Solithromycin

Generic Name: Solithromycin

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₄₃H_₆₅FN_₆O_₁₀

CAS Number: 760981-83-7

Unique Ingredient Identifier: 9U1ETH79CK

Background: Solithromycin is a ketolide antibiotic undergoing clinical development for the treatment of community-acquired pneumonia (CAP) and other infections.

Indication: Investigated for the treatment of community-acquired pneumonia (CAP).

Associated Conditions: -

Associated Therapies: -

Clinical Trials

A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease

Phase 2

Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: Solithromycin

First Posted Date: 2015-12-11

Last Posted Date: 2019-12-30

Lead Sponsor: Imperial College London

Target Recruit Count: 6

Registration Number: NCT02628769

Locations: 🇬🇧
Muscle Lab, Respiratory Medicine, Harefield Hospital, Harefield, Middlesex, United Kingdom

Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

Phase 2

Terminated

Conditions: Community-acquired Bacterial Pneumonia

Interventions: Drug: Solithromycin
Drug: Standard of Care

First Posted Date: 2015-11-16

Last Posted Date: 2019-01-03

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 97

Registration Number: NCT02605122

Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Phase 2

Completed

Conditions: Nonalcoholic Steatohepatitis

Interventions: Drug: solithromycin

First Posted Date: 2015-07-29

Last Posted Date: 2017-03-21

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 10

Registration Number: NCT02510599

Locations: 🇺🇸
Case Western University Hospitals, Cleveland, Ohio, United States

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

Phase 1

Completed

Conditions: Gonorrhoea

Interventions: Drug: Solithromycin

First Posted Date: 2015-01-28

Last Posted Date: 2019-01-28

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 28

Registration Number: NCT02348424

Locations: 🇺🇸
Johns Hopkins Bayview Medical Center - Infectious Diseases, Baltimore, Maryland, United States

Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Phase 1

Completed

Conditions: Bacterial Infection

Interventions: Drug: solithromycin

First Posted Date: 2014-10-20

Last Posted Date: 2017-06-09

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 84

Registration Number: NCT02268279

Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

Phase 3

Completed

Conditions: Uncomplicated Urogenital Gonorrhea

Interventions: Drug: ceftriaxone
Drug: solithromycin
Drug: azithromycin

First Posted Date: 2014-08-06

Last Posted Date: 2017-09-11

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 264

Registration Number: NCT02210325

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

Completed

Conditions: Community-acquired Bacterial Pneumonia

Interventions: Drug: Solithromycin
Drug: Moxifloxacin

First Posted Date: 2013-10-24

Last Posted Date: 2017-03-03

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 863

Registration Number: NCT01968733

Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

Phase 1

Completed

Conditions: Bacterial Infections

Interventions: Drug: Solithromycin

First Posted Date: 2013-10-21

Last Posted Date: 2017-02-23

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 13

Registration Number: NCT01966055

Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Phase 3

Completed

Conditions: Community-acquired Bacterial Pneumonia

Interventions: Drug: Solithromycin
Drug: Moxifloxacin
Other: Placebo to match solithromycin

First Posted Date: 2012-12-25

Last Posted Date: 2017-03-03

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 860

Registration Number: NCT01756339

Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

Phase 2

Completed

Conditions: Uncomplicated Urogenital Gonorrhea

Interventions: Drug: solithromycin
Drug: Solithromycin (CEM-101)

First Posted Date: 2012-05-04

Last Posted Date: 2017-03-03

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 60

Registration Number: NCT01591447

Locations: 🇺🇸
Harborview STD Clinic, Seattle, Washington, United States
🇺🇸
Jefferson County Department of Health, Birmingham, Alabama, United States

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