Naltrexone - PharmaKB

Revia, Mysimba(naltrexone)

Contrave, Embeda, Mysimba, Naltrexone, Troxyca, Vivitrol (naltrexone) is a small molecule pharmaceutical. Naltrexone was first approved as Revia on 1984-11-20. It is used to treat alcoholism, drug overdose, and opioid-related disorders in the USA. It has been approved in Europe to treat obesity and overweight. The pharmaceutical is active against mu-type opioid receptor, delta-type opioid receptor, and kappa-type opioid receptor.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750
signs and symptoms pathological conditions	D013568
chemically-induced disorders	D064419
diagnosis	D003933
mental disorders	D001523
physiological phenomena	D010829

Trade Name

FDA

EMA

Naltrexone, Vivitrol (discontinued: Naltrexone, Revia)

Combinations

Contrave (discontinued: Embeda, Troxyca)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Morphine sulfate

Naltrexone hydrochloride

Tradename	Company	Number	Date	Products
EMBEDA	Alpharma	N-022321 DISCN	2009-08-13	6 products, RLD

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Naltrexone hydrochloride

Oxycodone hydrochloride

Tradename	Company	Number	Date	Products
TROXYCA ER	Pfizer	N-207621 DISCN	2016-08-19	6 products

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Naltrexone

Tradename	Company	Number	Date	Products
VIVITROL	Alkermes	N-021897 RX	2006-04-13	1 products, RLD, RS

Bupropion hydrochloride

Naltrexone hydrochloride

Tradename	Company	Number	Date	Products
CONTRAVE	Nalpropion Pharmaceuticals	N-200063 RX	2014-09-10	1 products, RLD, RS

Naltrexone hydrochloride

Tradename	Company	Number	Date	Products
REVIA	Teva	N-018932 DISCN	1984-11-20	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
contrave	New Drug Application	2025-05-07
naltrexone	unapproved drug other	2018-03-19
naltrexone hydrochloride	ANDA	2025-05-21
naltrexone hyrdochloride	ANDA	2009-07-21
trexall	ANDA	2021-04-30
vivitrol	New Drug Application	2024-05-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
alcoholism	EFO_0003829	D000437	F10.1
opioid-related disorders	EFO_0005611	D009293	F11
dyspnea	—	D004417	R06.0
drug overdose	—	D062787	—
intractable pain	—	D010148	—
postoperative pain	—	D010149	G89.18
tobacco use disorder	—	D014029	F17
attention deficit disorder with hyperactivity	EFO_0003888	D001289	F90
depressive disorder	EFO_1002014	D003866	F32.A

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Bupropion Hydrochloride / Naltrexone Hydrochloride, Contrave, Nalpropion
10231964	2034-07-02		U-1583
10828294	2034-07-02		U-1583
10835527	2034-07-02		U-1583
9633575	2033-06-25		U-1583
10403170	2033-06-05		U-1583
11139056	2033-06-05		U-1583
9248123	2032-01-13		U-1808
11033543	2031-01-10		U-1583
8916195	2030-02-02		U-1639
11324741	2029-05-29		U-1583
8088786	2029-02-03	DP
8318788	2027-11-08		U-1584
8722085	2027-11-08		U-1585
9125868	2027-11-08		U-1585
10307376	2027-11-08		U-1585
9107837	2027-06-04		U-1639
7375111	2025-03-26	DP
7462626	2024-07-20		U-1583
8815889	2024-07-20		U-1586
11278544	2024-04-21		U-1583
Morphine Sulfate / Naltrexone Hydrochloride, Embeda, Alpharma Pharms
8623418	2029-11-07		U-1640
7815934	2027-12-12	DP
7682633	2027-06-19		U-1510
7682634	2027-06-19	DP
8158156	2027-06-19		U-1510
8846104	2027-06-19	DP
8877247	2027-06-19	DP
8685443	2025-07-03		U-1508
8685444	2025-07-03	DP
Naltrexone, Vivitrol, Alkermes
7919499	2029-10-15		U-1123, U-1124

ATC Codes

A: Alimentary tract and metabolism drugs

— A08: Antiobesity preparations, excl. diet products

— A08A: Antiobesity preparations, excl. diet products

— A08AA: Centrally acting antiobesity products

— A08AA62: Bupropion and naltrexone

N: Nervous system drugs

— N02: Analgesics

— N02A: Opioid analgesics

— N02AA: Natural opium alkaloid analgesics

— N02AA56: Oxycodone and naltrexone

— N07: Other nervous system drugs in atc

— N07B: Drugs used in addictive disorders

— N07BB: Drugs used in alcohol dependence

— N07BB04: Naltrexone

HCPCS

Code	Description
G2073	Medication assisted treatment, naltrexone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
J2212	Injection, methylnaltrexone, 0.1 mg
J2315	Injection, naltrexone, depot form, 1 mg

