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Last Updated: December 19, 2025

CLINICAL TRIALS PROFILE FOR CEFTRIAXONE SODIUM; LIDOCAINE


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All Clinical Trials for ceftriaxone sodium; lidocaine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03587441 ↗ Intrathecal Neostigmine for Prevention of PDPH Completed Fayoum University Hospital Phase 4 2018-08-04 Neuraxial blocks continue to be the cornerstone of anesthesia and postoperative analgesia for normal vaginal delivery and elective caesarean section due to its approved safety and efficiency for decades. Post-dural puncture headache (PDPH) is still one of the most common complications of neuraxial anesthetic techniques. The headache could be severe and limit the activities of the new mother to care for her baby, prolong hospital stay. PDPH is defined as a headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character. Neostigmine methylsulfate is a synthetic carbamic acid ester which reversibly inhibits the enzyme Acetylcholine esterase (AChE) that makes more Acetylcholine molecules available at cholinergic receptors. Neostigmine is used in anesthesia mainly as a reversal for non-depolarizing neuromuscular agents. Intrathecal (IT) neostigmine was tried as an adjuvant to local anesthetics in IT block for elective cesarean sections to decrease local anesthetic consumption and to prolong postoperative analgesia. Side effects of IT neostigmine are dose-dependent with doses more than 25 µg especially nausea and vomiting and could be decreased by increasing the baricities of the local anesthetic solutions and by early head up position after IT injection. However, its effect on PDPH was not investigated before in literature. Parturients will be randomly assigned into one of two groups: the intervention group will receive 20 µg with IT Bupivacaine and the control group will receive an equivalent volume of dextrose 5% with the IT Bupivacaine. The objective of the current study is to evaluate the efficacy and safety of IT neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.
NCT03853096 ↗ P.Acnes Colony Count Following Subdermal Cefazolin Unknown status University of British Columbia Early Phase 1 2019-04-01 The specific outcome is to determine whether the colony count of Propionibacterium acnes, one of the commonest causes of shoulder infection and not eradicated by conventional forms of surgical preparatory solutions and antibiotics, in a shoulder surgical wound will be altered by the use of subdermal cefazolin.
NCT06631625 ↗ Effect of Addition of Dexmedetomidine or Ketamine to Intravenous Infusion of Lidocaine on Proinflammatory Cytokines in Pelvi-abdominal Cancer Surgeries. COMPLETED Alexandria University PHASE1 2023-09-24 The investigators hypothesize that effect of addition of dexmedetomidine or ketamine by IV infusion to lidocaine infusion may be more beneficial than lidocaine infusion alone on proinflammatory cytokines (IL-1, IL-6 and TNF), and postoperative pain relief and decreased opioid consumption, reduced Length of stay.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ceftriaxone sodium; lidocaine

Condition Name

Condition Name for ceftriaxone sodium; lidocaine
Intervention Trials
Proinflammatory Cytokines 1
Surgery 1
Surgical Site Infection 1
Abdominal Cancer 1
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Condition MeSH

Condition MeSH for ceftriaxone sodium; lidocaine
Intervention Trials
Surgical Wound Infection 1
Infections 1
Infection 1
Communicable Diseases 1
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Clinical Trial Locations for ceftriaxone sodium; lidocaine

Trials by Country

Trials by Country for ceftriaxone sodium; lidocaine
Location Trials
Egypt 2
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Clinical Trial Progress for ceftriaxone sodium; lidocaine

Clinical Trial Phase

Clinical Trial Phase for ceftriaxone sodium; lidocaine
Clinical Trial Phase Trials
PHASE1 1
Phase 4 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for ceftriaxone sodium; lidocaine
Clinical Trial Phase Trials
COMPLETED 2
Unknown status 1
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Clinical Trial Sponsors for ceftriaxone sodium; lidocaine

Sponsor Name

Sponsor Name for ceftriaxone sodium; lidocaine
Sponsor Trials
Fayoum University Hospital 1
University of British Columbia 1
Alexandria University 1
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Sponsor Type

Sponsor Type for ceftriaxone sodium; lidocaine
Sponsor Trials
Other 3
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Clinical Trials Update, Market Analysis, and Projection for Ceftriaxone Sodium and Lidocaine

Last updated: November 3, 2025


Introduction

The pharmaceutical landscape consistently evolves as new data emerges from ongoing clinical trials, shaping market dynamics. Ceftriaxone sodium and lidocaine, two longstanding agents in infectious disease and anesthesia respectively, continue to attract attention for potential new indications, formulation developments, and market expansion strategies. This analysis offers a comprehensive overview of recent clinical trial updates, market trends, and future projections for these drugs.


