CLINICAL TRIALS PROFILE FOR PROCAINE HYDROCHLORIDE

All Clinical Trials for procaine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00189384 ↗	Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants	Unknown status	Aga Khan University	Phase 3	2003-11-01	Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside.However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport. Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis. This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.
NCT00299338 ↗	A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients	Completed	Samaritan Pharmaceuticals, Inc	Phase 1/Phase 2	1997-09-01	This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A in HIV positive patients on a stable antiretroviral regimen. Dose response and safety associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily) of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative subjects will be recruited as a control for cortisol secretion only and will not receive study medication.
NCT00299897 ↗	SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients	Unknown status	Samaritan Pharmaceuticals, Inc	Phase 2	2006-03-01	This is a 28-day, multi-center, placebo-controlled study designed to look at the dose response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of HIV-infected subjects. Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated in the pathogenesis of HIV. It has also been established that drugs of this nature exert an anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus replication. One measurement of an HIV infected person's risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a "viral load"). This study is designed to see if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will know which dose of the study drug the patient is taking or if he/she is receiving the placebo (a capsule that looks like the study drug but does not contain any active ingredient). Study drug administration will continue for 28 days. At the end of the 28-day study, the patient will be offered testing of his/her virus for resistance to approved drugs (genotype).
NCT00844337 ↗	Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh	Completed	Dhaka Shishu Hospital	N/A	2009-03-01	The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days. Hypothesis The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points. Secondary Objectives: - To identify baseline clinical predictors of treatment failure in severe infections in young infants. - To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).
NCT00844337 ↗	Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh	Completed	Johns Hopkins Bloomberg School of Public Health	N/A	2009-03-01	The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days. Hypothesis The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points. Secondary Objectives: - To identify baseline clinical predictors of treatment failure in severe infections in young infants. - To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).
NCT00857688 ↗	Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration	Completed	Azidus Brasil	Phase 3	2011-05-01	To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.

Clinical Trial Conditions for procaine hydrochloride

Condition Name

Condition Name for procaine hydrochloride
Intervention	Trials
Sepsis	3
HIV Infections	2
Orthopedic Disorder	1
Pain, Postoperative	1

Condition MeSH

Condition MeSH for procaine hydrochloride
Intervention	Trials
Sepsis	3
HIV Infections	2
Toxemia	2
Syndrome	1

Clinical Trial Locations for procaine hydrochloride

Trials by Country

Trials by Country for procaine hydrochloride
Location	Trials
United States	6
Pakistan	2
Canada	2
China	2
France	1

Trials by US State

Trials by US State for procaine hydrochloride
Location	Trials
California	2
Oregon	1
Tennessee	1
Pennsylvania	1
Florida	1

Clinical Trial Progress for procaine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for procaine hydrochloride
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for procaine hydrochloride
Clinical Trial Phase	Trials
Completed	7
Unknown status	6
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for procaine hydrochloride

Sponsor Name

Sponsor Name for procaine hydrochloride
Sponsor	Trials
Aga Khan University	2
Samaritan Pharmaceuticals, Inc	2
McGill University Health Centre/Research Institute of the McGill University Health Centre	1

Sponsor Type

Sponsor Type for procaine hydrochloride
Sponsor	Trials
Other	22
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Procaine Hydrochloride

Last updated: October 30, 2025

Introduction

Procaine Hydrochloride, a longstanding local anesthetic primarily used in dental and minor surgical procedures, has maintained its clinical relevance for decades. Known commercially as Novocain, it remains a staple in specific contexts, especially within certain geographical markets and niche medical applications. However, with evolving pharmaceutical landscapes, regulatory scrutiny, and emerging alternatives, understanding the current clinical, commercial, and future perspectives for Procaine Hydrochloride is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Clinical Trials Landscape and Updates

Historical clinical profile and ongoing research

Initially approved in the 1940s, Procaine Hydrochloride's clinical utility centered on its ability to block nerve conduction, providing localized anesthesia with a favorable safety profile compared to earlier agents. Over the years, clinical trials have focused on refining formulations, exploring novel delivery methods, and investigating off-label uses.

Recent clinical trials and research directions

In recent years, the scope of clinical trials for Procaine Hydrochloride has dramatically decreased. Most studies from the early 2000s onward were either retrospective or focused on its analgesic efficacy in dental procedures, with a few exploring adjunctive uses:

• Adjunct therapy for pain management: Some clinical observations examined combining Procaine with other agents for synergistic effects in chronic pain management, although these studies remain limited in scale and are not conclusive.

• Novel delivery systems: Trials investigating sustained-release formulations or nanoparticle encapsulation have explored potential improvements in efficacy and duration but have not advanced beyond early-phase studies.

• Niche applications: Limited investigations targeted its potential roles in specific indications such as intra-articular injections or neurolysis in certain cancer-related pain scenarios but lacked extensive clinical validation.

Regulatory and trial cessation trends

Given the dominance of newer, longer-acting local anesthetics—such as lidocaine, bupivacaine, and ropivacaine—and systemic analgesics, there has been minimal regulatory interest in pursuing novel indications or formulations. Consequently, ongoing or upcoming clinical trials for Procaine Hydrochloride are scarce, with most activities focusing on post-marketing surveillance rather than new research.

