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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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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
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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
Hide discontinued
Naltrexone hydrochloride
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
TROXYCA ERPfizerN-207621 DISCN2016-08-19
6 products
Hide discontinued
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
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
contraveNew Drug Application2025-05-07
naltrexoneunapproved drug other2018-03-19
naltrexone hydrochlorideANDA2025-05-21
naltrexone hyrdochlorideANDA2009-07-21
trexallANDA2021-04-30
vivitrolNew Drug Application2024-05-22
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
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
AlcoholismD000437EFO_0003829F10.11331244712122
Opioid-related disordersD009293EFO_0005611F111646321030115
ObesityD009765EFO_0001073E66.91111416742
Substance-related disordersD019966EFO_0003890F13216741134
Alcohol drinkingD000428EFO_0004329711510432
Healthy volunteers/patients2222126
DepressionD003863F33.94446118
OverweightD050177E66.3792217
Hiv infectionsD015658EFO_0000764B202833315
Depressive disorderD003866EFO_1002014F32.A443515
Show 73 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970F142114217
RecurrenceD01200815329
BulimiaD002032F50.226619
Addictive behaviorD016739EFO_000434714116
Migraine disordersD008881EFO_0003821G435116
Binge-eating disorderD056912F50.25516
AnalgesiaD000698314
Low back painD017116M54.5213
Back painD001416M54213
Nerve compression syndromesD00940833
Show 21 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.1145
Breast neoplasmsD001943EFO_0003869C50314
Marijuana abuseD002189EFO_0007191F12144
Weight gainD0154302213
FatigueD005221R53.83213
Atopic dermatitisD003876EFO_0000274L20123
EczemaD004485L30.9123
DermatitisD003872L30.9123
Chronic fatigue syndromeD015673EFO_0004540G93.31213
Crohn diseaseD003424EFO_0000384K5033
Show 72 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059944
Biological availabilityD001682213
Treatment-resistant depressive disorderD061218213
Pain managementD05940811
CognitionD003071EFO_000392511
Postoperative painD010149G89.1811
Narcotic-related disordersD00007952411
Intestinal obstructionD007415K56.6011
Renal insufficiencyD051437N1911
PsoriasisD011565EFO_0000676L4011
Show 1 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DiseaseD004194EFO_0000408R6911
Neonatal abstinence syndromeD009357EFO_0005799P96.111
High-risk pregnancyD01856611
Self conceptD01264911
Psychological distanceD01292911
Social psychologyD01159311
Temporomandibular joint disordersD013705M26.611
Facial painD005157R51.911
Temporomandibular joint dysfunction syndromeD01370611
TuberculosisD014376EFO_0000774A15-A1911
Show 18 more
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
Protein name
mu-type opioid receptor
Protein synonyms
hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a
Uniprot ID
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 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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