Olinvyk

(Oliceridine)

ApprovedSmall molecule

Olinvyk is a small molecule that works as a Mu Opioid Receptor Agonist.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Olinvyk is one of 133 small molecule programs targeting Pain. It is currently in Approved.

Indications

Total Trials

Active Trials

132

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic PainActive, not recruiting

Nausea and VomitingRecruiting

StrabismusActive, not recruiting

Postoperative AnalgesiaRecruiting

Colorectal SurgeryCompleted

Chronic Post-Surgical PainRecruiting

Tracheal IntubationCompleted

Randomised Controlled TrialCompleted

Thyroid DiseaseActive, not recruiting

Chronic PainApproved

Active, not recruiting

Nausea and VomitingApproved

Recruiting

StrabismusPreclinical

Active, not recruiting

Postoperative AnalgesiaPreclinical

Recruiting

Colorectal SurgeryApproved

Completed

Chronic Post-Surgical PainApproved

Recruiting

Tracheal IntubationPreclinical

Completed

Randomised Controlled TrialPreclinical

Completed

Thyroid DiseasePreclinical

Active, not recruiting

Competition

Competitive Landscape

78 competitors in Nausea and Vomiting

#DrugCompanyPhaseTrials

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

38 2

Olinvyk

TTrevena Inc.

Approved

1 3

Xylocaine

MMEDRx USA, Inc.

Approved

1 4

Marcaine

IInnocoll

Approved

1 5

Thalomid

Bristol-Myers Squibb

Phase 3

2 6

Abraxane

Bristol-Myers Squibb

Phase 3

1 7

Gemzar

Johnson & Johnson

Phase 3

1 8

Megace

Bristol-Myers Squibb

Phase 3

1 9

Nereus

VVanda Pharmaceuticals

Phase 3

2 10

HSK21542

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

ApprovedRecruiting

Chronic Post-Surgical Pain

NCT07018375

Q3 2027

N/ANot yet recruiting

Nausea

NCT07479446

Q4 2029

Not yet recruiting

Obstructive Sleep Apnea

NCT07753785

Clinical

Trials by Indication[1]

Oliceridine3 trials

Oliceridine in Patients With Acute Burn Injuries

Completed·UUniversity of Tennessee·Phase 4·NCT05465226·31 enrolled

Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Completed·TTrevena Inc.·Phase 3·NCT02815709·418 enrolled

Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

Not yet recruiting·HHenan Provincial People's Hospital·N/A·NCT07097038·120 enrolled

Postoperative Analgesia2 trials

Clinical Study of G Protein Biased Μ - Opioid Receptor Agonist Oliceridine for Optimizing Postoperative Analgesia Under General Anesthesia

Not yet recruiting·HHenan Provincial People's Hospital·N/A·NCT06668298·150 enrolled

Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

Recruiting·—·N/A·NCT06990893·90 enrolled

Dexmedetomidine1 trial

Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients

Completed·SShenyang Sixth People's Hospital·Phase 4·NCT07306702·102 enrolled

Randomised Controlled Trial1 trial

Effects and Safety of Oliceridine in Anesthesia Induction:A Randomised Controlled Trial

Completed·—·N/A·NCT07372209·120 enrolled

Efficacy and Safety1 trial

To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain

Completed·YYuwei Qiu·Phase 4·NCT06458400·75 enrolled

15 more indications

Strabismus1 trial

Efficacy of Oxalidine and Sufentanil in Strabismus Correction

Not yet recruiting·HHenan Provincial People's Hospital·N/A·NCT07112157·290 enrolled

Oliceridine Fumarate1 trial

the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery

Not yet recruiting·XXiangya Hospital of Central South University·Phase 4·NCT06530563·606 enrolled

Tracheal Intubation1 trial

Oliceridine Dose for Tracheal Intubation Hemodynamic Elevation: Up-and-Down Trial

Completed·SShiyou Wei·N/A·NCT07154979·58 enrolled

Nausea and vomiting1 trial

Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

Recruiting·YYanYing Xiao·Phase 4·NCT07026162·96 enrolled

Nausea1 trial

Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

Not yet recruiting·XXuanwu Hospital, Beijing·N/A·NCT07479446·174 enrolled

Complication1 trial

Intravenous Oliceridine and Opioid-related Complications

Completed·TThe Cleveland Clinic·Phase 4·NCT04979247·111 enrolled

Abdominoplasty1 trial

Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty

Completed·TTrevena Inc.·Phase 3·NCT02820324·407 enrolled

Hyperalgesia1 trial

Oliceridine for Remifentanil-Induced Postoperative Hyperalgesia

Completed·XXingguo Xu·Approved·NCT07913555·130 enrolled

Hypotension1 trial

Effects of Oliceridine and Sufentanil on Post-Induction Hypotension in Patients Undergoing Gynecological Abdominal Surgery

Completed·XXingguo Xu·Approved·NCT07871500·134 enrolled

Hypoxemia During Surgery1 trial

Respiratory Safety of Oliceridine in Propofol-Sedated Gastrointestinal Endoscopy: A Double-Blind, Randomized Controlled Trial

Completed·SShiyou Wei·Preclinical·NCT07187765·508 enrolled

Chronic Post-surgical Pain1 trial

Effect of Oliceridine-based Intravenous Patient-Controlled Analgesia on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lung Resection: A Multicenter Randomized Double-Blind Controlled Trial Protocol

Recruiting·TTianjin Medical University General Hospital·Approved·NCT07018375·320 enrolled

Obstructive Sleep Apnea1 trial

Effects of Oliceridine Versus Sufentanil Analgesia on Incidence of Postoperative Respiratory Depression in Patients at High-Risk of Obstructive Sleep Apnea: A Prospective Cohort Study

Not yet recruiting·PPeking University First Hospital··NCT07753785·851 enrolled

Cough1 trial

Oliceridine vs Sufentanil for Cough During General Anesthesia Induction: A Randomized Controlled Trial

Recruiting·SShiyou Wei·Approved·NCT07660380·62 enrolled

Hysteroscopy1 trial

Efficacy and Safety of the Biased μ-Opioid Receptor Agonist Oliceridine in Hysteroscopic Procedures

Completed·TTangshan Maternal and Child Health Hospital·Preclinical·NCT07713134·225 enrolled

Colorectal Surgery1 trial

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery: A Randomized Trial

Completed·PPeking University First Hospital·Approved·NCT06411665·252 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 30, 2020

OLINVYK

NDA NDA210730

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Oliceridine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oliceridine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oliceridine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210730). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Olinvyk. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Trevena Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mu Opioid Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: TTrevena Inc.

Patent Landscape[5]

Patent Cliff

Mar 23, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11931350Mar 23, 2032

9642842Mar 23, 2032

8835488Mar 23, 2032

9309234Mar 23, 2032

11077098Mar 23, 2032

Olinvyk

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2029

Trials by Indication[1]

Oliceridine3 trials

Postoperative Analgesia2 trials

Dexmedetomidine1 trial

Randomised Controlled Trial1 trial

Efficacy and Safety1 trial

Strabismus1 trial

Oliceridine Fumarate1 trial

Tracheal Intubation1 trial

Nausea and vomiting1 trial

Nausea1 trial

Complication1 trial

Abdominoplasty1 trial

Hyperalgesia1 trial

Hypotension1 trial

Hypoxemia During Surgery1 trial

Chronic Post-surgical Pain1 trial

Obstructive Sleep Apnea1 trial

Cough1 trial

Hysteroscopy1 trial

Colorectal Surgery1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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