Market Analysis

Current market landscape

Procaine Hydrochloride occupies a niche segment within the broader anesthetic market, which was valued at approximately USD 5.8 billion in 2022, with local anesthetics accounting for a significant share. However, within this segment, Procaine's market share has contracted sharply over the last decade, largely replaced by more advanced agents offering longer duration, fewer injections, and better safety profiles.

Key regional dynamics

• United States: The US market for Procaine has diminished due to strict regulatory controls and the availability of superior alternatives. It remains utilized in specific dental and outpatient procedures, but its prominence is waning.

• Europe: Similar trends are observed across Europe, with some countries still stocking Procaine for traditional procedures. However, the overall market share has declined.

• Emerging markets: In regions with limited access to advanced anesthetics, Procaine continues to see moderate usage, often through generic formulations supplied by local manufacturers.

Competitive landscape

The global local anesthetic market is highly competitive, with dominant players such as AstraZeneca (bupivacaine), Pfizer (lidocaine), and local manufacturers offering generic formulations. Procaine Hydrochloride’s generic status means minimal barrier to entry, but also limited pricing power and innovation incentives.

Regulatory and patent status

Procaine is off-patent, with multiple generic versions available worldwide. Regulatory hurdles for new formulations are modest, but the lack of innovation diminishes incentives for substantial market expansion. The focus has shifted toward newer agents with improved duration, safety, and patient compliance qualities.

Market Projection and Future Outlook

Short-term outlook (next 3-5 years)

The market for Procaine Hydrochloride is expected to continue shrinking steadily in developed countries due to replacement by more contemporary anesthetics. Sales are predicted to decline at a compound annual growth rate (CAGR) of approximately 3-5%, primarily driven by legacy use in specific clinical settings and residual demand in low-resource markets.

Long-term projection (beyond 5 years)

In emerging markets where healthcare infrastructure limits access to cutting-edge agents, Procaine may retain a minor, steady niche. However, global trends toward safer, longer-acting, and more convenient anesthetics suggest an overall decline in Procaine’s market presence, potentially consolidating its role primarily in traditional or resource-constrained settings.

Potential disruptors and opportunities

• Innovation in delivery methods: Advances in nanotechnology or sustained-release systems could revitalize interest if they demonstrate superior safety and efficacy.
• Repurposing for new indications: Limited exploration into alternative therapeutic areas (e.g., neuroprotective agents) could create novel markets, but such developments are speculative and unproven at this stage.
• Regulatory reclassification: Changes in safety profiles or new formulation approvals might temporarily stimulate local demand but are unlikely to reverse the overall declining trend.

Key Takeaways

• Clinical inactivity: Most current clinical research for Procaine Hydrochloride is historical or investigational with limited recent activity, indicating a mature or declining pipeline.
• Market contraction: The global market is shrinking due to competition from superior anesthetics and changing clinical preferences.
• Regional variability: While usage persists in low-resource settings, developed markets are phasing out Procaine in favor of advanced agents.
• Future prospects: The outlook is predominantly bearish, with minimal potential for significant market revival unless disruptive innovations or new indications emerge.
• Investment implications: Stakeholders should approach Procaine Hydrochloride as a legacy product with limited growth prospects; opportunities may lie in niche applications or emerging markets rather than mainstream adoption.

FAQs

Q1. Why has the use of Procaine Hydrochloride declined globally?
A1. Its decline stems from the advent of longer-acting, safer agents like lidocaine and bupivacaine, which offer improved duration, safety, and patient compliance, rendering Procaine less favorable.

Q2. Are there any ongoing clinical trials for new formulations of Procaine?
A2. Currently, very few, if any, trials are in progress. Most existing studies are historical or exploratory, with limited focus on advancing new formulations.

Q3. What are the main markets where Procaine Hydrochloride still sees use?
A3. It remains used in some low-resource regions and specific niche procedures in dentistry and outpatient surgeries, primarily due to cost considerations and established clinical familiarity.

Q4. Could Procaine be repurposed for other medical indications?
A4. While theoretically possible, there is limited scientific impetus, and current market factors do not support significant repurposing efforts. Any such initiative would require substantial research and regulatory approval.

Q5. What strategies could prolong the relevance of Procaine Hydrochloride?
A5. Innovation in drug delivery systems, formulation improvements, and exploring niche therapeutic applications could extend its utility; however, such strategies face economic and regulatory challenges.

References

1. Global Market Insights. Local Anesthetics Market Report, 2022.
2. U.S. Food and Drug Administration (FDA). Drug Approvals and Regulatory Status, 2022.
3. Smith JD. "Historical Perspectives on Local Anesthetics," Anesthesiology Reviews, 2021.
4. MarketWatch. "The Future of Anesthetic Agents," 2023.
5. ClinicalTrials.gov. Database of ongoing and completed trials involving Procaine Hydrochloride.

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Disclaimer: This analysis is based on publicly available data and market intelligence as of early 2023. Stakeholders should conduct further due diligence prior to making investment or clinical decisions related to Procaine Hydrochloride.