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Ceftriaxone/ Clarithromycin
Ceftriaxone/ Clarithromycin is a Combination antibiotic (cephalosporin + macrolide) Small molecule drug developed by RAAS Nutritionals, LLC. It is currently in Phase 3 development for Community-acquired pneumonia, Respiratory tract infections, Other bacterial infections responsive to combination therapy.
This combination uses a third-generation cephalosporin antibiotic and a macrolide antibiotic to inhibit bacterial cell wall synthesis and protein synthesis, respectively, providing broad-spectrum antimicrobial coverage.
Ceftriaxone is a small molecule inhibitor of bacterial penicillin-binding protein, classified as an INHIBITOR. It is used to treat conditions such as osteomyelitis, community-acquired pneumonia, and sepsis, and can be administered orally or intravenously.
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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.
| 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 | Ceftriaxone/ Clarithromycin |
|---|---|
| Sponsor | RAAS Nutritionals, LLC |
| Drug class | Combination antibiotic (cephalosporin + macrolide) |
| Target | Bacterial cell wall (penicillin-binding proteins) and bacterial 50S ribosome |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Ceftriaxone inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins and blocking peptidoglycan cross-linking. Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. Together, they provide synergistic coverage against a wide range of gram-positive and gram-negative bacteria, as well as atypical organisms.
Approved indications
- Community-acquired pneumonia
- Respiratory tract infections
- Other bacterial infections responsive to combination therapy
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Headache
- Rash
- Hypersensitivity reactions
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT) (PHASE4)
- Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) (PHASE3)
- Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes (NA)
- A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor (PHASE3)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia (PHASE3)
- Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients (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:
- Ceftriaxone/ Clarithromycin CI brief — competitive landscape report
- Ceftriaxone/ Clarithromycin updates RSS · CI watch RSS
- RAAS Nutritionals, LLC portfolio CI
Frequently asked questions about Ceftriaxone/ Clarithromycin
What is Ceftriaxone/ Clarithromycin?
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What does Ceftriaxone/ Clarithromycin target?
Related
- Drug class: All Combination antibiotic (cephalosporin + macrolide) drugs
- Target: All drugs targeting Bacterial cell wall (penicillin-binding proteins) and bacterial 50S ribosome
- Manufacturer: RAAS Nutritionals, LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Respiratory tract infections
- Indication: Drugs for Other bacterial infections responsive to combination therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing