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CEM-101
CEM-101 is a potent and selective inhibitor of the histone deacetylase 6 (HDAC6) enzyme.
CEM-101 is a potent and selective inhibitor of the histone deacetylase 6 (HDAC6) enzyme. Used for Relapsed or refractory multiple myeloma.
At a glance
| Generic name | CEM-101 |
|---|---|
| Also known as | Solithromycin |
| Sponsor | Melinta Therapeutics, Inc. |
| Drug class | HDAC inhibitor |
| Target | HDAC6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
By inhibiting HDAC6, CEM-101 disrupts the interaction between HDAC6 and microtubules, leading to the accumulation of acetylated microtubules and the induction of apoptosis in cancer cells. This mechanism of action is thought to contribute to the antitumor activity of CEM-101.
Approved indications
- Relapsed or refractory multiple myeloma
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease (PHASE2)
- Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin (PHASE1)
- Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia (PHASE2, PHASE3)
- Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea (PHASE3)
- Pharmacokinetics and Safety of Solithromycin in Adolescents and Children (PHASE1)
- Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis (PHASE2)
- Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia (PHASE3)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CEM-101 CI brief — competitive landscape report
- CEM-101 updates RSS · CI watch RSS
- Melinta Therapeutics, Inc. portfolio CI