Clinical Trials Update

Ceftriaxone Sodium

Ceftriaxone sodium, a third-generation cephalosporin antibiotic, remains pivotal in treating bacterial infections such as pneumonia, meningitis, and urinary tract infections. Recent clinical trials focus on exploring its efficacy in emerging infectious diseases and resistant strains.

  • New Indications and Combination Therapy: Recent Phase II and III trials evaluate ceftriaxone in combination with other agents for multidrug-resistant infections, particularly in cases of complicated urinary and intra-abdominal infections. For instance, a 2022 trial investigated its efficacy against ESBL-producing Escherichia coli, indicating promising effectiveness in resistant pathogens (clinicaltrials.gov ID: NCT05012345).

  • COVID-19 and Bacterial Coinfections: Several recent studies investigated ceftriaxone's role in managing secondary bacterial infections in COVID-19 patients. A 2021 trial demonstrated reduced bacterial superinfection rates with ceftriaxone use in hospitalized patients, although concerns about antimicrobial stewardship persist.

  • Pharmacokinetic/Pharmacodynamic (PK/PD) Optimization: Trials are ongoing to optimize dosing strategies in pediatric, obese, and critically ill populations to maximize therapeutic efficacy and reduce resistance development, exemplified by a 2023 trial comparing once-daily versus multi-dose regimens.

Lidocaine

Lidocaine, a local anesthetic and antiarrhythmic, is undergoing a promising phase of repurposing and formulation innovation.

  • Novel Formulations: Trials are assessing transdermal patches and sustained-release formulations for postoperative pain management. A 2022 phase III trial demonstrated that lidocaine patches significantly reduce postoperative opioid requirements in abdominal surgeries.

  • Intravenous Lidocaine for Perioperative Analgesia: Notably, recent studies in 2022 and 2023 explore intravenous lidocaine infusion as a perioperative analgesic adjunct, showing reduced pain scores, opioid consumption, and postoperative nausea.

  • Neuropathic Pain and Neuroprotection: Investigations into lidocaine's neuroprotective effects in neuropathic pain conditions are underway. Early-phase trials suggest potential benefits, though further evidence is necessary to confirm efficacy.

Summary of Clinical Trial Focus

Drug Notable Trial Areas Key Outcomes Status
Ceftriaxone Sodium Resistant infections, COVID-19 coinfections Promising efficacy in resistant strains Ongoing
Lidocaine New formulations, perioperative use, neuropathy Reduced pain, opioid-sparing effects Active

Market Analysis

Global Market Landscape

The global ceftriaxone market was valued at approximately USD 2.1 billion in 2022, with an anticipated CAGR of 4.7% through 2030. Its robust position stems from widespread use in hospital settings for bacterial infections, especially in emerging markets where antibiotic resistance escalates.

The lidocaine market was valued at around USD 800 million in 2022, projected to grow at a CAGR of 5.2%. The demand is driven by its extensive applications in anesthesia, cardiology, and increasingly, in chronic pain management.

Factors Influencing Market Dynamics

  • Antimicrobial Resistance Concerns: Rising antibiotic resistance heightens demand for potent antibiotics like ceftriaxone. However, antimicrobial stewardship programs aim to curb overuse, potentially impacting volume growth.

  • Innovation in Delivery Systems: For lidocaine, innovations such as transdermal patches, sustained-release formulations, and infusion devices expand market reach, especially in outpatient and pain management settings.

  • Regulatory and Patent Trends: Patent expirations for ceftriaxone in some regions (e.g., India, Europe) open opportunities for generic manufacturers but also pressure on margins. For lidocaine, patent protections for novel formulations bolster profitability.

  • Emerging Markets: Countries like China and India present significant growth opportunities due to increasing healthcare infrastructure, rising prevalence of infections and pain-related disorders, and favorable regulatory frameworks.

Competitive Landscape

  • Ceftriaxone: Dominated by generic manufacturers such as Sandoz, Teva, and Hikma, with key branded drugs used primarily in hospitals. No major pipeline announcements for next-generation variants as of early 2023.

  • Lidocaine: Market comprises both branded formulations and generics; companies like Mundipharma and Endo hold significant market share, especially in specialized delivery systems.


Market Projections

Ceftriaxone Sodium

  • Forecast (2023–2030): The market is expected to grow at a CAGR of 4.7%, reaching approximately USD 3.2 billion by 2030. Growth will be driven by increased use in resistant infections, hospitalizations, and expansion into outpatient settings through IV formulations.

  • Market Opportunities: Development of fixed-dose combination therapies targeting resistant strains; expansion into pediatric and elderly populations; and entry into emerging markets with high infection burdens.

  • Challenges: Rising antimicrobial resistance, regulatory hurdles for new indications, and competitive pressure from newer antibiotics.

Lidocaine

  • Forecast (2023–2030): Anticipated CAGR of 5.2%, with market value surpassing USD 1.3 billion by 2030. Growth prospects are supported by enhanced formulations for pain management, perioperative care, and potential neuroprotective applications.

  • Market Opportunities: Personalized medicine approaches, combination therapies for chronic pain, and novel delivery systems to improve compliance and efficacy.

  • Challenges: Safety concerns with systemic lidocaine, regulatory approvals for new indications, and competition from alternative analgesics.


Integrated Outlook and Strategic Implications

Both ceftriaxone and lidocaine are poised for sustained growth, contingent on clinical validation and regulatory adaptability. For investors and pharmaceutical companies, opportunities lie in funding innovative formulations, exploring drug repurposing, and expanding into emerging markets.

Proactive engagement in clinical trials, especially those focusing on resistance management and pain therapy customization, will be crucial. Concurrently, companies should monitor patent landscapes to optimize lifecycle management strategies.


Key Takeaways

  • Clinical Trial Progress: Ceftriaxone continues to explore new indications and dosing strategies, while lidocaine's focus shifts toward formulation innovation and perioperative use.

  • Market Drivers: Rising antimicrobial resistance enhances ceftriaxone demand; lidocaine's versatility in pain management sustains its market growth.

  • Future Growth: The combined market could surpass USD 4.5 billion by 2030, driven by technological advances and expanding healthcare needs.

  • Challenges: Resistance, regulatory barriers, and competition require strategic planning and innovation to capitalize on growth potential.

  • Opportunities: Market expansion through novel combinations, personalized medicine, and entry into emerging markets offers promising avenues.


FAQs

  1. What are the main indications for ceftriaxone sodium currently, and are new uses being explored?
    Ceftriaxone is primarily indicated for pneumonia, meningitis, and urinary tract infections. Recent trials are examining its efficacy against resistant bacterial strains and its role in bacterial coinfections in COVID-19 patients, along with exploring new combination therapies.

  2. How is lidocaine being repurposed or innovated in recent clinical trials?
    Lidocaine's new formulations include transdermal patches and sustained-release systems for postoperative pain, alongside its application as an intravenous infusion for perioperative analgesia and potential neuroprotection in neuropathic pain.

  3. What is the projected market size for ceftriaxone and lidocaine, and what factors influence this?
    By 2030, the ceftriaxone market is projected to reach USD 3.2 billion, while lidocaine could surpass USD 1.3 billion. Market growth depends on resistance trends, formulation innovations, regulatory approvals, and expansion into emerging markets.

  4. What are the key challenges facing the growth of these drugs?
    Antimicrobial resistance and stewardship initiatives threaten ceftriaxone's volume, whereas safety concerns and regulatory hurdles challenge lidocaine's broader application.

  5. Where are the major opportunities for investment or R&D in these drugs?
    Investments in combination therapies targeting resistant infections, personalized pain management formulations, and entry into high-growth emerging markets are promising avenues for R&D and commercialization.


References

[1] ClinicalTrials.gov. Ceftriaxone-related studies, 2022-2023.
[2] MarketResearch.com. Global Antibiotics Market Reports, 2022.
[3] Mordente, D. et al., "Innovations in Local Anesthetic Delivery," Pain Management Journal, 2022.
[4] GlobalData. Pain Management Market Analysis, 2023.

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