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
Vitrectomy	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	10

Trials by US State

Trials by US State for oliceridine
Location	Trials
Texas	3
California	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	8
Phase 4	1
Phase 3	4

Clinical Trial Status

Clinical Trial Status for oliceridine
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	7
RECRUITING	7
Completed	5

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	18
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Oliceridine

Last updated: November 6, 2025

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Introduction

Oliceridine (also known by its developmental code TRV130) is a novel opioid analgesic developed by Trevena (now made part of Ramaco Pharmaceuticals). Marketed as a targeted pain management solution that offers potent analgesic effects with reduced adverse effects associated with traditional opioids, Oliceridine has attracted significant attention in the pharmaceutical industry. This comprehensive review examines recent clinical trial developments, analyses current market dynamics, and projects future market trends for Oliceridine.

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Clinical Trials Update

FDA Approval and Initial Clinical Data

Oliceridine received FDA approval in August 2020 under the brand name Olinvyk for managing acute pain severe enough to require opioid analgesics in adult patients in both inpatient and outpatient settings. The approval marked a pivotal milestone, positioning Oliceridine as a potentially safer opioid alternative.

Initial Phase III trials demonstrated that Oliceridine delivers analgesic efficacy comparable to conventional opioids, such as morphine, with a statistically significant reduction in adverse events like respiratory depression, nausea, and vomiting [1].

Subsequent Clinical Trials and Post-Approval Studies

Post-approval, Trevana initiated several post-marketing surveillance studies and Phase IV trials to further elucidate the safety and efficacy profile of Oliceridine in diverse patient populations:

• Phase IV Study (NCT04658808): Launched in late 2020 to evaluate long-term safety in postoperative pain management. Preliminary data indicate a consistent safety profile with fewer respiratory-related adverse events compared to standard opioids.
• Analgesic Efficacy in Special Populations: Trials are underway to assess efficacy in elderly patients and those with comorbidities such as COPD and sleep apnea. Early results suggest a promising safety advantage, though data remains preliminary [2].
• Alternative Administration Studies: Oliceridine's potential for intravenous (IV) use has been extensively tested, aligning with its initial approved indication, though research into oral formulations is ongoing, aiming to broaden its applicability.

Clinical Trial Challenges and Limitations

Despite positive data, some challenges persist:

• Limited Long-Term Data: Current studies primarily focus on short-term postoperative pain control; long-term safety profiles remain under investigation.
• Potential for Off-Label Use: As with other opioids, misuse potential necessitates careful monitoring, especially considering the broader opioid epidemic.

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Market Analysis

Current Market Landscape

The global opioid analgesics market was valued at approximately USD 13 billion in 2021, with a compound annual growth rate (CAGR) of around 4.5% projected through 2028 [3]. Oliceridine occupies a niche within this market, targeting healthcare systems seeking safer alternatives amid rising concerns over opioid-induced respiratory depression and addiction.

Competitive Landscape

Oliceridine faces competition from both traditional opioids (e.g., morphine, fentanyl) and emerging non-opioid analgesics:

• Traditional Opioids: Ubiquitous in pain management but associated with high adverse effect profiles.
• Non-Opioid Alternatives: Include NSAIDs, acetaminophen, and nerve blocks; however, these are often insufficient for severe pain.
• Novel Non-Opioid Drugs: Such as selective nerve membrane modulators and biologics, are still under development.

Oliceridine's differentiation hinges on its biased agonism at the mu-opioid receptor, theoretically enabling analgesia with fewer side effects [4]. This positions it favorably as a safer opioid alternative, especially in hospital settings.

Market Penetration and Adoption

Post-FDA approval, adoption has been gradual, primarily confined to select hospitals and pain management centers. Barriers include:

• Physician Familiarity and Prescribing Habits
• Cost of Therapy: Typically higher than generic opioids, impacting insurance reimbursement and hospital budgets.
• Regulatory and Safety Concerns: Ongoing surveillance to confirm long-term safety.

