Omadacycline

Summary

Omadacycline (CHEMBL1689772) is an approved small molecule (ATC J01AA15); indicated across 6 conditions including bacterial infectious disease and pneumonia.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J01AA15
• Indications: 6 conditions
• Clinical trials: 19
• Chemistry: 556.6 Da · C29H40N4O7

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1689772
Name	Omadacycline
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	54697325
ATC	J01AA15
Molecular formula	C29H40N4O7
Molecular weight	556.6
InChIKey	VJYKVCURWJGLPG-IQZGDKDPSA-N

SMILES: CC(C)(C)CNCC1=CC(=C2C[C@H]3C[C@H]4[C@@H](C(=O)C(=C([C@]4(C(=O)C3=C(C2=C1O)O)O)O)C(=O)N)N(C)C)N(C)C

IUPAC name: (4S,4aS,5aR,12aR)-4,7-bis(dimethylamino)-9-[(2,2-dimethylpropylamino)methyl]-1,10,11,12a-tetrahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide

Also known as: Amadacycline, Omadaciclina, Omadacycline, PTK 0796, OMADACYCLINE, OMADACYCLINE (HYDROCHLORIDE), Omadacycline (hydrochloride), omadacycline

Parent form; salt/anhydrous children: CHEMBL2103854, CHEMBL3942449, CHEMBL3954447

Patent coverage: 328 distinct patent families (698 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 622 (89%) 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: 13 (assay-derived). Sample: 5-hydroxytryptamine receptor 3A, Alpha-2B adrenergic receptor, Muscarinic acetylcholine receptor M2, Muscarinic acetylcholine receptor M1, Prostaglandin G/H synthase 1, Sodium-dependent serotonin transporter, Prostaglandin G/H synthase 2, D(3) dopamine receptor, Delta-type opioid receptor, Adenosine receptor A3.

Bioactivity

ChEMBL activities: 6 potent at pChembl ≥ 5 of 16 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
PTGS1	6.8	AC50	160	nM	CHEMBL_ACT_25206085
PTGS1	6.6	AC50	250	nM	CHEMBL_ACT_25205152
Q63921	6.19	AC50	645	nM	CHEMBL_ACT_25174158
PTGS2	6.07	AC50	844.9	nM	CHEMBL_ACT_25165955
CHRM2	5.37	AC50	4250	nM	CHEMBL_ACT_25195203
CHRM2	5.04	AC50	9200	nM	CHEMBL_ACT_25195664

Target pathways

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

Indications & clinical

Indications

6 indications (1 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
bacterial infectious disease	4	MONDO:0005113	EFO:0000771
pneumonia	3	MONDO:0005249	EFO:0003106
bacterial pneumonia	3	MONDO:0004652	EFO:1001272
urinary tract infection	2	MONDO:0100338	EFO:0003103
cystitis	2	MONDO:0006032	EFO:1000025

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE3	7
PHASE2	5
PHASE1	5
PHASE4	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05515562	PHASE4	COMPLETED	Effects of Intravenous (IV) Omadacycline on Gut Microbiome
NCT06162286	PHASE3	RECRUITING	A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP
NCT00865280	PHASE3	TERMINATED	Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT00876850	PHASE3	WITHDRAWN	Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT02378480	PHASE3	COMPLETED	Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
NCT02531438	PHASE3	COMPLETED	Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
NCT02877927	PHASE3	COMPLETED	Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
NCT04779242	PHASE3	COMPLETED	Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
NCT05753215	PHASE2	ACTIVE_NOT_RECRUITING	Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection
NCT03425396	PHASE2	COMPLETED	Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
NCT03716024	PHASE2	COMPLETED	Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT03757234	PHASE2	COMPLETED	IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
NCT04922554	PHASE2	COMPLETED	Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
NCT04144374	PHASE1	COMPLETED	Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis
NCT04160260	PHASE1	COMPLETED	Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
NCT05217537	PHASE1	COMPLETED	Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
NCT06030219	PHASE1	COMPLETED	Microbiome Effect of Omadacycline on Healthy Volunteers
NCT06462326	PHASE1	COMPLETED	A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
NCT04714411	Not specified	COMPLETED	Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

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