Synonyms: CEM-101 | CEM101 | compound 3 [PMID: 30258539] | OP-1068 | OP1068 | Solithera | T-4288 | T4288
Compound class:
Synthetic organic
Comment: Solithromycin is a next-generation oral and intravenous fluoroketolide (macrolide) antibacterial that has activity against Gram-positive and Gram-negative bacteria [2].
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No information available. |
Summary of Clinical Use |
Phase 3 trials evaluating solithromycin in uncomplicated urogenital gonorrhea [3] and community-acquired bacterial pneumonia (CABP) have been completed [1,4,6]. |
Clinical Trials | |||||
Clinical Trial ID | Title | Type | Source | Comment | References |
NCT01756339 | Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia | Phase 3 Interventional | Melinta Therapeutics, Inc. | 1 | |
NCT02210325 | Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea | Phase 3 Interventional | Melinta Therapeutics, Inc. | Results indicate that solithromycin (single 1000 mg dose) is not a suitable alternative to ceftriaxone plus azithromycin as a first-line treatment for gonorrhoea. | 3 |
NCT01968733 | Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia | Phase 3 Interventional | Melinta Therapeutics, Inc. | This study concluded that solithromycin has potential as an intravenous and oral monotherapy for CABP. | 4 |