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Drug ReportsNaltrexone
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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 diseasesD009750
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
diagnosisD003933
mental disordersD001523
physiological phenomenaD010829
Trade Name
FDA
EMA
Naltrexone, Vivitrol (discontinued: Naltrexone, Revia)
Combinations
Contrave (discontinued: Embeda, Troxyca)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Morphine sulfate
+
Naltrexone hydrochloride
Tradename
Company
Number
Date
Products
EMBEDAAlpharmaN-022321 DISCN2009-08-13
6 products, RLD
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Naltrexone hydrochloride
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
TROXYCA ERPfizerN-207621 DISCN2016-08-19
6 products
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Naltrexone
Tradename
Company
Number
Date
Products
VIVITROLAlkermesN-021897 RX2006-04-13
1 products, RLD, RS
Bupropion hydrochloride
+
Naltrexone hydrochloride
Tradename
Company
Number
Date
Products
CONTRAVENalpropion PharmaceuticalsN-200063 RX2014-09-10
1 products, RLD, RS
Naltrexone hydrochloride
Tradename
Company
Number
Date
Products
REVIATevaN-018932 DISCN1984-11-20
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
contraveNew Drug Application2024-05-21
embedaNew Drug Application2010-01-22
naltrexoneunapproved drug other2018-03-19
naltrexone hydrochlorideANDA2024-12-26
naltrexone hyrdochlorideANDA2009-07-21
trexallANDA2021-04-30
vivitrolNew Drug Application2024-05-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
alcoholismEFO_0003829D000437F10.1
opioid-related disordersEFO_0005611D009293F11
dyspneaHP_0002094D004417R06.0
drug overdose—D062787—
intractable pain—D010148—
postoperative pain—D010149G89.18
tobacco use disorder—D014029F17
attention deficit disorder with hyperactivityEFO_0003888D001289F90
depressive disorderEFO_1002014D003866F32.A
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Bupropion Hydrochloride / Naltrexone Hydrochloride, Contrave, Nalpropion
102319642034-07-02U-1583
108282942034-07-02U-1583
108355272034-07-02U-1583
96335752033-06-25U-1583
104031702033-06-05U-1583
111390562033-06-05U-1583
92481232032-01-13U-1808
110335432031-01-10U-1583
89161952030-02-02U-1639
113247412029-05-29U-1583
80887862029-02-03DP
83187882027-11-08U-1584
87220852027-11-08U-1585
91258682027-11-08U-1585
103073762027-11-08U-1585
91078372027-06-04U-1639
73751112025-03-26DP
74626262024-07-20U-1583
88158892024-07-20U-1586
112785442024-04-21U-1583
Morphine Sulfate / Naltrexone Hydrochloride, Embeda, Alpharma Pharms
86234182029-11-07U-1640
78159342027-12-12DP
76826332027-06-19U-1510
76826342027-06-19DP
81581562027-06-19U-1510
88461042027-06-19DP
88772472027-06-19DP
86854432025-07-03U-1508
86854442025-07-03DP
Naltrexone, Vivitrol, Alkermes
79194992029-10-15U-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
2464 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9—362—11
Cardiovascular diseasesD002318HP_0001626————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OverweightD050177—E66.3—36——9
Body weightD001835EFO_0004338———1——1
Type 2 diabetes mellitusD003924EFO_0001360E11——1——1
Diabetes mellitusD003920HP_0000819E08-E13——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9—1———1
Depressive disorderD003866EFO_1002014F32.A—1———1
Tobacco use disorderD014029—F17—1———1
Obsessive-compulsive disorderD009771EFO_0004242F42—1———1
Compulsive personality disorderD003193—F60.5—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNaltrexone
INNnaltrexone
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 classnarcotic agonists/antagonists (normorphine type)
Image (chem structure or protein)Loading
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-ID16590-41-3
RxCUI—
ChEMBL IDCHEMBL19019
ChEBI ID7465
PubChem CID5360515
DrugBankDB00704
UNII ID5S6W795CQM (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
OPRM1
OPRD1
OPRD1
OPRK1
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
$
€
£
₣
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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Number of purchases
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Refill frequency
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Price per prescription (USD)
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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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 19,670 documents
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Safety
Black-box Warning
Black-box warning for: Contrave, Embeda, Trexall
Adverse Events
Top Adverse Reactions
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32,796 adverse events reported
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