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Solithromycin · 7 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)
| 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 |
| 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 |
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 being studied for bacterial infections, including community-acquired bacterial pneumonia and uncomplicated urogenital gonorrhea, as well as nonalcoholic steatohepatitis. It is developed by CorMedix Inc. and is currently in clinical development, though no active trials are ongoing.
Solithromycin is a macrolide antibiotic that targets the bacterial ribosome to inhibit protein synthesis. It is being studied for its antibacterial activity against pathogens causing community-acquired bacterial pneumonia and other bacterial infections. The drug is also being investigated for nonalcoholic steatohepatitis, though its mechanism in that condition is not specified.
Solithromycin is developed by CorMedix Inc., a biopharmaceutical company traded under the ticker CRMD. The drug is an investigational small molecule in the infectious disease therapeutic area, with completed clinical trials in bacterial infections and nonalcoholic steatohepatitis.
Solithromycin is in Phase 1 clinical development, based on the most recent trial listed. It has completed Phase 1, Phase 2, and Phase 3 trials, but it is not approved and remains investigational. The drug is not currently in any active clinical trials.
Solithromycin has completed four clinical trials, including NCT01756339, a Phase 3 study in community-acquired bacterial pneumonia with 860 participants, and NCT01966055 and NCT02268279, Phase 1 studies in bacterial infections. NCT02510599 was a Phase 2 trial in nonalcoholic steatohepatitis. All trials are completed.
Yes, Solithromycin is also known as CEM-101, as referenced in the clinical trial title for NCT01756339. This alternative name is used in research contexts, and readers searching for CEM-101 will find information about Solithromycin, the same investigational drug developed by CorMedix Inc.