Clinical

Clinical Trials

531 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Alcoholism	D000437	EFO_0003829	F10.1	13	31	24	47	12	122
Opioid-related disorders	D009293	EFO_0005611	F11	16	46	32	10	30	115
Obesity	D009765	EFO_0001073	E66.9	1	11	14	16	7	42
Substance-related disorders	D019966	EFO_0003890	F13	2	16	7	4	11	34
Alcohol drinking	D000428	EFO_0004329	—	7	11	5	10	4	32
Healthy volunteers/patients	—	—	—	22	2	—	2	1	26
Depression	D003863	—	F33.9	4	4	4	6	1	18
Overweight	D050177	—	E66.3	—	7	9	2	2	17
Hiv infections	D015658	EFO_0000764	B20	2	8	3	3	3	15
Depressive disorder	D003866	EFO_1002014	F32.A	4	4	3	5	—	15

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cocaine-related disorders	D019970	—	F14	2	11	4	—	2	17
Recurrence	D012008	—	—	1	5	3	—	2	9
Bulimia	D002032	—	F50.2	2	6	6	—	1	9
Addictive behavior	D016739	EFO_0004347	—	1	4	1	—	1	6
Migraine disorders	D008881	EFO_0003821	G43	—	5	1	—	1	6
Binge-eating disorder	D056912	—	F50.2	—	5	5	—	1	6
Analgesia	D000698	—	—	3	—	1	—	—	4
Low back pain	D017116	—	M54.5	—	2	1	—	—	3
Back pain	D001416	—	M54	—	2	1	—	—	3
Nerve compression syndromes	D009408	—	—	—	—	3	—	—	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	U07.1	1	4	—	—	—	5
Breast neoplasms	D001943	EFO_0003869	C50	—	3	—	—	1	4
Marijuana abuse	D002189	EFO_0007191	F12	1	4	—	—	—	4
Weight gain	D015430	—	—	2	2	—	—	1	3
Fatigue	D005221	—	R53.83	—	2	—	—	1	3
Atopic dermatitis	D003876	EFO_0000274	L20	1	2	—	—	—	3
Eczema	D004485	—	L30.9	1	2	—	—	—	3
Dermatitis	D003872	—	L30.9	1	2	—	—	—	3
Chronic fatigue syndrome	D015673	EFO_0004540	G93.31	—	2	—	—	1	3
Crohn disease	D003424	EFO_0000384	K50	—	3	—	—	—	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	4	—	—	—	—	4
Biological availability	D001682	—	—	2	—	—	—	1	3
Treatment-resistant depressive disorder	D061218	—	—	2	—	—	—	1	3
Pain management	D059408	—	—	1	—	—	—	—	1
Cognition	D003071	EFO_0003925	—	1	—	—	—	—	1
Postoperative pain	D010149	—	G89.18	1	—	—	—	—	1
Narcotic-related disorders	D000079524	—	—	1	—	—	—	—	1
Intestinal obstruction	D007415	—	K56.60	1	—	—	—	—	1
Renal insufficiency	D051437	—	N19	1	—	—	—	—	1
Psoriasis	D011565	EFO_0000676	L40	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Disease	D004194	EFO_0000408	R69	—	—	—	—	1	1
Neonatal abstinence syndrome	D009357	EFO_0005799	P96.1	—	—	—	—	1	1
High-risk pregnancy	D018566	—	—	—	—	—	—	1	1
Self concept	D012649	—	—	—	—	—	—	1	1
Psychological distance	D012929	—	—	—	—	—	—	1	1
Social psychology	D011593	—	—	—	—	—	—	1	1
Temporomandibular joint disorders	D013705	—	M26.6	—	—	—	—	1	1
Facial pain	D005157	—	R51.9	—	—	—	—	1	1
Temporomandibular joint dysfunction syndrome	D013706	—	—	—	—	—	—	1	1
Tuberculosis	D014376	EFO_0000774	A15-A19	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Naltrexone
INN	naltrexone
Description	Naltrexone is an organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence. It has a role as a mu-opioid receptor antagonist, a central nervous system depressant, an environmental contaminant, a xenobiotic and an antidote to opioid poisoning. It is an organic heteropentacyclic compound, a morphinane-like compound and a member of cyclopropanes. It is a conjugate base of a naltrexone(1+).
Classification	Small molecule
Drug class	narcotic agonists/antagonists (normorphine type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	O=C1CC[C@@]2(O)[C@H]3Cc4ccc(O)c5c4[C@@]2(CCN3CC2CC2)[C@H]1O5

Identifiers

PDB	—
CAS-ID	16590-41-3
RxCUI	—
ChEMBL ID	CHEMBL19019
ChEBI ID	7465
PubChem CID	5360515
DrugBank	DB00704
UNII ID	5S6W795CQM (ChemIDplus, GSRS)

Target

Agency Approved

OPRM1

OPRD1

OPRK1

Organism

Homo sapiens

Gene name

OPRM1

Gene synonyms

MOR1

NCBI Gene ID

4988

Protein name

mu-type opioid receptor

Protein synonyms

hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a

Uniprot ID

Q9UN57

Mouse ortholog

Oprm1 (18390)

mu-type opioid receptor (Q9R1M0)

Alternate

No data

Variants

No data

Financial

Revenue by drug

€

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Vivitrol – Alkermes

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Estimated US medical usage

Naltrexone

Morphine

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Naltrexone

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 20,496 documents

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Safety

Black-box Warning

Black-box warning for: Contrave, Trexall

Adverse Events

Top Adverse Reactions

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33,700 adverse events reported

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