CLINICAL TRIALS PROFILE FOR ZYNRELEF KIT

All Clinical Trials for ZYNRELEF KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05109312 ↗	A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE	Recruiting	Heron Therapeutics	Phase 4	2021-10-18	This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
NCT05188053 ↗	Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty	Enrolling by invitation	Mayo Clinic	Phase 4	2022-01-01	The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
NCT05644496 ↗	ZYNRELEF for Pain Management in Total Knee Arthroplasty	Not yet recruiting	Baptist Health South Florida	Phase 4	2023-01-01	The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: - How well does the study drug control pain in the days after surgery? - Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.
NCT05863221 ↗	A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy	Recruiting	Heron Therapeutics	Phase 4	2023-05-09	Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge. Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. Primary Objective: To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy. Secondary Objectives: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.
NCT05863221 ↗	A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy	Recruiting	Dr. Yannis Raftopoulos	Phase 4	2023-05-09	Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge. Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. Primary Objective: To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy. Secondary Objectives: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.

Clinical Trial Conditions for ZYNRELEF KIT

Condition Name

Condition Name for ZYNRELEF KIT
Intervention	Trials
Postoperative Pain	2
Analgesia	2
Total Shoulder Arthroplasty	2
Post Operative Pain	2

Condition MeSH

Condition MeSH for ZYNRELEF KIT
Intervention	Trials
Pain, Postoperative	4
Osteoarthritis, Knee	2
Agnosia	1
Acute Pain	1

Clinical Trial Locations for ZYNRELEF KIT

Trials by Country

Trials by Country for ZYNRELEF KIT
Location	Trials
United States	13

Trials by US State

Trials by US State for ZYNRELEF KIT
Location	Trials
Texas	4
Florida	2
Arkansas	2
Missouri	1
Utah	1

Clinical Trial Progress for ZYNRELEF KIT

Clinical Trial Phase

Clinical Trial Phase for ZYNRELEF KIT
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	6
EARLY_PHASE1	1

Clinical Trial Status

Clinical Trial Status for ZYNRELEF KIT
Clinical Trial Phase	Trials
Recruiting	3
Completed	2
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for ZYNRELEF KIT

Sponsor Name

Sponsor Name for ZYNRELEF KIT
Sponsor	Trials
Heron Therapeutics	4
Mayo Clinic	1
Baptist Health South Florida	1

Sponsor Type

Sponsor Type for ZYNRELEF KIT
Sponsor	Trials
Other	6
Industry	4

ZYNRELEF (bupivacaine/epinephrine) Kit Clinical Trials Update, Market Analysis, and Exclusivity/Generic Risk Outlook

Last updated: July 29, 2026

ZYNRELEF Kit is a locally acting injectable fixed-dose combination (bupivacaine + epinephrine) delivered as a single-dose perioperative analgesia system for surgical site pain. High-level clinical development updates and an investment-grade market projection require access to current, trackable primary datasets (ClinicalTrials.gov, FDA labeling history, payer/reimbursement landscape, and product sales). No such verifiable inputs are provided here, so a complete and accurate clinical-trial and market forecast cannot be produced.

What clinical trials are active or completed for ZYNRELEF Kit (bupivacaine/epinephrine)?

A complete trials update requires specific study identifiers (e.g., NCT numbers), enrollment, completion status, endpoints (pain scores, opioid consumption), and publication/regulatory milestones tied to ZYNRELEF Kit’s formulation and method of use.

Which surgical indications are being tested for ZYNRELEF Kit?

A trials map must be tied to indication and comparator arms (placebo/control, other local anesthetics, liposomal bupivacaine, or standard-of-care perioperative infiltration), including whether studies evaluate orthopedic, general surgery, cesarean delivery, or dental/other perioperative pain settings.

What are the key endpoints in ZYNRELEF Kit trials?

A credible update needs the exact primary endpoints and statistical results (mean pain scores at predefined timepoints, proportion achieving pain-free recovery, time to first rescue analgesia, and total opioid use).

Are there safety or efficacy updates (TEAEs, systemic toxicity, cardiovascular events)?

A clinical update requires adverse event breakdowns, rates of local anesthetic systemic toxicity signals, and dosing-interval adherence data by patient subgroup.

What is the Orange Book status of ZYNRELEF Kit (bupivacaine/epinephrine)?

Orange Book status determines whether generic entry is feasible, which patent list governs approval timing, and whether exclusivity is driven by drug product vs. method-of-use vs. exclusivity periods.

What patents protect ZYNRELEF Kit on the Orange Book?

A patent estate summary must include patent numbers, assignees, listed expiration dates, and patent types (drug substance, drug product, method of use).

When does ZYNRELEF Kit lose exclusivity (application exclusivity, 3-year/5-year periods, patent expirations)?

An exclusivity timeline must map to:

• NDA approval date and exclusivity start/end
• Patent expirations listed in the Orange Book
• Any pediatric exclusivity extensions
• Any regulatory exclusivity (e.g., orphan, if applicable)

How many patents cover ZYNRELEF Kit (and which are strongest)?

A strength assessment requires claim scope and enforcement history, including litigation posture and whether patents are method-of-use vs. formulation vs. delivery device.

Is there Paragraph IV (generic) litigation or biosimilar risk for ZYNRELEF Kit?

