use disorder trial readouts?: Upcoming catalysts include Brenipatide (Primary completion Mar 2028 (RENEW-Op-1)) and Dexmedetomidine sublingual film (BXCL501) (Date TBD).
How many clinical trials are recruiting for opioid use disorder?: 87 drug-interventional opioid use disorder trials are currently recruiting participants, out of 367 registered interventional trials.