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Oliceridine Injection [Olinvyk]
Oliceridine is a mu-opioid receptor agonist that binds selectively to mu-opioid receptors to produce analgesia for acute pain management.
Oliceridine (Olinvyk) is a selective mu-opioid receptor agonist developed by Trevena and approved by the FDA in 2020 for moderate to severe acute pain in hospitalized patients. The drug represents a novel biased agonist approach, activating G-protein signaling pathways while minimizing β-arrestin recruitment, theoretically reducing respiratory depression and other opioid-related adverse effects compared to traditional mu-agonists. Currently marketed as an intravenous injection formulation (1 mg/mL in 1 mL, 2 mL, and 30 mL vials), Oliceridine addresses a critical unmet need in acute perioperative and postoperative pain management where rapid onset and reduced respiratory risk are clinically valuable. Recent publications from 2025 demonstrate ongoing clinical research into optimal dosing for intubation prevention and day-case surgical procedures, indicating continued clinical development. Commercial uptake has been modest relative to initial expectations, with peak sales estimates below $100M annually, reflecting competitive pressure from established opioids and non-opioid alternatives. The drug's differentiation lies in its biased signaling mechanism and potential safety profile, though real-world adoption remains limited by formulary restrictions, reimbursement challenges, and physician familiarity with traditional opioid analgesics.
At a glance
| Generic name | Oliceridine Injection [Olinvyk] |
|---|---|
| Also known as | Oliceridine fumarate injection, H20233508 |
| Sponsor | Xiangya Hospital of Central South University |
| Drug class | Mu-opioid receptor agonist |
| Target | Mu-opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Oliceridine activates mu-opioid receptors in the central and peripheral nervous system, inhibiting pain signal transmission and producing analgesic effects. As a G-protein biased mu-opioid agonist, it preferentially activates G-protein signaling pathways over beta-arrestin pathways, which may contribute to a potentially improved safety profile compared to traditional opioids.
Approved indications
- Acute pain management in hospitalized patients
Common side effects
- Nausea
- Dizziness
- Vomiting
- Headache
- Respiratory depression