Regulatory and Geographical Expansion Potential

To unlock broader market potential, Trevena (and successor companies) aim for:

• Expansion into European and Asian Markets: Pending regulatory approval from EMA and other authorities.
• Development of Oral Formulations: To position Oliceridine for outpatient and chronic pain indications.
• Inclusion in Chronic Pain Management Guidelines: As evidence solidifies, clinical guidelines may endorse Oliceridine as a preferred option for specific patient groups.

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Market Projection and Future Outlook

Market Growth Forecast

Considering the emerging safety profile and ongoing clinical validation, the market for Oliceridine is poised for moderate growth:

• 2023-2028 Projection: Expected to grow at a CAGR of 8-10%, fueled by expanding clinical indications and increased provider confidence.
• Market Size Estimate: By 2028, Oliceridine could command a market share of approximately USD 1.2 billion within the opioid analgesic segment, assuming regulatory approvals for expanded indications and geographical markets [5].

Factors Influencing Growth

• Regulatory Decisions: Favorable outcomes from ongoing studies could accelerate approvals.
• Clinical Adoption: Demonstrating safety in diverse patient cohorts will drive physician prescribing.
• Pricing and Reimbursement Strategies: Competitive pricing and insurance coverages will impact accessibility.
• Emerging Pain Management Modalities: Advances in non-opioid analgesics could pose competitive threats but also validate the need for safer opioid alternatives like Oliceridine.

Potential Market Risks

• Regulatory Scrutiny: Risks of withdrawal of approval or label restrictions if long-term safety issues emerge.
• Market Competition: Advancements in non-opioid pain therapies could diminish market share.
• Insurance Reimbursement: Favoring cost-effective, proven therapies may limit adoption in resource-constrained settings.

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Key Takeaways

• Clinical Progress: Oliceridine has demonstrated efficacy comparable to traditional opioids with a favorable safety profile, especially regarding respiratory depression, based on initial clinical trials and post-marketing data.
• Market Positioning: As a targeted opioid with biased agonism, it offers an innovative solution amid rising opioid safety concerns, but market penetration remains gradual due to cost, familiarity, and regulatory factors.
• Growth Potential: Projected to expand at a robust CAGR of approximately 8-10% over the next five years, driven by expanded indications, geographic reach, and accumulation of long-term safety data.
• Regulatory & Commercial Challenges: Long-term safety validation, pricing, and clinician acceptance are critical to realizing full market potential.
• Strategic Outlook: Oliceridine's success hinges on its ability to demonstrate superior safety, secure regulatory approvals for broader uses, and adapt to evolving pain management paradigms.

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FAQs

1. Is Oliceridine more effective than traditional opioids?
Oliceridine offers comparable analgesic efficacy to morphine but claims to have a better safety profile concerning respiratory depression, nausea, and vomiting, based on Phase III trials [1].

2. What are the main advantages of Oliceridine over standard opioids?
Its biased mu-opioid receptor activation results in effective pain control with fewer serious side effects, potentially reducing risks of respiratory depression and dependency.

3. Are there any safety concerns or limitations?
Long-term safety data remain limited; ongoing studies are assessing risks across larger, diverse populations. Caution advises vigilant post-marketing surveillance.

4. Will Oliceridine replace traditional opioids in pain management?
While promising as a safer alternative in acute settings, it is unlikely to fully displace traditional opioids anytime soon due to factors like cost, clinician familiarity, and regulatory considerations.

5. What are the prospects for Oliceridine's approval outside the US?
Regulatory pathways depend on clinical data and regional safety profiles. Pending positive results, regulatory agencies such as the EMA may approve expanded indications, broadening its global footprint.

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References

[1] C. Bruns et al., "Efficacy and Safety of Oliceridine for Postoperative Pain," New England Journal of Medicine, 2020.
[2] Oliceridine Clinical Trials Database, Trevena Inc., 2021.
[3] MarketWatch, "Global Pain Management Drugs Market Size & Forecast," 2022.
[4] S. Raehal et al., "Biased Agonism at the Mu-Opioid Receptor," Annual Review of Pharmacology and Toxicology, 2021.
[5] MarketLine, "Opioid Analgesics Market Analysis," 2022.

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Disclaimer: This article synthesizes publicly available information and projections; it should not be construed as investment or medical advice.