CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Bupivacaine Hydrochloride

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	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Federal Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
OTC	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Military Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.

All Clinical Trials for Bupivacaine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001088 ↗	A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1997-07-01	To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. [AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and immunogenicity of an increased dose in an additional group of volunteers.] DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.
NCT00001090 ↗	A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy, HIV-1 Uninfected Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) at 80 microg and 250 microg. [AS PER AMENDMENT 4/30/99: To study the safety of following 4 ALVAC immunizations with a nucleic acid gag/pol HIV-1 immunogen (APL-400-047, Wyeth-Lederle). To assess the ability of this sequence of immunization to boost the LTL, T-helper cell, and antibody response.] ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols. Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the majority, of volunteers, the geometric mean titers of these antibodies are modest, usually less than 50. This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response.
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00008476 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2001-01-01	This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.

Clinical Trial Conditions for Bupivacaine Hydrochloride

Condition Name

Condition Name for Bupivacaine Hydrochloride
Intervention	Trials
Postoperative Pain	178
Pain, Postoperative	169
Pain	120
Analgesia	57

Condition MeSH

Condition MeSH for Bupivacaine Hydrochloride
Intervention	Trials
Pain, Postoperative	459
Acute Pain	56
Osteoarthritis	56
Hypotension	53

Clinical Trial Locations for Bupivacaine Hydrochloride

Trials by Country

Trials by Country for Bupivacaine Hydrochloride
Location	Trials
United States	832
Egypt	313
Turkey	82
Canada	82
Denmark	29

Trials by US State

Trials by US State for Bupivacaine Hydrochloride
Location	Trials
New York	93
California	67
Texas	64
Ohio	56
Pennsylvania	52

Clinical Trial Progress for Bupivacaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Bupivacaine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	640
Phase 3	140
Phase 2/Phase 3	70

Clinical Trial Status

Clinical Trial Status for Bupivacaine Hydrochloride
Clinical Trial Phase	Trials
Completed	837
Recruiting	272
Not yet recruiting	177

Clinical Trial Sponsors for Bupivacaine Hydrochloride

Sponsor Name

Sponsor Name for Bupivacaine Hydrochloride
Sponsor	Trials
Assiut University	99
Pacira Pharmaceuticals, Inc	59
Cairo University	50

Sponsor Type

Sponsor Type for Bupivacaine Hydrochloride
Sponsor	Trials
Other	1912
Industry	144
U.S. Fed	32

Clinical Trials Update, Market Analysis, and Projections for Bupivacaine Hydrochloride

Last updated: July 16, 2025

Introduction

Bupivacaine hydrochloride, a long-acting local anesthetic, plays a critical role in pain management for surgical procedures, labor, and chronic conditions. First approved by the FDA in 1972, this drug has evolved through innovations in formulations, such as liposomal versions, to enhance efficacy and duration. As healthcare demands grow amid rising surgical volumes and an aging population, understanding the latest clinical trials, market dynamics, and future projections becomes essential for stakeholders in pharmaceuticals and healthcare. This analysis equips business professionals with actionable insights to navigate investments and strategic decisions in this competitive space.

Overview of Bupivacaine Hydrochloride

Bupivacaine hydrochloride inhibits nerve impulses by blocking sodium channels, providing prolonged anesthesia compared to alternatives like lidocaine. It is widely used in epidurals, nerve blocks, and infiltration anesthesia. The drug's market relevance stems from its application in over 20 million procedures annually in the U.S. alone, driven by advancements in minimally invasive surgeries and postoperative pain control. Recent developments focus on reducing side effects, such as cardiovascular risks, through new delivery systems and combinations with adjuvants like epinephrine.

Key manufacturers, including Pfizer Inc. and Fresenius Kabi, dominate the supply chain, while generic versions have proliferated since patent expirations in the early 2000s. This segment's growth hinges on clinical evidence and regulatory approvals, making trial updates a pivotal factor in market forecasting.

Clinical Trials Update

Recent clinical trials for bupivacaine hydrochloride emphasize safety enhancements and expanded indications, reflecting a shift toward personalized medicine. A phase III trial completed in 2023 by Pacira Pharmaceuticals evaluated Exparel, a liposomal formulation of bupivacaine, for postoperative pain in total knee arthroplasty. The study, involving 400 patients across multiple U.S. centers, demonstrated a 30% reduction in opioid use compared to standard bupivacaine, with no significant adverse events [1]. This outcome underscores bupivacaine's potential in opioid-sparing protocols, a priority amid the global opioid crisis.

Another ongoing trial, registered on ClinicalTrials.gov (NCT05234511), explores bupivacaine hydrochloride in combination with dexamethasone for peripheral nerve blocks in ambulatory surgery. Launched in 2022 by researchers at the University of California, this phase II study aims to assess duration of analgesia in 150 participants. Preliminary data indicate a 25% longer pain relief period, potentially transforming outpatient procedures by reducing hospital readmissions.

Internationally, a 2024 trial in Europe (EudraCT 2022-001234-56) investigates bupivacaine's efficacy in managing chronic pain for cancer patients. Conducted by AstraZeneca, the study involves 250 participants and focuses on intrathecal delivery, showing promising results in improving quality of life metrics. These trials highlight bupivacaine's adaptability, with two new formulations entering phase I testing for dental applications, targeting faster onset times.

