CLINICAL TRIALS PROFILE FOR CEFTRIAXONE SODIUM

505(b)(2) Clinical Trials for CEFTRIAXONE SODIUM

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	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

All Clinical Trials for CEFTRIAXONE SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	Hoffmann-La Roche	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00002052 ↗	Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients	Completed	University of Southern California	N/A	1969-12-31	To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.
NCT00004216 ↗	VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Therapy	Completed	Vion Pharmaceuticals	Phase 1	1999-08-01	RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy.

Clinical Trial Conditions for CEFTRIAXONE SODIUM

Condition Name

Condition Name for CEFTRIAXONE SODIUM
Intervention	Trials
Surgical Site Infection	3
Diverticulitis	2
Appendicitis	2
HIV Infections	2

Condition MeSH

Condition MeSH for CEFTRIAXONE SODIUM
Intervention	Trials
Infections	10
Infection	9
Communicable Diseases	9
Intraabdominal Infections	3

Clinical Trial Locations for CEFTRIAXONE SODIUM

Trials by Country

Trials by Country for CEFTRIAXONE SODIUM
Location	Trials
United States	47
Japan	15
Australia	6
Canada	4
Brazil	3

Trials by US State

Trials by US State for CEFTRIAXONE SODIUM
Location	Trials
Massachusetts	3
Connecticut	3
California	3
Texas	3
Ohio	3

Clinical Trial Progress for CEFTRIAXONE SODIUM

Clinical Trial Phase

Clinical Trial Phase for CEFTRIAXONE SODIUM
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for CEFTRIAXONE SODIUM
Clinical Trial Phase	Trials
Completed	16
Not yet recruiting	3
Recruiting	3

Clinical Trial Sponsors for CEFTRIAXONE SODIUM

Sponsor Name

Sponsor Name for CEFTRIAXONE SODIUM
Sponsor	Trials
Merck Sharp & Dohme Corp.	2
Wyeth is now a wholly owned subsidiary of Pfizer	2
International Centre for Diarrhoeal Disease Research, Bangladesh	2

Sponsor Type

Sponsor Type for CEFTRIAXONE SODIUM
Sponsor	Trials
Other	21
Industry	11
NIH	1

Ceftriaxone Sodium: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is ceftriaxone sodium’s clinical development status?

Ceftriaxone sodium is an established, off-patent third-generation cephalosporin administered for a wide range of bacterial infections. In markets where ceftriaxone is widely available, the late-stage development pipeline is dominated by (1) generics and authorized-label extensions, (2) formulation work (stability, dosing convenience, bolus/infusion compatibility), and (3) periodic clinical revalidation in specific indications or populations rather than first-in-class innovation. For business planning, the practical signal is not a single pivotal Phase 3 program but a continuous stream of incremental studies tied to labeling, dosing regimens, and comparators.

Trial activity pattern (what to expect in ceftriaxone)

• Trial types: Phase 3/4 comparative effectiveness in bacterial infections; Phase 1/2 PK/PD or bioequivalence for generic products; safety/tolerability studies in special populations (pediatrics, renal/hepatic impairment).
• Geographic distribution: High-volume studies occur in markets with large generic penetration and high burden of bacterial disease; EU/US programs trend toward label updates, PK/BE, and stewardship-aligned regimens.
• Competitive comparator structure: Most comparative studies use ceftriaxone against other beta-lactams (e.g., cephalosporins) or broad-spectrum agents, with endpoints built around microbiologic eradication, clinical cure, and safety.

Evidence base location (public records) Ceftriaxone trials are consistently indexed in major registries under ceftriaxone/ceftriaxone sodium and brand or manufacturer-specific generic names. The most decision-useful view for investors is not “did it have trials,” but “what trials support new labeling, new formulations, or new dosing regimens.” Those are the trials that move volume after approval.

Which trials matter for commercialization and labeling?

Across established antibiotics, the trials that matter commercially fall into four buckets:

1) Bioequivalence and formulation bridging

• Targets: approval of generics, new strengths, new manufacturing sites, improved stability formats, and reconstitution volume/compatibility data.
• Commercial impact: directly reduces cost per dose and increases tender wins in hospital procurement.

2) Special population evidence

• Targets: neonates, pediatrics, renal impairment, hepatic impairment.
• Commercial impact: supports broader label coverage and reduces risk friction for clinicians.

3) Indication revalidation

• Targets: community-acquired infections, hospital-acquired infections, specific organism-focused indications, and syndromic bundles.
• Commercial impact: preserves or expands prescribing share where formularies still list ceftriaxone.

4) Stewardship and regimen studies

• Targets: dosing optimization (once-daily vs frequency adjustments), duration strategies, and de-escalation pathways.
• Commercial impact: can stabilize volumes even when overall antibiotic consumption changes.

Decision metric For ceftriaxone, the “market-moving” element is typically tender price and availability, not brand-specific clinical superiority. Trials influence volume mainly through inclusion in formulary and through label fit for specific care pathways.

What is the market size and commercial structure?

Ceftriaxone sits in the global hospital antibiotic backbone category, with volume driven by:

• Broad-spectrum clinical use across common serious bacterial infections
• Entrenchment in hospital protocols and emergency treatment pathways
• Massive generic supply chains and price competition

Market structure

• Supply: predominantly generic manufacturers plus limited originator presence depending on territory and product type (e.g., strengths, packaging formats).
• Distribution: strong hospital procurement and direct tender cycles.
• Pricing: compressed by generics, with periodic shifts tied to API cost cycles and manufacturing outages.

Competitive implications Because ceftriaxone is commoditized, a product’s commercial outcome is determined by:

• Cost per dose at tender,
• Supply reliability and inspection outcomes,
• Label alignment with local guidelines,
• Packaging and administration convenience (single-dose vials, reconstitution practicality),
• Stability and logistics (shelf-life, transport conditions).

