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Also known as CEM-101
solithromycin · 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 ...
Solithromycin is an investigational small-molecule antibiotic being developed by CorMedix Inc. (ticker CRMD) for bacterial infections. It has been studied in community-acquired bacterial pneumonia, uncomplicated urogenital gonorrhea, nonalcoholic steatohepatitis, and general bacterial infection. It is not approved and remains in clinical development.
Solithromycin has been studied for community-acquired bacterial pneumonia, uncomplicated urogenital gonorrhea, nonalcoholic steatohepatitis without cirrhosis, and bacterial infection in adolescents and children. It is an investigational agent and is not approved for any indication. All reported trials of solithromycin have been completed.
Solithromycin is being developed by CorMedix Inc., which trades under the ticker CRMD. CorMedix is the sponsor associated with the clinical development program for solithromycin across its studied indications, including community-acquired bacterial pneumonia and uncomplicated urogenital gonorrhea.
Solithromycin is in Phase 1 development according to its current development status, though individual completed studies have spanned Phase 1 through Phase 3. It is investigational and has not been approved by the FDA. Two trials are listed as completed, with no active trials ongoing.
Completed solithromycin trials include NCT02510599 in nonalcoholic steatohepatitis without cirrhosis, NCT02268279 evaluating pharmacokinetics and safety in adolescents and children, NCT02210325 in uncomplicated urogenital gonorrhea, and NCT01968733 in community-acquired bacterial pneumonia. These studies enrolled a combined total of 1,723 participants across multiple countries.
Yes, solithromycin is also known as CEM-101. The Phase 3 community-acquired bacterial pneumonia trial NCT01968733 refers to the drug as intravenous to oral solithromycin (CEM-101). Both names refer to the same investigational small-molecule antibiotic developed by CorMedix Inc. (ticker CRMD).