Data updated: May 26, 2026
BUPIVACAINE LIPOSOME (bupivacaine)
Trial Activity: Mature 2 active trials
Pain
Approved 2024-07-01
Development Insights
Icahn School of Medicine at Mount Sinai conducting 2 trials (20%)
18 indications explored (Broad Platform)
→ pulmonary nodule (1 trials)
→ liposomal bupivacaine (1 trials)
→ fibroid uterus (1 trials)
1
Indication
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2024-07-01
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE, LIPOSOMAL
BUPIVACAINE LIPOSOME Approval History
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2024
What BUPIVACAINE LIPOSOME Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2024)Letter
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Clinical Trial Registry
287 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340801 | R 762 | Ph 4 | completed | Inter-semispinal Fascial Plane Block (ISPB) Versus Erector Spinae Plane Block (ESPB) in Posterior Cervical Spine Surgery |
| NCT04864210 results posted | 201901777 | Ph 2 | completed | Video-assisted Thoracoscopic Surgery - Exparel Study |
| NCT05900427 | EH23-069 | Ph 4 | terminated | Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients |
| NCT03781388 results posted | Pro00101530 | Ph 4 | completed | ED90 for Hyperbaric Bupivacaine in Super Obese Parturients |
| NCT07512635 | Ming-Yi-Yuan-Ethics-2024-54/02 | Ph 4 | not yet recruiting | Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy |
| NCT05391971 | 22-00374 | Ph 4 | active not recruiting | Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder |
| NCT06743919 | OSCTAP Cholecystectomy | Ph 4 | completed | Adding Magnesium Sulfate or Dexmedetomidine to Bupivacaine in Oblique Subcostal Tap Block for Laparoscopic Cholecystectomy: A Randomized Double -Blind Controlled Study |
| NCT07469826 | F.2-81/22-GENL/275/JPMC | Ph 3 | completed | Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures |
| NCT07467356 | RC 18-2-2026 | Ph 3 | recruiting | Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries |
| NCT07465185 | RC 17-2-2026 | Ph 2 | recruiting | Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery |
| NCT06784180 | 23-3302 | Ph 4 | withdrawn | Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine |
| NCT03214510 | 2016-1111 NCI-2018-01124, 2016-1111 | Ph 3 | active not recruiting | Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery |
| NCT07430085 | 2025-344 | Ph 4 | not yet recruiting | Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA |
| NCT07280195 | 202509174 | Ph 4 | enrolling by invitation | ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty |
| NCT06002152 QoR-SCPB | 2000035991 No NIH funding | Ph 2 | completed | Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy |
| NCT06411795 | ANES-2023-31918 NCI-2024-02287, ANES-2023-31918 | Ph 2 | recruiting | Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy |
| NCT06997016 | Baylor IRB #025-220 | Ph 4 | enrolling by invitation | Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients |
| NCT06908837 | 2024-520204-26-00 | Ph 4 | completed | Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty |
| NCT07194694 DEX\KET in TAP | MD 42 | Ph 3 | completed | Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty |
| NCT02381353 | 14-007145 | Ph 4 | active not recruiting | Exparel Injection for Postoperative Orbital Pain |
| NCT07329582 | 2023/00591 | Ph 4 | active not recruiting | Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia |
| NCT06271265 | 402-C-125 | Ph 1 | recruiting | Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery |
| NCT07276906 NOA | 2387143-1 | Ph 4 | not yet recruiting | Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy |
| NCT03599635 results posted | ANES-2017-25584 | Ph 4 | completed | Pec Infiltration With Liposomal Bupivacaine for Breast Surgery |
| NCT04272086 | GCO 19-1807 | Ph 4 | completed | Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy |
| NCT06635889 | IRB24-1600 | Ph 2 | recruiting | Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain |
| NCT07221019 | NCR256547 | Ph 4 | recruiting | Single Shot Exparel vs Catheters in Lower Extremity Trauma |
| NCT06989866 | NMCP.2024.0031 | Ph 3 | enrolling by invitation | RCT to Test Regional Anesthesia Effect on Decreased Opiate Use |
| NCT05171179 | STU00214187 | Ph 3 | completed | The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery |
| NCT04979338 | STUDY00000879 | Ph 3 | recruiting | Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries |
| NCT07146685 RPRCT | 302714 | Ph 4 | not yet recruiting | Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study |
| NCT06291727 | Prisma Upstate | Ph 4 | completed | Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA |
| NCT03351348 | 17-576 | Ph 3 | recruiting | Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control |
| NCT05425979 | 22-000140 | Ph 4 | enrolling by invitation | Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks |
| NCT05017246 results posted | 202105007 | Ph 2 | terminated | Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy |
| NCT05732532 | 22-007855 | Ph 4 | completed | Steroids in Occipital Nerve Block for Treatment of Headache |
| NCT05992896 | 23-003451 | Ph 4 | terminated | A Study of Loco-Regional Liposomal Bupivacaine Injection |
| NCT06165679 | N-439-2023 | Ph 3 | completed | Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients |
| NCT07023991 | FMASU MS113/2025 | Ph 1 | enrolling by invitation | Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries |
| NCT07013955 FESS (Function | 1465/02/2025 | Ph 3 | enrolling by invitation | Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization |
| NCT03737292 | 10129 | Ph 4 | recruiting | Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy |
| NCT05972681 PAIN | 2023-14825 | Ph 4 | recruiting | The PAIN (Pelvic Area Injection for Numbness) Study |
| NCT05357690 | 22-001106 | Ph 2, Ph 3 | recruiting | A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation |
| NCT06935669 TFBP | FMASU MD36/2025 | Ph 1 | not yet recruiting | Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block |
| NCT06120530 results posted | 17120 | Ph 4 | completed | Intraperitoneal Bupivacaine for Pelvic Organ Prolapse |
| NCT05068960 | IRB-19-7479 | Ph 4 | completed | Postoperative Pain Control in Total Shoulder Arthroplasty |
| NCT05456490 | 402-C-124 | Ph 1 | completed | Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered Via a Single Intrathecal Injection to Healthy Volunteers |
| NCT05664958 results posted | Pro00112152 | Ph 4 | completed | ESP Block for Post Cesarean Analgesia |
| NCT06789393 | B+D hypospadias repair surgery | Ph 3 | not yet recruiting | Comparison of the Efficacy of Bupivacaine with and Without Dexmedetomidine As an Adjuvant on Penile Block for Postoperative Pain Relief in Pediatrics Undergoing Hypospadias Repair Surgery |
| NCT06789575 | Wound Infilt/InstThyroid Surg | Ph 3 | not yet recruiting | Comparison of Bupivacaine Wound Infiltration Versus Wound Instillation to Minimize Postoperative Pain After Thyroid Surgery |
Showing 50 of 287 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
BUPIVACAINE LIPOSOME FDA Label Details
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Data Sources
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