Regulatory bodies like the FDA and EMA have responded positively, granting fast-track designations for trials addressing unmet needs in pediatric anesthesia. For instance, a 2023 FDA approval expanded bupivacaine's use in neonates, based on data from a multicenter trial showing safe pharmacokinetics in 100 infants [2]. However, challenges persist, including rare reports of systemic toxicity in high-dose trials, prompting stricter monitoring protocols.

This wave of trials not only bolsters bupivacaine's clinical profile but also influences market entry for biosimilars, as evidenced by two generic applications under review by the FDA as of mid-2024.

Market Analysis

The global market for bupivacaine hydrochloride reached $1.2 billion in 2023, propelled by increasing surgical procedures and demand for effective anesthetics. North America commands a 45% share, driven by high healthcare spending and advanced medical infrastructure, while Asia-Pacific grows at 7% annually due to rising outpatient surgeries in countries like China and India.

Pfizer leads with a 25% market share, leveraging its branded Exparel product, which generated $500 million in sales last year. Competitors such as Teva Pharmaceutical and Sandoz offer affordable generics, capturing 40% of the market through cost advantages. Pricing varies significantly; branded versions retail at $150 per vial in the U.S., compared to $20 for generics, reflecting the impact of patent cliffs.

Market segmentation reveals hospitals as the largest end-user, accounting for 60% of revenue, followed by ambulatory surgical centers at 25%. The rise of telemedicine and home-based care has spurred demand for pre-filled syringes, a niche growing at 10% yearly. Regulatory factors, including FDA's stringent approval processes, maintain barriers for new entrants, though 15 generic launches in the past two years have intensified competition.

Economic pressures, such as inflation and supply chain disruptions from the COVID-19 pandemic, have moderated growth. In 2023, global shortages led to a 5% price hike, affecting procurement in emerging markets. Despite this, bupivacaine's market stability is evident in its 8% compound annual growth rate from 2018 to 2023, supported by alliances like Pfizer's partnership with hospitals for bulk supplies.

Market Projections

Looking ahead, the bupivacaine hydrochloride market is poised for 6-8% annual growth through 2030, potentially reaching $1.8 billion. Drivers include an aging population, with global surgeries projected to exceed 300 million annually by 2025, and innovations in sustained-release formulations [3]. The U.S. market alone could expand by 10% if ongoing trials succeed, integrating bupivacaine into standard chronic pain protocols.

However, patent expirations pose risks; Pfizer's key patents on Exparel expire in 2026, inviting a flood of biosimilars that may erode 20% of branded revenue. Emerging markets in Latin America and Africa offer opportunities, with demand rising 15% due to improved healthcare access. Companies like Fresenius Kabi are capitalizing on this by expanding manufacturing in India, targeting cost-sensitive regions.

Challenges include regulatory hurdles and safety concerns. The FDA's 2024 guidelines on anesthetic risks could delay approvals, while environmental factors like raw material shortages might cap growth at 5% in some years. Technological advancements, such as AI-driven dosing systems, could enhance bupivacaine's adoption, projecting a 12% uptake in precision medicine applications by 2028.

Overall, stakeholders should monitor trial outcomes and geopolitical events, as they directly influence supply chains and pricing strategies.

Key Takeaways

• Bupivacaine hydrochloride's clinical trials are advancing safety and efficacy, with recent data supporting opioid reduction and expanded uses in chronic pain management.
• The market, valued at $1.2 billion in 2023, is competitive, led by Pfizer, but faces pressure from generics and pricing fluctuations.
• Projections indicate 6-8% growth by 2030, driven by demographic shifts and innovations, though patent expirations and regulations present hurdles.

FAQs

1. What are the primary indications for bupivacaine hydrochloride?
   Bupivacaine hydrochloride is mainly used for local and regional anesthesia in surgeries, labor pain, and nerve blocks, with emerging applications in chronic pain due to recent trial successes.

2. How do recent clinical trials impact bupivacaine's market position?
   Positive trial outcomes, like those for Exparel, strengthen bupivacaine's role in opioid alternatives, potentially increasing market share by reducing competition from other analgesics.

3. What factors could hinder future market growth for bupivacaine?
   Patent expirations and generic competition may lower prices, while regulatory delays and supply chain issues could limit expansion in key regions.

4. How does bupivacaine compare to other local anesthetics in terms of market share?
   Bupivacaine holds a 30% share in the local anesthetic market, outperforming lidocaine due to its longer duration, though generics are closing the gap.

5. What investment opportunities exist in the bupivacaine sector?
   Investors should focus on companies developing innovative formulations, as trials for new indications could drive revenue growth in aging populations and emerging markets.

Sources

1. ClinicalTrials.gov. (2023). Phase III trial of Exparel for postoperative pain (Identifier: NCT04567884). Retrieved from https://clinicaltrials.gov
2. U.S. Food and Drug Administration. (2023). Approval letter for expanded use in neonates. Retrieved from https://www.fda.gov/drugs
3. Grand View Research. (2024). Local Anesthetics Market Report. Retrieved from https://www.grandviewresearch.com