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Also known as Solithromycin
CEM-101 · 8 trials · 5 indications
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
| Arm | Type | Description |
|---|---|---|
| Ceftriaxone plus Azithromycin | ACTIVE_COMPARATOR | A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin |
| Solithromycin | EXPERIMENTAL | A single oral dose of 1000 mg solithromycin |
| Moxifloxacin | ACTIVE_COMPARATOR | Intravenous with the potential step-down to oral moxifloxacin |
| Solithromycin (CEM-101) | EXPERIMENTAL | A single oral dose of 1200 mg solithromycin |
| Solithromycin 1000 mg | EXPERIMENTAL | A single oral dose of 1000 mg solithromycin |
| Levofloxacin | ACTIVE_COMPARATOR | - |
| CEM-101 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| solithromycin | DRUG | - |
| ceftriaxone | DRUG | - |
| azithromycin | DRUG | - |
| Moxifloxacin | DRUG | - |
| Placebo to match solithromycin | OTHER | - |
| Solithromycin (CEM-101) | DRUG | A single oral dose of 1000 mg solithromycin |
| Levofloxacin | DRUG | Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5 |
| CEM-101 | DRUG | CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5 |
Inclusion Criteria: * At least 1 of the following: 1. Untreated male with urethral gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration. 2. Untreated female with cervical gonorrhea as determined by ...
CEM-101 is an investigational small molecule being developed for the treatment of Community-Acquired Bacterial Pneumonia (CABP). It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied in patients with this bacterial lung infection.
CEM-101 is a small molecule antibiotic, but its specific molecular target has not been disclosed in the available information. It is being studied for its efficacy and safety in treating Community-Acquired Bacterial Pneumonia, indicating it acts against the bacteria responsible for this infection.
CEM-101 is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Community-Acquired Bacterial Pneumonia.
CEM-101 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 clinical trial has been completed to assess its efficacy and safety compared to levofloxacin in patients with Community-Acquired Bacterial Pneumonia.
CEM-101 has one completed Phase 2 clinical trial, identified as NCT01168713. This randomized, double-blind, active-controlled study compared oral CEM-101 to oral levofloxacin in 132 patients with Community-Acquired Bacterial Pneumonia. The trial was conducted in the United States and Canada.
CEM-101 is also known by the name solithromycin, though this alternative name is not provided in the available data. The drug is being developed by CorMedix Inc. under the designation CEM-101 for the treatment of Community-Acquired Bacterial Pneumonia.