CLINICAL TRIALS PROFILE FOR OLICERIDINE

All Clinical Trials for OLICERIDINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02656875 ↗	A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain	Completed	Trevena Inc.	Phase 3	2015-12-01	Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days.
NCT02815709 ↗	Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy	Completed	Trevena Inc.	Phase 3	2016-05-01	The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.
NCT02820324 ↗	Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty	Completed	Trevena Inc.	Phase 3	2016-05-01	The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.
NCT04979247 ↗	Intravenous Oliceridine and Opioid-related Complications	Recruiting	The Cleveland Clinic	Phase 3	2021-09-15	The investigator will evaluate the side effects of oliceridine.
NCT05465226 ↗	Oliceridine in Patients With Acute Burn Injuries	Not yet recruiting	Trevena Inc.	Phase 4	2022-08-01	Pain after acute burn injury is complex with much still not understood. The primary mechanism is believed to be nociceptive, but is interwoven with aspects of somatogenic, neuropathic, and psychogenic pathways. As such, opioid receptor agonists are an essential component for pain management after burn injury. The majority of wound care and dressing changes are completed in non-intubated patients and rates of respiratory depression concerning. Oliceridine is a biased, selective MOR agonist approved for treatment of acute pain. To date there is no literature of use in patients with burn injuries. While it should be effective, efficacy and the potential for reduced adverse events need to be quantified. Current practice and guidelines, plead for better analgesia for patients with burn injuries.
NCT05465226 ↗	Oliceridine in Patients With Acute Burn Injuries	Not yet recruiting	University of Tennessee	Phase 4	2022-08-01	Pain after acute burn injury is complex with much still not understood. The primary mechanism is believed to be nociceptive, but is interwoven with aspects of somatogenic, neuropathic, and psychogenic pathways. As such, opioid receptor agonists are an essential component for pain management after burn injury. The majority of wound care and dressing changes are completed in non-intubated patients and rates of respiratory depression concerning. Oliceridine is a biased, selective MOR agonist approved for treatment of acute pain. To date there is no literature of use in patients with burn injuries. While it should be effective, efficacy and the potential for reduced adverse events need to be quantified. Current practice and guidelines, plead for better analgesia for patients with burn injuries.
NCT06320041 ↗	Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery	RECRUITING	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	PHASE4	2024-08-01	The goal of this clinical trial\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice. Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose.

Clinical Trial Conditions for OLICERIDINE

Condition Name

Condition Name for OLICERIDINE
Intervention	Trials
Acute Pain	5
Oliceridine	3
Analgesia	2
Postoperative Pain Management	1

Condition MeSH

Condition MeSH for OLICERIDINE
Intervention	Trials
Acute Pain	5
Postoperative Nausea and Vomiting	3
Agnosia	3
Pain, Postoperative	2

Clinical Trial Locations for OLICERIDINE

Trials by Country

Trials by Country for OLICERIDINE
Location	Trials
United States	19
China	11

Trials by US State

Trials by US State for OLICERIDINE
Location	Trials
California	3
Texas	3
Maryland	2
Arizona	2
Utah	2

Clinical Trial Progress for OLICERIDINE

Clinical Trial Phase

Clinical Trial Phase for OLICERIDINE
Clinical Trial Phase	Trials
PHASE4	9
Phase 4	1
Phase 3	4

Clinical Trial Status

Clinical Trial Status for OLICERIDINE
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	8
Recruiting	7
Completed	6

Clinical Trial Sponsors for OLICERIDINE

Sponsor Name

Sponsor Name for OLICERIDINE
Sponsor	Trials
Trevena Inc.	4
Henan Provincial People's Hospital	3
Shiyou Wei	2

Sponsor Type

Sponsor Type for OLICERIDINE
Sponsor	Trials
Other	20
Industry	4

OLICERIDINE Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the current status of clinical trials for oliceridine?

Oliceridine (trade name: Olinvyk) is an opioid receptor agonist developed by Trevena Inc., intended for intravenous pain management. Its clinical development included multiple phases, primarily focusing on acute pain in hospital settings.

Clinical trial phases:

• Phase 1: Conducted to assess safety, pharmacokinetics, and dosing parameters.
• Phase 2: Evaluated efficacy and side effects in moderate to severe pain.
• Phase 3: Confirmed safety and efficacy in larger, diverse patient populations.

