Drugs / Oliceridine

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed China (NMPA) OLINVYK acute pain 2022-01-27

“today announced that China’s National Medical Products Administration (NMPA) has accepted submission of a New Drug Application (NDA) for oliceridine injection.” trevena.com ↗

“Jiangsu Nhwa submitted a New Drug Application for OLINVYK to China’s National Medical Products Administration (NMPA) in January 2022.” trevena.com ↗

Approved US (FDA) OLINVYK — 2020-08-07 fda.gov ↗
Filed US (FDA) — acute pain 2020-02-10

“we reached a significant milestone for the oliceridine program, with our resubmission and FDA’s acceptance of the NDA.” trevena.com ↗

“today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” trevena.com ↗

“FDA has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine” trevena.com ↗

Rejected (CRL) US (FDA) — acute pain 2018-11-02

“today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine.” trevena.com ↗

“FDA related to the oliceridine complete response letter (CRL).” trevena.com ↗

Filed US (FDA) — acute pain 2018-01-02

“The Company‘s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018.” trevena.com ↗

“Trevena’s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018” trevena.com ↗

Filed US (FDA) OLINVO acute pain 2017-11-02

“recently submitted its New Drug Application (NDA) for OLINVO TM (oliceridine injection) to the U.S. Food and Drug Administration (FDA).” trevena.com ↗

“OLINVO™ (oliceridine) Injection New Drug Application submitted and accepted for review by FDA” trevena.com ↗

Trials 33

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 · 1 met primary
Phase 2 NCT02520297 Oct 2015 — Trevena Inc. Terminated No outcome recorded
Phase 2 NCT02335294 Dec 2014 → Jul 2015 — Trevena Inc. Completed Met primary
Phase 2 NCT02100748 Apr → Oct 2014 — Trevena Inc. Completed No outcome recorded
Phase 33 trials · 2 met primary
Phase 3 NCT02815709 May → Dec 2016 — Trevena Inc. Completed Met primary
Phase 3 NCT02820324 May → Dec 2016 — Trevena Inc. Completed Met primary
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 Recruiting 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 overdue — 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
Comparator or background therapy1 trial
Phase 4 NCT07306702 Background Jun 2026 → May 2027 — Shenyang Sixth People's Hospital Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 53

DateIssuerRelease
2023-06-26 Trevena Inc. Results Trevena Announces New Topline OLINVYK Data Highlighting Reduced Cost per Admission from ARTEMIS Real-World Outcomes Study trevena.com ↗
OLINVYK-treated patients (n=201) had a statistically significant ~$8,750 (19%) lower cost per admission and ~1.4 day (20%) reduced average length of hospital stay, compared to matched patients treated with other IV opioids (n=982)
2023-05-08 Trevena Inc. Regulatory Trevena Announces Approval of OLINVYK in China trevena.com ↗
today announced that its partner in China, Jiangsu Nhwa, received formal approval from the National Medical Products Administration for OLINVYK.
2023-03-30 Trevena Inc. Results Trevena Announces Initial Topline OLINVYK Data from ~200 Patient Real-World Clinical Outcomes Study trevena.com ↗
Over 90% of OLINVYK-treated patients in VOLITION reported feeling “alert and calm” from the morning of the first post-operative day and at every observation point thereafter, based on the Richmond Agitation-Sedation Scale
2023-03-30 Trevena Inc. Results Trevena Reports Fourth Quarter 2022 Results and Provides Business Update trevena.com ↗
Initial topline data from new real-world VOLITION study demonstrated over 50% GI complete response and less than 4% incidence of symptoms suggestive of delirium in patients treated with OLINVYK.
2023-02-14 Trevena Inc. Results Trevena Announces Publication of OLINVYK Respiratory Physiology Study In ANESTHESIOLOGY trevena.com ↗
The results of the study demonstrated that oliceridine and morphine differed in their pharmacodynamics with a more rapid onset and offset of respiratory depression for oliceridine and a smaller magnitude of respiratory depression over time.
2022-10-24 Trevena Inc. Results Trevena Announces OLINVYK Poster Presentation at the ANESTHESIOLOGY® 2022 Annual Meeting trevena.com ↗
These data add to our prior published work with oliceridine, and continue to suggest that it may provide a reduced impact on ventilatory function as compared to IV morphine.
2022-08-11 Trevena Inc. Results Trevena Reports Second Quarter 2022 Results and Provides Business Update trevena.com ↗
OLINVYK post-approval strategy advances with positive topline cognitive function data and continued enrollment in VOLITION clinical outcomes study
2022-07-28 Trevena Inc. Results Trevena Announces Positive Topline OLINVYK Cognitive Function Data and Provides General Business Update trevena.com ↗
Trevena, Inc. (Nasdaq:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported positive topline results from its post-approval study designed to assess the impact on cognitive function in subjects treated with OLINVYK compared to IV morphine.
2022-04-20 Trevena Inc. Results Trevena Announces Results from Respiratory Physiology Study of Head-to-Head Comparison of OLINVYK® and IV Morphine in Elderly/Overweight Subjects trevena.com ↗
These data suggest that OLINVYK, a new chemical entity, may offer a more favorable respiratory safety profile when compared to IV morphine.
2022-03-31 Trevena Inc. Results Trevena Reports Fourth Quarter and Full Year 2021 Results trevena.com ↗
Topline data of OLINVYK vs IV morphine in high-risk subjects demonstrates statistically significant benefit in lowering respiratory depression
2022-01-27 Trevena Inc. Regulatory Trevena Announces Submission of New Drug Application in China for OLINVYK® by its Partner Jiangsu Nhwa Pharmaceutical trevena.com ↗
today announced that China’s National Medical Products Administration (NMPA) has accepted submission of a New Drug Application (NDA) for oliceridine injection.
2021-10-13 Trevena Inc. Results Trevena Announces Two OLINVYK® Presentations at ANESTHESIOLOGY® 2021 trevena.com ↗
Obese patients (BMI > 30 kg/m 2 ) were not at an increased risk for developing ORAEs, despite having a higher incidence of medical comorbidities compared to

All press releases naming this drug 84 releases

DateIssuerRelease

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 ↗

NCT06409689 ↗

NCT02820324 ↗

NCT07026162 ↗

NCT07372209 ↗

NCT07479446 ↗

NCT07306702 ↗

NCT06411665 ↗

NCT05465226 ↗

NCT06619145 ↗

Show 16 more sources

Known as Oliceridina ChEMBL registry synonym — accepted as the source's own label CHEMBL2443262 ↗
Known as Oliceridine Fumarate “Drug: Oliceridine Fumarate” NCT06454292 ↗
Known as Oliceridine fumarate injection “Oliceridine fumarate injection” NCT06530563 ↗
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

NCT02100748 ↗

NCT02169934 ↗

NCT02344303 ↗

NCT02083315 ↗

NCT02335294 ↗

NCT02520297 ↗

NCT02656875 ↗

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 ↗