Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 antibiotic being studied for bacterial infections, including community-acquired bacterial pneumonia, uncomplicated urogenital gonorrhea, and nonalcoholic steatohepatitis. It is in clinical development by CorMedix Inc. and has not been approved by the FDA.
CorMedix Inc. (ticker: CRMD) is developing Solithromycin. The drug is an investigational small molecule antibiotic in clinical trials for bacterial infections and other conditions.
Solithromycin is in Phase 1 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials, but it remains investigational and is not FDA approved.
Solithromycin has been studied in several completed trials, including NCT01756339, a Phase 3 trial in community-acquired bacterial pneumonia with 860 participants, and NCT01966055, a Phase 1 trial in adolescents with bacterial infections. Other trials include NCT02268279 and NCT02510599.
Yes, Solithromycin is also known as CEM-101. The Phase 3 trial NCT01756339 refers to oral Solithromycin (CEM-101) compared to moxifloxacin in patients with community-acquired bacterial pneumonia.