Recent developments:

• The FDA approved oliceridine in August 2020 for use in medical settings for moderate to severe pain.
• Post-approval trials included real-world safety and efficacy assessments.
• Ongoing observational studies monitor long-term safety, especially regarding respiratory depression and addiction potential compared to traditional opioids.

Key delay factors:

• Limited competitiveness due to existing opioids and opioid-sparing strategies.
• Concerns over regulatory scrutiny, given opioid addiction issues.
• Market hesitance driven by the opioid crisis and alternative pain management modalities.

How does oliceridine compare to traditional opioids in clinical outcomes?

Efficacy:

• Oliceridine provides rapid analgesia comparable to morphine.
• Studies demonstrate similar pain reduction profiles in controlled settings.

Safety profile:

• Exhibits reduced respiratory depression in clinical trials versus morphine.
• Shows a lower incidence of nausea and vomiting.
• Tolerance potential remains under study; concerns about long-term dependence exist.

Limitations:

• Limited data on chronic use.
• Cost of drug exceeds traditional opioids due to novel mechanism and regulatory costs.
• Not indicated for outpatient or long-term pain management.

What is the current market landscape for oliceridine?

The global opioid analgesics market was valued at approximately USD 11.3 billion in 2022 and is projected to grow at a CAGR of 3.5% from 2023 to 2030.

Competitive positioning:

Manufacturer	Key Drugs	Market Share (2022)	Differentiators
Pfizer	Morphine, fentanyl	25%	Established, broad indication spectrum
Purdue Pharma	Oxycodone, hydrocodone	20%	Long-standing market presence
Trevena	Oliceridine	<1%	Novel mechanism targeting safety

Market entry barriers:

• Existing familiarity and entrenched supply chains.
• Prescriber caution due to opioid dependency concerns.
• Regulatory hurdles, as detailed below.

Regulatory environment:

• FDA approval granted in 2020 for inpatient use.
• Pending or withdrawn applications in some jurisdictions due to safety concerns.
• Emphasis on risk mitigation and post-marketing surveillance.

What are the projections for oliceridine's market potential?

Market penetration estimates:

• Initial adoption limited to hospitals and pain clinics.
• Expected to capture 2-4% of the acute pain segment within five years post-market entry.
• High-quality data and cost reductions could expand indications.

Factors influencing growth:

• Enhanced safety profiles may drive hospital adoption.
• Advocacy for opioid-sparing approaches increases acceptance.
• However, competition from non-opioid analgesics, such as NSAIDs and nerve blocks, limits aggressive gains.

Financial forecasts:

• Analysts project peak sales of USD 200-300 million in the 2027-2028 window, assuming widespread adoption.
• Overly optimistic projections are tempered by safety concerns and market reticence.

What regulatory and commercial challenges could impact future growth?

Regulatory hurdles:

• Need for extensive safety data to offset opioid-related dependency fears.
• Potential restrictions on labeling or distribution.

Market barriers:

• Prescriber familiarity with established opioids.
• Pricing strategies favoring traditional drugs.
• Reimbursement policies that favor cost-effective options.

Legal risks:

• Ongoing litigation related to opioids overall but less specific to oliceridine.

Key Takeaways

• Oliceridine received FDA approval in 2020 for hospital use in acute pain.
• Clinical trials demonstrate effective analgesia with a potentially improved safety profile relative to morphine.
• Market penetration remains modest, constrained by existing opioids, regulatory concerns, and market inertia.
• Projections suggest limited peak sales unless safety advantages robustly translate into increased prescriber acceptance.
• Competition from established opioids and non-opioid alternatives remains a significant barrier.

FAQs

1. Is oliceridine approved for outpatient use?
No. It is approved strictly for hospital-based intravenous analgesia in moderate to severe pain.

2. How does oliceridine’s safety profile differ from morphine?
Clinical trials indicate lower rates of respiratory depression and nausea, with ongoing studies assessing long-term dependence risk.

3. What are the main barriers to market expansion?
Regulatory scrutiny, clinician familiarity with traditional opioids, cost, and competing non-opioid therapies.

4. Can oliceridine replace existing opioids?
Current data suggest it is unlikely to replace traditional opioids broadly but may serve as an alternative in specific inpatient settings due to its safety profile.

5. What future developments could influence oliceridine's market?
New formulations, expanded indications, and clearer safety data could enhance adoption; however, market dynamics favor well-established drugs unless substantial advantages emerge.

---

Sources:
[1] FDA Oliceridine approval press release, 2020.
[2] Market analysis reports, 2022-2023.
[3] Clinical trial registries and Trevena Inc. disclosures.