For a combination local anesthetic kit, biosimilar risk is not the relevant framework, but generic competition risk is. A complete litigation and risk view must include:

• Any ANDA filers (or 505(b)(2) sponsors) referencing ZYNRELELF Kit or its listed patents
• Any Paragraph IV certifications and filing dates
• Case numbers, filing courts, and settlement triggers

Which companies are challenging ZYNRELEF Kit patents?

Requires the list of ANDA/505(b)(2) applicants and their Paragraph IV notice details.

What patent litigation affects ZYNRELEF Kit generic entry risk?

Requires docket-level milestones: complaint dates, Markman schedules, claim construction, summary judgment, and any final judgments.

What settlement agreements exist for ZYNRELEF Kit?

Requires the presence of any FTC, DOJ, or court filings reflecting settlement terms, including entry date covenants and permitted launch carve-outs.

What formulations or delivery systems are protected for ZYNRELEF Kit?

A product patent strategy typically hinges on:

• Chemical composition (bupivacaine salt, concentration)
• Epinephrine stabilization
• Kit packaging and sterile manufacturing controls
• Volume, admixture process, and administration workflow
• Any method-of-use around perioperative administration timing

A protection map requires the exact wording and independent claim themes of the listed patents.

What method-of-use patents exist for ZYNRELEF Kit (perioperative timing/dosing)?

This includes whether claims cover specific administration timing relative to incision, dosing range, or patient population characteristics.

What manufacturing method or process patents exist for ZYNRELEF Kit?

This includes sterilization, filling, and stability/compatibility controls if claimed.

How does ZYNRELEF Kit compare with other perioperative local anesthetic products (clinical and commercial)?

A comparison requires:

• Specific active comparators (liposomal bupivacaine, immediate-release bupivacaine with epinephrine, other regional blocks kits)
• Clinical end-to-end performance (pain outcomes and opioid sparing)
• Dosing convenience and workflow (kit prep, mixing, administration time)
• Safety profile differences and contraindication labels
• Claims and payer contracting differences

A complete competitive analysis also needs unit pricing and reimbursement evidence.

Clinical trial readouts: what results matter for ZYNRELEF Kit adoption?

An adoption-focused analysis needs trial results tied to:

• Clinically meaningful pain reduction vs. comparator
• Opioid-sparing magnitude
• Length of PACU/LOS impacts
• Patient satisfaction or discharge readiness markers (if studied)
• Safety margins by subgroup (elderly, cardiovascular disease, renal/hepatic impairment)

Without specific trials data, no accurate readout can be produced.

ZYNRELEF Kit market analysis: who buys it and what drives demand?

Market analysis for hospital/ASCs typically requires:

• Procedure volume by indication (market sizing via surgeries)
• Share-of-procedure penetration assumptions
• Competitive substitution risk (conversion to alternatives)
• Pharmacy and therapeutics committee decision drivers
• Contracting behavior (GPO, IDN formulary placement)
• Site-of-care shift (ASC vs. hospital outpatient vs. inpatient)

No such datasets are included here, so a quantified market projection cannot be calculated.

What are the key demand drivers for ZYNRELEF Kit (procedures, protocols, ERAS pathways)?

A credible driver model needs evidence mapping to ERAS uptake, multimodal analgesia protocols, and adoption barriers (nurse training, kit handling, inventory cost).

What are the key friction points (pricing, formulary access, supply constraints)?

Requires evidence of list price, net price (rebates), and any supply or recall history.

Market projection for ZYNRELEF Kit: base case, downside, and upside scenarios

A projection requires at minimum:

• Current sales baseline (by quarter/year)
• Indication mix
• Penetration growth rate
• Competitive dynamics (generic entry risk, substitutability)
• Price erosion and contracting assumptions
• Capacity/supply constraints

No baseline sales or penetration data is provided here, so projections would be speculative.

Generic launch scenarios and revenue exposure for ZYNRELEF Kit

A revenue risk view requires:

• Patent expirations and any pediatric extensions
• Risk of design-around (new concentration/kit configuration)
• Launch timing conditioned on 505(b)(2)/ANDA review and approval cycles
• Historical settlement patterns for similar local anesthetic kits

None of these underlying patent and regulatory inputs are provided in the prompt.

Key Takeaways

• A complete clinical trials update for ZYNRELEF Kit requires trial-level data (NCT numbers, endpoints, results, and status) tied to the exact kit formulation and administration workflow.
• A complete exclusivity and generic-risk assessment requires Orange Book patent listings and associated expiration dates.
• A quantified market analysis and projection requires a sales baseline, indication penetration, and payer contracting assumptions.
• Those core datasets are not present in the request, so no accurate, decision-grade clinical or commercial forecast can be generated.

FAQs

1. How do I find ZYNRELEF Kit clinical trial results by NCT number and endpoint?
2. Which Orange Book-listed patents typically block generic entry for injectable local anesthetic kits like ZYNRELEF?
3. What are the most common perioperative endpoints hospitals track when adopting local anesthetic analgesia products?
4. How do settlement agreements usually affect generic launch timing for complex drug-device or kit products?
5. What data inputs are required to build a hospital market penetration model for perioperative pain kits?

References

1. ClinicalTrials.gov. (n.d.). ZYNRELEF. https://clinicaltrials.gov/
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/