Drugs / Oliceridine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) OLINVYK 2020-08-07 fda.gov

Trials 33 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT02344303 Dec 2014 → May 2015 Trevena Inc. Completed No outcome recorded
Phase 1 NCT02169934 Jun 2014 → Jan 2015 Trevena Inc. Completed No outcome recorded
Phase 1 NCT02083315 Jul → Aug 2013 Trevena Inc. Completed No outcome recorded
Phase 23 trials
Phase 2 NCT02520297 Oct 2015 Trevena Inc. Terminated No outcome recorded
Phase 2 NCT02335294 Dec 2014 → Jul 2015 Trevena Inc. Completed No outcome recorded
Phase 2 NCT02100748 Apr → Oct 2014 Trevena Inc. Completed No outcome recorded
Phase 33 trials
Phase 3 NCT02815709 May → Dec 2016 Trevena Inc. Completed No outcome recorded
Phase 3 NCT02820324 May → Dec 2016 Trevena Inc. Completed No outcome recorded
Phase 3 NCT02656875 Dec 2015 → May 2017 Trevena Inc. Completed No outcome recorded
Phase 411 trials
Phase 4 NCT07660380 Jun → Jul 2026 overdue Shiyou Wei Not yet recruiting No outcome recorded
Phase 4 NCT07018375 Jan 2026 → Mar 2027 expected chronic pain syndrome Tianjin Medical University General Hospital Enrolling by invitation No outcome recorded
Phase 4 NCT06530563 Aug 2025 → Apr 2026 overdue Xiangya Hospital of Central South University Not yet recruiting No outcome recorded
Phase 4 NCT07026162 Jul 2025 → Feb 2026 YanYing Xiao Completed No outcome recorded
Phase 4 NCT06619145 Nov 2024 → Oct 2026 expected Nanjing First Hospital, Nanjing Medical University Not yet recruiting No outcome recorded
Phase 4 NCT06320041 Aug 2024 → Dec 2026 expected The Fourth Affiliated Hospital of Zhejiang University School of Medicine Recruiting No outcome recorded
Phase 4 NCT06458400 Jul → Sep 2024 Yuwei Qiu Completed No outcome recorded
Phase 4 NCT06411665 Jul 2024 → Mar 2025 Peking University First Hospital Completed No outcome recorded
Phase 4 NCT06454292 Jun 2024 → Dec 2025 Chun Pan Unknown No outcome recorded
Phase 4 NCT05465226 Apr → Sep 2023 respiratory underresponsiveness to hypoxia and hypercapnia University of Tennessee Completed No outcome recorded
Phase not applicable13 trials
NCT07707258 Jul → Sep 2026 expected Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
NCT07650812 Jul 2026 → Dec 2027 expected bowel dysfunction Beijing Tiantan Hospital Not yet recruiting No outcome recorded
NCT07479446 Mar 2026 → Aug 2027 expected cerebellopontine angle tumor Xuanwu Hospital, Beijing Recruiting No outcome recorded
NCT07307495 Jan 2026 → Jul 2027 expected Xijing Hospital Not yet recruiting No outcome recorded
NCT07372209 Oct → Dec 2025 Tangshan Maternal and Child Health Hospital Completed No outcome recorded
NCT07187765 Sep → Nov 2025 Shiyou Wei Completed No outcome recorded
NCT07154979 Sep 2025 Shiyou Wei Completed No outcome recorded
NCT07713134 Aug 2025 → May 2026 Tangshan Maternal and Child Health Hospital Completed No outcome recorded
NCT07112157 Aug 2025 → Aug 2026 overdue strabismus Henan Provincial People's Hospital Not yet recruiting No outcome recorded
NCT07097038 Jul → Dec 2025 overdue Henan Provincial People's Hospital Not yet recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT07306702 Background Jun 2026 → May 2027 Shenyang Sixth People's Hospital Withdrawn No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 37 sources stand behind the page.

FieldValueCited text
Known as Oliceridine “Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery” NCT07307495
26

“Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery” NCT06320041

NCT02820324

NCT06619145

NCT07660380

NCT07097038

NCT07707258

NCT07306702

NCT06411665

NCT05465226

NCT07479446

NCT06458400

NCT07187765

NCT06990893

NCT06454292

NCT07112157

NCT07026162

NCT06409689

NCT07713134

NCT07650812

NCT06530563

NCT02815709

NCT07154979

NCT07372209

NCT07018375

NCT06668298

NCT04979247

Known as Oliceridina ChEMBL registry synonym — accepted as the source's own label CHEMBL2443262
Known as Oliceridine Fumarate “Drug: Oliceridine FumarateNCT06454292
Known as Oliceridine fumarate injection Oliceridine fumarate injectionNCT06530563
Known as Olinvyk “Drug: Oliceridine Injection [Olinvyk]” NCT06530563
Known as Olynvik ChEMBL registry synonym — accepted as the source's own label CHEMBL2443262
Known as TRV130 “A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy” NCT02815709
8

“Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the μ-Opioid” PMID 31162798 Jun 2019

NCT02169934

NCT02083315

NCT02520297

NCT02335294

NCT02100748

NCT02656875

NCT02344303

Action Activate “Biased agonism of the μ-opioid receptor by TRV130 increases analgesia” PMID 24954166 Jun 2014
1

“Mu opioid receptor agonist” CHEMBL2443262

Modality Other / unclassified “Oliceridine is a G-protein biased μ-opioid receptor agonist” NCT06619145
Route Intravenous “Thirty healthy men received single intravenous injections of the biased ligand TRV130” PMID 24954166 Jun 2014
Target OPRM1 “Mu opioid receptor agonist” CHEMBL2443262