CLINICAL TRIALS PROFILE FOR EXPAREL

505(b)(2) Clinical Trials for Exparel

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Atrium Health Levine Cancer Institute	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

All Clinical Trials for Exparel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00485433 ↗	Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair	Completed	Pacira Pharmaceuticals, Inc	Phase 2	2007-06-01	The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
NCT00485693 ↗	Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty	Completed	Pacira Pharmaceuticals, Inc	Phase 2	2007-06-01	Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
NCT00529126 ↗	Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy	Completed	Pacira Pharmaceuticals, Inc	Phase 2	2007-09-01	Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.
NCT00813111 ↗	Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation	Terminated	Pacira Pharmaceuticals, Inc	Phase 3	2008-11-01	The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Clinical Trial Conditions for Exparel

Condition Name

Condition Name for Exparel
Intervention	Trials
Pain, Postoperative	47
Pain	32
Postoperative Pain	31
Opioid Use	14

Condition MeSH

Condition MeSH for Exparel
Intervention	Trials
Pain, Postoperative	109
Osteoarthritis	17
Rotator Cuff Injuries	13
Fractures, Bone	11

Clinical Trial Locations for Exparel

Trials by Country

Trials by Country for Exparel
Location	Trials
United States	390
Denmark	4
Hong Kong	3
Belgium	3
China	2

Trials by US State

Trials by US State for Exparel
Location	Trials
Texas	38
Ohio	36
New York	31
California	30
North Carolina	25

Clinical Trial Progress for Exparel

Clinical Trial Phase

Clinical Trial Phase for Exparel
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	6
PHASE2	3

Clinical Trial Status

Clinical Trial Status for Exparel
Clinical Trial Phase	Trials
Completed	114
Recruiting	57
Terminated	36

Clinical Trial Sponsors for Exparel

Sponsor Name

Sponsor Name for Exparel
Sponsor	Trials
Pacira Pharmaceuticals, Inc	65
Mayo Clinic	13
Rothman Institute Orthopaedics	8

Sponsor Type

Sponsor Type for Exparel
Sponsor	Trials
Other	289
Industry	72
U.S. Fed	7

Exparel Market Analysis and Financial Projection

Last updated: April 25, 2026

What is the current clinical and market trajectory for Exparel (bupivacaine liposome injectable suspension), and what does the outlook indicate?

What is Exparel (bupivacaine liposome injectable suspension) and where is it used clinically?

Exparel is a long-acting local anesthetic formulated as bupivacaine encapsulated in multivesicular liposomes. It is marketed for postsurgical analgesia in settings where sustained local anesthesia reduces pain and opioid use.

Indications (US labeling, at a high level)

• Postsurgical local analgesia, including infiltration and surgical-site local anesthesia approaches (label scope depends on surgical context and administration technique).

Core clinical positioning

• Single-administration, extended-release local anesthetic designed to provide analgesia beyond immediate-release bupivacaine.

Note: The most decision-relevant clinical trial updates depend on the specific development pipeline and trial registry activity by sponsor and geography. The provided prompt does not include a trial identifier, geography, or sponsor context, and a complete update requires that specificity.

---

What clinical trial activity matters for a market update in Exparel?

A credible clinical update for Exparel requires tracking:

• New Phase 3 registrational trials (or label-expansion studies tied to the original active ingredient and formulation)
• Post-approval studies designed to support expanded surgical indications, new administration techniques, or comparative effectiveness
• Safety-focused trials or pharmacovigilance analyses that affect reimbursement, formulary decisions, or risk management requirements

What can be stated from the drug-level identifier alone

• Exparel is an established, approved product; the market impact of “clinical trials update” in an established local anesthetic category is typically driven by incremental label expansion, regimen refinement (dose and injection techniques), and comparative studies vs alternatives (bupivacaine formulations, ropivacaine, nerve blocks, multimodal analgesia protocols).

What cannot be completed from the provided prompt

• Specific, date-stamped trial results, endpoints, and enrollment numbers for the last 12 to 24 months
• Registry citations (ClinicalTrials.gov IDs), publication citations, and regulatory filings tied to trial milestones

Under the operating constraints, producing a “clinical trials update” without the trial set and its sources would be incomplete.

---

What is the market reality for Exparel: drivers, constraints, and competitive pressure?

Exparel’s market is shaped by:

• Demand for reduced postoperative pain and opioid minimization (hospital and payer protocols)
• Adoption patterns for surgical analgesia pathways (multimodal protocols, ERAS uptake)
• Competitive alternatives including:
  • Other long-acting local anesthetics (and their clinical protocols)
  • Regional anesthesia approaches (nerve blocks, catheter-based strategies)
  • Multimodal analgesia protocols that reduce reliance on any single local anesthetic product

Key commercial mechanics

• Formularies and contracting: conversion from “surgeon preference” to “system standard” drives repeat volume
• Operating room workflows: time, dosing, preparation, and administration technique influence adoption
• Payer coverage: local anesthetic products often face contracting dynamics that can be more material than headline clinical outcomes

What most affects near-term growth

• Evidence that the regimen improves outcomes that payers and hospitals measure (pain scores, opioid consumption, discharge time, PACU metrics)
• Data supporting ease of integration into perioperative pathways
• Label expansion into higher-volume surgical segments or administration approaches

---

What does a defensible market projection require for Exparel?

A defensible projection requires at least:

• Current category and product revenue base (by geography, channel, and time period)
• Measured share trends vs competitive products and approaches
• Conversion metrics (utilization growth, contracting displacement)
• Pricing and volume elasticity assumptions
• Any new label changes or new evidence that shifts adoption curves

What cannot be completed from the provided prompt

• A quantitative projection (CAGR, revenue in $ and year-by-year) with an auditable basis
• A trial-to-market causality map for the “clinical trials update” claim
• Up-to-date competitive landscape metrics by product and year

Under the operating constraints, producing numbers or a forecast without sourced inputs would violate completeness.

---

Key Takeaways

• Exparel is an established long-acting local anesthetic positioned for postsurgical analgesia; market adoption depends on hospital protocol fit, contracting, and evidence that improves payer-relevant outcomes.
• A “clinical trials update” and a “market analysis and projection” require specific, sourced trial and commercial datasets; those are not provided in the prompt.
• With the current input, the only accurate high-level conclusion is that Exparel’s near-term trajectory depends on incremental clinical evidence that changes utilization and formulary inclusion, alongside competitive displacement dynamics in perioperative pain management.

---

FAQs

1) Is Exparel still an active focus for new clinical development?

It remains an approved product; whether new Phase 3 or label-expansion trials are ongoing depends on current registry and publication activity by sponsor and geography, which is not specified in the prompt.

2) What endpoints usually drive adoption of long-acting local anesthetics like Exparel?

Pain scores over time, opioid consumption, and operational metrics such as PACU recovery or discharge-related outcomes, tied to perioperative protocols.

3) How do competing strategies reduce Exparel utilization?

Hospitals may shift to alternative long-acting local anesthetics, different local anesthetic formulations, or regional anesthesia pathways that meet analgesia targets with different workflow and cost profiles.

4) What commercial factor usually matters most: price or volume?

Both, but contracting and utilization conversion (system standardization and formulary inclusion) often determine volume more directly for perioperative products.

5) What is the first data source to build an Exparel market projection?

A time-series revenue baseline by geography and channel, aligned to utilization and contracting trends, plus evidence milestones that change the adoption curve.

---

References

[1] FDA. “Exparel (bupivacaine liposome injectable suspension) Prescribing Information.” (Accessed via FDA labeling repository).