Solithromycin Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 development have evaluated solithromycin across infectious and inflammatory conditions, including community-acquired bacterial pneumonia, uncomplicated urogenital gonorrhea, pediatric bacterial infections, chronic obstructive pulmonary disease, and nonalcoholic steatohepatitis. Sponsored by pharmaceutical companies, academic institutions, and government agencies, key late-phase studies investigating antimicrobial efficacy and pharmacokinetics have reached completed status. Conversely, certain trials evaluating anti-inflammatory indications were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02605122	TERMINATED	Community-acquired Bacterial Pneumonia	Melinta Therapeutics, Inc.	2016-04	PHASE2; PHASE3
NCT02210325	COMPLETED	Uncomplicated Urogenital Gonorrhea	Melinta Therapeutics, Inc.	2014-08	PHASE3
NCT02510599	COMPLETED	Nonalcoholic Steatohepatitis	Melinta Therapeutics, Inc.	2015-12	PHASE2
NCT02348424	COMPLETED	Gonorrhoea	National Institute of Allergy and Infectious Diseases (NIAID)	2015-05-05	PHASE1
NCT02628769	TERMINATED	Pulmonary Disease, Chronic Obstructive	Imperial College London	2015-07	PHASE2
NCT02268279	COMPLETED	Bacterial Infection	Melinta Therapeutics, Inc.	2015-01	PHASE1
NCT02628769	Terminated	Pulmonary Disease Chronic Obstructive	Imperial College London\|Melinta Therapeutics Inc.	2015-07	Phase 2
NCT01968733	COMPLETED	Community-acquired Bacterial Pneumonia	Melinta Therapeutics, Inc.	2013-11	PHASE3
NCT02348424	Completed	Gonorrhoea	National Institute of Allergy and Infectious Diseases (NIAID)	2015-05-05	Phase 1
NCT02268279	Completed	Bacterial Infection	Melinta Therapeutics Inc.\|Department of Health and Human Services	2015-01	Phase 1
NCT01756339	COMPLETED	Community-acquired Bacterial Pneumonia	Melinta Therapeutics, Inc.	2012-12	PHASE3
NCT02210325	Completed	Uncomplicated Urogenital Gonorrhea	Melinta Therapeutics Inc.\|National Institute of Allergy and Infectious Diseases (NIAID)	2014-08	Phase 3
NCT01966055	COMPLETED	Bacterial Infections	Melinta Therapeutics, Inc.	2013-12	PHASE1
NCT01966055	Completed	Bacterial Infections	Melinta Therapeutics Inc.\|Department of Health and Human Services	2013-12	Phase 1
NCT01591447	COMPLETED	Uncomplicated Urogenital Gonorrhea	Melinta Therapeutics, Inc.	2012-05	PHASE2
NCT01591447	Completed	Uncomplicated Urogenital Gonorrhea	Melinta Therapeutics Inc.	2012-05	Phase 2

(data from https://clinicaltrials.gov, updated on 2019-01-03)

Check the Solithromycin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Solithromycin, a fluoroketolide macrolide antibiotic, binds with high affinity to multiple sites on the bacterial 50S ribosomal subunit, thereby blocking nascent peptide chain elongation and suppressing protein synthesis. By halting essential translation in susceptible pathogens, the compound exhibits potent bactericidal activity, providing a biological rationale for its clinical evaluation in bacterial infections such as community-acquired bacterial pneumonia and gonorrhea.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).