Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
clarithromycin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| clarithromycin extended release (ER) | DRUG | 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily |
| azithromycin SR | DRUG | Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily |
Inclusion Criteria: Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | - | Undisclosed |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | - | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | N/A | Undisclosed |
Clarithromycin is a small molecule antibiotic used for the treatment of pneumonia in adult patients. It is being developed by Pfizer, Inc. for this infectious disease indication. The drug is currently in Phase 3 clinical development, though the specific trial supporting this stage has been completed.
Clarithromycin is a macrolide antibiotic that works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of susceptible bacteria, blocking peptide bond formation and thereby stopping bacterial growth. This mechanism makes it effective against respiratory pathogens commonly responsible for community-acquired pneumonia.
Clarithromycin is developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on this drug for the treatment of pneumonia in adult patients.
Clarithromycin is in Phase 3 clinical development for the treatment of pneumonia. The Phase 3 trial has been completed, and the drug remains investigational for this indication. It has not been approved by the FDA for pneumonia based on the available clinical data.
Clarithromycin has one completed Phase 3 clinical trial registered as NCT00643227. This multicenter, randomized, double-blind, double-dummy study compared azithromycin SR with clarithromycin extended release for the treatment of pneumonia in 504 adult patients across the United States, Argentina, Canada, Estonia, India, Lithuania, and Russia.
No, clarithromycin and azithromycin are different antibiotics, though both are macrolides. In the Phase 3 trial NCT00643227, clarithromycin extended release was compared against azithromycin SR as an active control. The study was designed to evaluate the efficacy and safety of these two treatments for pneumonia.