How does generic competition shape pricing and volume?

Generic penetration typically reduces unit margins and shifts competition from clinical differentiation to operational excellence.

Pricing dynamics

• High buyer power: hospital systems and national procurement bodies negotiate aggressively.
• Tender frequency: frequent cycles reward lowest total acquisition cost and reliable supply.
• Substitution pressure: when formularies allow, clinicians default to the least expensive equivalent.
• Risk premiums: any supply disruption drives short-term price spikes, followed by normalization.

What wins tenders

• Consistent API access and scalable packaging lines
• Documentation quality (regulatory dossiers, batch consistency)
• Fast delivery and low stockout risk

What is the projection for ceftriaxone demand (2025-2035)?

For off-patent antibiotics, demand projection is driven by epidemiology and access rather than new product launches. Ceftriaxone demand typically tracks:

• Hospital admissions for bacterial infections
• Antimicrobial stewardship policies
• Resistance trends that affect clinician preferences (not eliminating ceftriaxone, but potentially shifting use toward or away from it by guideline updates)
• Public procurement and reimbursement structures

Base-case demand outlook

• Stable-to-moderate growth by volume: Ceftriaxone remains a frequently used injectable for serious bacterial infections.
• Flat-to-declining revenue by unit pricing: Generics keep price growth constrained.
• Revenue resilience through volume and territory expansion: Strong uptake persists where healthcare access is increasing or where ceftriaxone remains guideline-supported.

Key projection drivers (business-relevant)

• Guideline durability: If local treatment standards continue to list ceftriaxone as a first-line option for selected infections, volumes stay resilient.
• Resistance management: Escalation to alternatives can reduce ceftriaxone share in high-resistance settings, but does not typically remove use entirely.
• Supply shocks: Manufacturing interruptions can temporarily lift prices and market share for surviving suppliers.
• Stewardship: Use may be restricted by duration or criteria, but ceftriaxone retains a role in initial empiric therapy.

What is the commercial forecast by value chain position?

A practical way to forecast ceftriaxone is by who captures value:

1) API and intermediate producers

• Value depends on API cost cycles, capacity, compliance, and contracted supply.
• Margin volatility is higher than in finished-dose packaged goods.

2) Finished-dose generic manufacturers

• Revenue tracks tender wins and distribution reach.
• Margin is sensitive to raw material pricing, logistics costs, and regulatory inspection outcomes.

3) Distributors and procurement aggregators

• Lower value capture per unit, but benefit from scale and contract leverage.

4) Authorized channel brand holders (where applicable)

• Capture limited premium over generics if they have supply leadership or regulatory advantages in certain territories.

How does regulation affect market entry and pricing?

Ceftriaxone is generally subject to standard antibiotic manufacturing and quality frameworks:

• Good Manufacturing Practice (GMP) requirements
• Batch testing and stability protocols
• Pharmacovigilance obligations

Market entry reality For ceftriaxone, the barrier is less about patent and more about:

• Ability to produce consistent API quality
• Finished-dose bioequivalence/formulation evidence requirements by jurisdiction
• Timely regulatory approval and dossier acceptance
• Ability to supply in tender timelines

This environment favors established manufacturers with mature QA/QC systems.

What are the likely risk factors that change projections?

1) Regulatory or quality events

• GMP sanctions or recall events can remove supply capacity quickly.

2) Resistance-driven guideline shifts

• If local resistance patterns or treatment algorithms reduce ceftriaxone empiric use for key infections, share declines.

3) Pricing compression

• Continued generics and tender liberalization can pressure revenue growth.

4) API supply constraints

• Interruptions can temporarily raise prices, but can also lead buyers to shift to alternates if shortages persist.

Key takeaways

• Ceftriaxone sodium is a mature, commoditized antibiotic with commercialization driven primarily by generics, tender pricing, and supply reliability rather than new clinical differentiation.
• Clinical trial activity in major registries is typically centered on formulation bridging, bioequivalence, and label-aligned studies in special populations or revalidated indications.
• Market value is constrained by generic pricing pressure, while volume demand stays supported by persistent hospital use in serious bacterial infections.
• Forecasts for 2025-2035 are most consistent with stable-to-moderate volume growth and flat-to-declining unit revenue, with volatility driven by supply disruptions, resistance-guideline shifts, and procurement cycles.

FAQs

1) Does ceftriaxone sodium have active late-stage trials that could reshape the market?
Most trial activity is incremental (bioequivalence, formulation, special population and label support), which typically does not reset the market the way a new molecular entity would.

2) What clinical outcomes do ceftriaxone trials usually target?
Common endpoints include clinical cure and microbiologic eradication, with safety and tolerability as core secondary outcomes.

3) What drives ceftriaxone tender wins most consistently?
Lowest total acquisition cost with reliable supply, compliant manufacturing, and label fit with local treatment pathways.

4) How do antimicrobial resistance trends affect ceftriaxone share?
Resistance and guideline updates can shift empiric and targeted therapy away from ceftriaxone in high-resistance settings, reducing share even if overall antibiotic use remains high.

5) What type of company is best positioned to capture value in ceftriaxone?
Manufacturers with stable API access, strong GMP performance, and mature procurement execution capture the most reliable revenue in a commoditized market.

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] WHO. (2019). WHO Model List of Essential Medicines (EML). World Health Organization. https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/access-to-medicines/essential-medicines
[3] European Medicines Agency. (n.d.). EMA medicines. https://www.ema.europa.eu/en/medicines
[4] FDA. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[5] CDC. (n.d.). Antibiotic use and stewardship information. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/