Hydroxocobalamin - PharmaKB

Cyanokit(hydroxocobalamin)

Cyanokit, Hydroxocobalamin (hydroxocobalamin) is a small molecule pharmaceutical. Hydroxocobalamin was first approved as Hydroxocobalamin on 1982-01-01. It is used to treat alcoholic neuropathy, diabetic neuropathies, multiple sclerosis, pernicious anemia, and poisoning in the USA. It has been approved in Europe to treat poisoning.

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Events

FDA approval date

EMA approval date

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Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
hemic and lymphatic diseases	D006425
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700
immune system diseases	D007154
chemically-induced disorders	D064419

Trade Name

FDA

EMA

Cyanokit, Hydroxocobalamin (discontinued: Alpharedisol, Cyanokit, Hydroxocobalamin, Hydroxomin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Hydroxocobalamin

Tradename	Company	Number	Date	Products
CYANOKIT	BTG	N-022041 RX	2011-04-08	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
aronamin gold	unapproved drug other	2018-12-12
cyanokit	New Drug Application	2023-04-27
hydroxocobalamin	unapproved drug other	2026-05-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
multiple sclerosis	EFO_0003885	D009103	G35
diabetic neuropathies	EFO_1000783	D003929	—
alcoholic neuropathy	EFO_1000803	D020269	G62.1
poisoning	EFO_0008546	D011041	T65.91
pernicious anemia	EFO_0005576	D000752	D51.0

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

B: Blood and blood forming organ drugs

— B03: Antianemic preparations

— B03B: Vitamin b12 and folic acid

— B03BA: Vitamin b12 (cyanocobalamin and analogues)

— B03BA03: Hydroxocobalamin

— B03BA53: Hydroxocobalamin, combinations

V: Various drug classes in atc

— V03: All other therapeutic products

— V03A: All other therapeutic products

— V03AB: Antidotes

— V03AB33: Hydroxocobalamin

HCPCS

No data

Clinical

Clinical Trials

755 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vitamin b 12 deficiency	D014806	EFO_0000734	E53.8	2	4	2	5	49	60
Anemia	D000740	EFO_0004272	D64.9	—	4	8	6	36	52
Diabetic neuropathies	D003929	EFO_1000783	—	1	3	2	2	10	17
Cognitive dysfunction	D060825	—	G31.84	1	4	—	1	11	17
Iron deficiencies	D000090463	—	E61.1	—	1	2	2	13	17
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	2	2	2	10	16
Inflammation	D007249	MP_0001845	—	1	—	—	1	14	16
Hyperhomocysteinemia	D020138	—	—	—	1	2	1	12	16
Healthy volunteers/patients	—	—	—	2	2	—	1	11	16
Iron-deficiency anemia	D018798	—	D50	—	—	1	3	12	16

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-small-cell lung carcinoma	D002289	—	—	1	17	9	—	4	29
Malnutrition	D044342	EFO_0008572	E40-E46	—	2	3	—	17	21
Avitaminosis	D001361	EFO_0005878	E56.9	—	2	4	—	12	16
Covid-19	D000086382	—	U07.1	1	2	3	—	8	13
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	3	1	—	10	13
Depression	D003863	—	F33.9	—	2	1	—	9	11
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	2	—	8	11
Lung neoplasms	D008175	—	C34.90	1	9	2	—	—	10
Parkinson disease	D010300	EFO_0002508	G20	—	1	1	—	9	10
Peripheral nervous system diseases	D010523	—	G64	1	3	1	—	4	8

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Recurrence	D012008	—	—	6	5	—	—	—	9
Brain injuries	D001930	—	S06.9	2	1	—	—	3	5
Micronutrients	D018977	—	—	—	1	—	—	4	5
Fibromyalgia	D005356	EFO_0005687	M79.1	2	1	—	—	3	5
Systemic lupus erythematosus	D008180	EFO_0002690	M32	—	1	—	—	3	4
Affect	D000339	—	—	—	1	—	—	3	4
Memory disorders	D008569	—	—	—	1	—	—	3	4
Coronavirus infections	D018352	EFO_0007224	B34.2	1	1	—	—	2	3
Sars-cov-2	D000086402	—	—	2	2	—	—	1	3
Thyroid diseases	D013959	—	E00-E07	—	1	—	—	2	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	1	—	—	—	4	5
Weight loss	D015431	—	—	1	—	—	—	4	5
Heart failure	D006333	EFO_0003144	I50	1	—	—	—	3	4
Colorectal neoplasms	D015179	—	—	1	—	—	—	2	3
Child development	D002657	—	—	1	—	—	—	2	3
Sezary syndrome	D012751	—	C84.1	2	—	—	—	—	2
Mycosis fungoides	D009182	—	C84.0	2	—	—	—	—	2
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
Multiple sclerosis	D009103	EFO_0003885	G35	1	—	—	—	1	2
Cognition disorders	D003072	—	—	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Folic acid deficiency	D005494	EFO_0001070	E53.8	—	—	—	—	12	12
Deglutition disorders	D003680	—	R13.1	—	—	—	—	9	9
Gastroesophageal reflux	D005764	EFO_0003948	K21	—	—	—	—	7	7
Gyrate atrophy	D015799	—	—	—	—	—	—	6	6
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	—	—	—	6	6
Vitamin a deficiency	D014802	EFO_1001237	E50	—	—	—	—	6	6
Fatigue	D005221	—	R53.83	—	—	—	—	5	5
Infections	D007239	EFO_0000544	—	—	—	—	—	4	4
Nutritional status	D009752	—	—	—	—	—	—	4	4
Metabolic diseases	D008659	EFO_0000589	E88.9	—	—	—	—	4	4

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Hydroxocobalamin
INN	hydroxocobalamin
Description	Hydroxocobalamin, also known as vitamin B12a and hydroxycobalamin, is a vitamin found in food and used as a dietary supplement. As a supplement it is used to treat vitamin B12 deficiency including pernicious anemia. Other uses include treatment for cyanide poisoning, Leber's optic atrophy, and toxic amblyopia. It is given by injection into a muscle or vein.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—