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Comparator: ceftriaxone sodium
Comparator: ceftriaxone sodium is a Third-generation cephalosporin Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Bacterial infections including meningitis, sepsis, and lower respiratory tract infections, Surgical prophylaxis, Gonorrhea and other sexually transmitted infections.
Ceftriaxone sodium is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins.
Ceftriaxone sodium is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. Used for Bacterial infections including meningitis, sepsis, and lower respiratory tract infections, Surgical prophylaxis, Gonorrhea and other sexually transmitted infections.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comparator: ceftriaxone sodium |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Third-generation cephalosporin |
| Target | Penicillin-binding proteins (PBPs) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Ceftriaxone works by disrupting the cross-linking of peptidoglycan in bacterial cell walls, leading to cell wall instability and bacterial death. It has broad-spectrum activity against gram-positive and gram-negative bacteria, with particular efficacy against aerobic organisms. The drug is bactericidal and is commonly used for serious infections including meningitis, sepsis, and surgical prophylaxis.
Approved indications
- Bacterial infections including meningitis, sepsis, and lower respiratory tract infections
- Surgical prophylaxis
- Gonorrhea and other sexually transmitted infections
Common side effects
- Diarrhea
- Rash
- Phlebitis at injection site
- Nausea
- Hypersensitivity reactions
Key clinical trials
- Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
- PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury (PHASE3)
- Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis (NA)
- Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients. (PHASE2)
- CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria (PHASE3)
- Antibiotics for Klebsiella Liver Abscess Study (PHASE4)
- Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055) (PHASE3)
- Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: ceftriaxone sodium CI brief — competitive landscape report
- Comparator: ceftriaxone sodium updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: ceftriaxone sodium
What is Comparator: ceftriaxone sodium?
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Related
- Drug class: All Third-generation cephalosporin drugs
- Target: All drugs targeting Penicillin-binding proteins (PBPs)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial infections including meningitis, sepsis, and lower respiratory tract infections
- Indication: Drugs for Surgical prophylaxis
- Indication: Drugs for Gonorrhea and other sexually transmitted infections
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing