ZYNRELEF KIT (bupivacaine)
Bupivacaine is an amide local anesthetic used to provide numbness or pain relief during surgical, dental, and diagnostic procedures. It helps adult patients manage pain by creating local or regional anesthesia in specific areas of the body. This medication is also used for pain management during obstetrical procedures, such as childbirth.
How ZYNRELEF KIT Works
This medication works by blocking the generation and conduction of nerve impulses, which raises the threshold needed for electrical excitation in the nerves. By slowing the propagation of these signals and reducing the action potential's rate of rise, it prevents the transmission of sensations including pain, temperature, and touch.
Details
- Status
- Prescription
- First Approved
- 2021-05-12
- Patent Cliff
- 2036
- Routes
- PERIARTICULAR
- Dosage Forms
- SOLUTION, EXTENDED RELEASE
ZYNRELEF KIT Approval History
What ZYNRELEF KIT Treats
2 indicationsZYNRELEF KIT is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anesthesia
- Analgesia
ZYNRELEF KIT Boxed Warning
RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred afte...
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary ( 5.1 ).
ZYNRELEF KIT Competitive Set
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Indication competitors
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Drugs Similar to ZYNRELEF KIT
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Clinical Trial Registry
281 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 |
| 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 |
| 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 |
| NCT06752525 | SPGB sinus surgery | Ph 4 | not yet recruiting | Opioid Sparing Effect of Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: a Randomized Controlled Clinical Trial. |
| NCT04156581 ESPB-Spine results posted | 2019-1282 | Ph 4 | completed | Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery |
Showing 50 of 281 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ZYNRELEF KIT FDA Label Details
Indications & Usage
FDA Label (PDF)ZYNRELEF KIT is indicated for the treatment of Anesthesia; Analgesia.
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, ...
ZYNRELEF KIT Patents & Exclusivity
Patents (16 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 256 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.