Solithromycin

Summary

Solithromycin (CHEMBL1232510) is a phase-3 clinical-stage small molecule (ATC J01FA16); indicated across 5 conditions including gonorrhea and bacterial infectious disease.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• ATC class: J01FA16
• Indications: 5 conditions
• Clinical trials: 11
• Chemistry: 845 Da · C43H65FN6O10

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1232510
Name	Solithromycin
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	25242512
ATC	J01FA16
Molecular formula	C43H65FN6O10
Molecular weight	845
InChIKey	IXXFZUPTQVDPPK-ZAWHAJPISA-N

SMILES: CC[C@@H]1[C@@]2([C@@H]([C@H](C(=O)[C@@H](C[C@@]([C@@H]([C@H](C(=O)[C@](C(=O)O1)(C)F)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)C)O)(C)OC)C)C)N(C(=O)O2)CCCCN4C=C(N=N4)C5=CC(=CC=C5)N)C

IUPAC name: (1S,2R,5S,7R,8R,9R,11R,13R,14R)-15-[4-[4-(3-aminophenyl)triazol-1-yl]butyl]-8-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-5-fluoro-9-methoxy-1,5,7,9,11,13-hexamethyl-3,17-dioxa-15-azabicyclo[12.3.0]heptadecane-4,6,12,16-tetrone

Also known as: CEM 101, CEM-101, CEM101, OP 1068, OP-1068, OP1068, Solithromycin, Solithromycine, Solitromicina, SOLITHROMYCIN, solithromycin

Patent coverage: 333 distinct patent families (912 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 888 (97%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Bacterial 70S ribosome.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
P02358	9.22	Kd	0.6	nM	CHEMBL_ACT_19058248
P02358	7.22	Ki	60.3	nM	CHEMBL_ACT_22489759

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

5 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
gonorrhea	3	MONDO:0004277	DOID:7551
bacterial infectious disease	3	MONDO:0005113	EFO:0000771
bacterial pneumonia	3	MONDO:0004652	EFO:1001272
chronic obstructive pulmonary disease	2	MONDO:0005002	EFO:0000341
metabolic dysfunction-associated steatohepatitis	2	MONDO:0007027	EFO:1001249

Clinical trials

Total trials: 11.

Phase distribution

Phase	Trials
PHASE2	4
PHASE3	3
PHASE1	3
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01756339	PHASE3	COMPLETED	Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
NCT01968733	PHASE3	COMPLETED	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
NCT02210325	PHASE3	COMPLETED	Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
NCT02605122	PHASE2/PHASE3	TERMINATED	Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
NCT01168713	PHASE2	COMPLETED	Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
NCT01591447	PHASE2	COMPLETED	Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
NCT02510599	PHASE2	COMPLETED	Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
NCT02628769	PHASE2	TERMINATED	A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease
NCT01966055	PHASE1	COMPLETED	Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
NCT02268279	PHASE1	COMPLETED	Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
NCT02348424	PHASE1	COMPLETED	Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).