Colistimethate - PharmaKB

Coly-mycin m, Colobreathe(colistimethate)

Colistimethate, Colobreathe, Coly-mycin M (colistimethate) is an unknown pharmaceutical. Colistimethate was first approved as Coly-mycin m on 1982-01-01. It is used to treat bacterial infections, escherichia coli infections, klebsiella infections, pseudomonas infections, and urinary tract infections in the USA. It has been approved in Europe to treat cystic fibrosis.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
respiratory tract diseases	D012140
urogenital diseases	D000091642
hereditary congenital and neonatal diseases and abnormalities	D009358

Trade Name

FDA

EMA

Colistimethate, Coly-mycin m (discontinued: Colistimethate)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Colistimethate sodium

Tradename	Company	Number	Date	Products
COLY-MYCIN M	Endo	N-050108 RX	1982-01-01	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
colistimethate	ANDA	2024-08-29
colistimethate sodium	ANDA	2025-03-12
coly-mycin	New Drug Application	2024-10-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
urinary tract infections	EFO_0003103	D014552	N39.0
bacterial infections	—	D001424	A49
pseudomonas infections	EFO_0001076	D011552	A41.52
escherichia coli infections	EFO_1001318	D004927	B96.20
klebsiella infections	EFO_1001353	D007710	—

Agency Specific

FDA

EMA

No data

Patent Expiration

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ATC Codes

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HCPCS

Code	Description
J0770	Injection, colistimethate sodium, up to 150 mg
S0142	Colistimethate sodium, inhalation solution administered through dme, concentrated form, per mg

Clinical

Clinical Trials

121 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pneumonia	D011014	EFO_0003106	J18	1	6	15	7	13	39
Infections	D007239	EFO_0000544	—	1	3	10	12	11	34
Ventilator-associated pneumonia	D053717	EFO_1001865	J95.851	—	6	12	2	6	22
Communicable diseases	D003141	—	—	—	1	8	8	5	21
Cystic fibrosis	D003550	EFO_0000390	E84	1	1	3	5	3	13
Sepsis	D018805	EFO_0001420	A41.9	1	2	5	4	3	13
Bacteremia	D016470	EFO_0003033	R78.81	1	2	4	2	6	13
Bacterial infections	D001424	—	A49	1	1	2	7	2	12
Fibrosis	D005355	—	—	1	1	2	4	2	10
Critical illness	D016638	—	—	1	1	3	3	1	8

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	1	—	3	—	—	4
Covid-19	D000086382	—	U07.1	—	—	1	—	1	2
Iatrogenic disease	D007049	—	—	—	1	1	—	—	2
Bronchitis	D001991	—	J40	—	—	1	—	1	2
Acute kidney injury	D058186	—	N17	—	—	1	—	1	2
Septic shock	D012772	—	A48.3	—	—	1	—	—	1
Neoplasms	D009369	—	C80	—	1	1	—	—	1
Coinfection	D060085	—	—	—	—	1	—	—	1
Esophageal neoplasms	D004938	—	C15	—	—	1	—	—	1
Mental disorders	D001523	EFO_0000677	F91.9	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pseudomonas infections	D011552	EFO_0001076	A41.52	1	1	—	—	1	3
Pseudomonas aeruginosa	D011550	NCBITaxon_287	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Osteomyelitis	D010019	EFO_0003102	M86	1	—	—	—	—	1
Pneumococcal infections	D011008	EFO_0000772	J13	1	—	—	—	—	1
Disease resistance	D060467	—	—	1	—	—	—	—	1
Gram-negative bacteria	D006090	—	—	1	—	—	—	—	1
Brain diseases	D001927	—	G93.40	1	—	—	—	—	1
Hepatic encephalopathy	D006501	—	K72.91	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Respiratory aspiration	D053120	EFO_1001839	—	—	—	—	—	2	2
Coronavirus infections	D018352	EFO_0007224	B34.2	—	—	—	—	1	1
Virus diseases	D014777	—	B34	—	—	—	—	1	1
Escherichia coli infections	D004927	EFO_1001318	B96.20	—	—	—	—	1	1
Klebsiella pneumoniae	D007711	NCBITaxon_573	B96.1	—	—	—	—	1	1
Neurotoxicity syndromes	D020258	—	G92	—	—	—	—	1	1
Renal insufficiency	D051437	—	N19	—	—	—	—	1	1
Disease	D004194	EFO_0000408	R69	—	—	—	—	1	1
Toxemia	D014115	—	—	—	—	—	—	1	1
Molecular diagnostic techniques	D025202	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Colistimethate
INN	colistimethate sodium
Description	Colistin, also known as polymyxin E, is an antibiotic medication used as a last-resort treatment for multidrug-resistant Gram-negative infections including pneumonia. These may involve bacteria such as Pseudomonas aeruginosa, Klebsiella pneumoniae, or Acinetobacter. It comes in two forms: colistimethate sodium can be injected into a vein, injected into a muscle, or inhaled, and colistin sulfate is mainly applied to the skin or taken by mouth. Colistimethate sodium is a prodrug; it is produced by the reaction of colistin with formaldehyde and sodium bisulfite, which leads to the addition of a sulfomethyl group to the primary amines of colistin. Colistimethate sodium is less toxic than colistin when administered parenterally. In aqueous solutions it undergoes hydrolysis to form a complex mixture of partially sulfomethylated derivatives, as well as colistin. Resistance to colistin began to appear as of 2015.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCC(C)CCCCC(=O)N(CS(=O)(=O)O)[C@@H](CCNCS(=O)(=O)O)C(=O)N[C@@H](CN[C@@H](CCNCS(=O)(=O)O)C(=O)N[C@H]1CCNC(=O)[C@H]([C@@H](C)O)NC(=O)[C@@H](CCNCS(=O)(=O)O)NC(=O)[C@H](CCNCS(=O)(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CCNCS(=O)(=O)O)NC1=O)[C@@H](C)O