TRV734
/ Trevena
- LARVOL DELTA
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April 04, 2025
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
(clinicaltrials.gov)
- P2 | N=4 | Completed | Sponsor: National Institute on Drug Abuse (NIDA) | Recruiting ➔ Completed | N=64 ➔ 4 | Trial completion date: Sep 2026 ➔ Feb 2025 | Trial primary completion date: Sep 2026 ➔ Feb 2025
Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Substance Abuse
August 23, 2023
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
(clinicaltrials.gov)
- P2 | N=64 | Recruiting | Sponsor: National Institute on Drug Abuse (NIDA) | Trial completion date: Sep 2023 ➔ Sep 2026 | Trial primary completion date: Sep 2023 ➔ Sep 2026
Trial completion date • Trial primary completion date • Substance Abuse
October 13, 2022
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
(clinicaltrials.gov)
- P2 | N=64 | Recruiting | Sponsor: National Institute on Drug Abuse (NIDA) | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023
Trial completion date • Trial primary completion date • Substance Abuse
June 01, 2022
TRV734 as a Potential Medication for Opioid-Use Disorder: Protocol for a Dose-Finding Pilot and a Proof-Of-Concept Human Laboratory Study
(CPDD 2022)
- "In humans, intravenous administration of the mu-opioid receptor (MOR) agonist TRV130 decreases moderate-to-severe acute pain and trends towards having fewer side-effects than morphine. We predict that TRV734 will suppress opioid withdrawal symptoms with fewer side-effects than oxycodone. If proven, this will support advancing long-acting formulations of TRV734 for OUD treatment. Even modest increases in the proportion of patients who are unresponsive to buprenorphine or methadone, but who respond to TRV734, would be a significant public health benefit."
Clinical • Addiction (Opioid and Alcohol) • Pain • Substance Abuse
September 05, 2021
Two-Part Phase 1 Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of TRV734 in Healthy Adults.
(PubMed, Clin Pharmacol Drug Dev)
- "There was a dose-related decrease in pupil diameter following administration of TRV734 up to TRV734 125 mg every 6 hours. A favorable trend in bowel function index for TRV734 warrants continued study."
Clinical • Journal • P1 data • PK/PD data • Pain
May 26, 2021
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
(clinicaltrials.gov)
- P2; N=53; Recruiting; Sponsor: National Institute on Drug Abuse (NIDA); Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • Substance Abuse
February 05, 2014
Trevena initiates clinical development of TRV734, a novel biased ligand for moderate to severe pain
(Trevena Press Release)
- "Trevena...today announced the initiation of its first Phase 1 trial for TRV734, a novel drug candidate in development as an orally administered treatment for moderate to severe acute and chronic pain....The main objective of this first-in-human trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of TRV734 in healthy subjects."
New P1 trial • Pain
June 03, 2018
Biased ligands as a path to safer analgesics (oliceridine, TRV734 and TRV250)
(CPDD 2018)
- No abstract available.
Biosimilar • CNS Disorders • Pain
March 26, 2020
Trevena pauses enrollment in proof-of-concept clinical trials for TRV250 And TRV734
(Reuters)
- “Trevena…announced that enrollment has been paused in proof-of-concept clinical trials for trv250 and trv734….Trevena - withdrawing previous guidance with respect to timing of top line data for TRV250 and TRV734....Announced the U.S. FDA review of the resubmission of NDA for oliceridine is ongoing; Expects the FDA’S PDUFA goal date for completion of the FDA’s review of the NDA for oliceridine to remain August 7, 2020."
Enrollment status • NDA • PDUFA date
March 20, 2020
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
(clinicaltrials.gov)
- P2; N=53; Not yet recruiting; Sponsor: National Institute on Drug Abuse (NIDA)
Clinical • New P2 trial
July 10, 2019
A First-in-Human Clinical Study With TRV734, an Orally Bioavailable G-Protein-Biased Ligand at the μ-Opioid Receptor.
(PubMed, Clin Pharmacol Drug Dev)
- "Following administration of TRV734 125 mg under fasted or fed conditions, there was no significant difference in bioavailability when given as a solution or drug in capsule to fasted subjects. When drug in capsule was given to subjects following a high-fat meal, absorption was slowed, resulting in decreased peak concentrations, but area under the plasma concentration-time curve was not affected."
Clinical • Journal • P1 data
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