Last reviewed 2026-04-20 · How we verify

Olinvyk (OLICERIDINE)

Olinvyk works by binding to the mu-type opioid receptor in the brain, which helps to reduce the perception of pain.

Olinvyk (Oliceridine) is a small molecule modality developed by Trevena Inc, targeting the mu-type opioid receptor. It was FDA-approved in 2020 for the treatment of moderate and severe pain. As a patented product with no generic manufacturers, Olinvyk maintains its commercial exclusivity. Key safety considerations include its potential for dependence and abuse, similar to other opioids. Olinvyk's exact pharmacokinetic properties, such as half-life and bioavailability, are not publicly disclosed.

At a glance

Mechanism of action

Oliceridine is full opioid agonist and is relatively selective for the mu-opioid receptor. The principal therapeutic action of oliceridine is analgesia. Like all full opioid agonists, there is no ceiling effect to analgesia for oliceridine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory, and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play role in the analgesic effects of this drug.

Approved indications

• Moderate pain
• Severe pain

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OLINVYK Addiction, Abuse, and Misuse Because the use of OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of OLINVYK are essential [see Warnings and Precautions ( 5.2 )]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of OLINVYK and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. Neonatal Opioid Withdrawal Syndrome Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions ( 5.4 )]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OLINVYK See full prescribing information for complete boxed warning. OLINVYK exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and reassess regularly for the development of behaviors or conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of OLINVYK are essential. ( 5.2 ) Concomitant use of OLINVYK with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.4 , 7 ) Advise pregnant women using opioids for an extended period of time of the risks of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.3 )

Common side effects

• Nausea
• Vomiting
• Dizziness
• Headache
• Constipation
• Pruritus
• Hypoxia

Serious adverse events

• Hypotension
• Hypoventilation
• Oxygen saturation decreased
• Alanine aminotransferase increased
• Aspartate aminotransferase increased
• Electrocardiogram QT prolongation
• Urticaria

Key clinical trials

• Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery (NA)
• Effects and Safety of Oliceridine in Anesthesia Induction:A Randomised Controlled Trial (NA)
• The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy (PHASE4)
• Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy (NA)
• Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients (PHASE4)
• Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery (NA)
• Oliceridine Dose for Tracheal Intubation Hemodynamic Elevation: Up-and-Down Trial (NA)
• Intravenous Oliceridine and Opioid-related Complications (PHASE4)

Patents

Primary sources

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