TheraRadar
Data updated: May 26, 2026

OLINVYK (oliceridine)

Trial Activity: Mature 3 active trials
Fast Track
Pain Approved 2020-08-07
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Trevena Inc. conducting 2 trials (22%)
13 indications explored (Broad Platform)
→ acute pain (3 trials)
→ postoperative pain management (1 trials)
→ chronic postsurgical pain (1 trials)
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-08-07
Patent Cliff
2032

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

TREVENA
Active Ingredient: OLICERIDINE

OLINVYK Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2020 to 2025
Dec 2025 SUPPL
Label · Labeling
FDA Letter Label
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label
Mar 2021 SUPPL
Label · Labeling
FDA Letter Label

What OLINVYK Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
📋

Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT07306702 DEX-PCIA SYCHS6-LOB-PCIA-RCT-2023 JUH-CCP-RC-RETRO-01 Ph 4 withdrawn Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients
NCT07018375 IRB2025-YX-199-01 Ph 4 not yet recruiting The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy
NCT04979247 results posted 21-684 Ph 4 completed Intravenous Oliceridine and Opioid-related Complications
NCT07026162 LYEC2024-0425 Ph 4 recruiting Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery
NCT06458400 TGRD-ANAL-PILOT-001 Ph 4 completed To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
NCT06411665 2024-073 Ph 4 recruiting Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting
NCT05465226 RELIEVE 22-08748-FB Ph 4 completed Oliceridine in Patients With Acute Burn Injuries
NCT02820324 results posted CP130-3002 Ph 3 completed Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
NCT02815709 APOLLO-1 results posted CP130-3001 Ph 3 completed Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OLINVYK FDA Label Details

View full patent landscape →
5 OB patents · 1 families · 80 international docs across 25 countries

OLINVYK Patents & Exclusivity

Latest Patent: Mar 2032

Patents (5 active)

US11931350 Expires Mar 23, 2032
US9642842 Expires Mar 23, 2032
US8835488 Expires Mar 23, 2032
US9309234 Expires Mar 23, 2032
US11077098 Expires Mar 23, 2032
Source: FDA Orange Book

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Deep insights for OLINVYK

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2032
  • • 45 active patents

Trial Analysis

  • • 9 total trials
  • • Stage: Mature

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA210730 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment