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Amantadine
Gocovri, Osmolex (amantadine) is a small molecule pharmaceutical. Amantadine was first approved as Symmetrel on 1982-01-01. It is used to treat drug-induced akathisia, drug-induced dyskinesia, dystonia, human influenza, and parkinson disease amongst others in the USA. The pharmaceutical is active against glutamate receptor ionotropic, NMDA 2C, glutamate receptor ionotropic, NMDA 2D, glutamate receptor ionotropic, NMDA 2B, and glutamate receptor ionotropic, NMDA 2A.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
Gocovri, Osmolex (generic drugs available since 1986-08-05, discontinued: Symadine, Symmetrel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amantadine hydrochloride
Tradename
Company
Number
Date
Products
GOCOVRIAdamas PharmaceuticalsN-208944 RX2017-08-24
2 products, RLD, RS
OSMOLEX ERAdamas PharmaceuticalsN-209410 RX2018-02-16
2 products, RLD
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amantadine hydrochlorideANDA2023-06-07
gocovriNew Drug Application2021-01-29
osmolex erNew Drug Application2021-10-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
drug-induced akathisiaEFO_1000903D017109G25.71
drug-induced dyskinesiaEFO_1000904D004409—
dystoniaHP_0001332D004421G24
human influenzaEFO_0007328D007251J11.1
parkinson diseaseEFO_0002508D010300G20
secondary parkinson diseaseEFO_1001175D010302G21
Agency Specific
FDA
EMA
Expiration
Code
AMANTADINE HYDROCHLORIDE, GOCOVRI, ADAMAS OPERATIONS
2024-08-24ODE-153
Patent Expiration
Patent
Expires
Flag
FDA Information
Amantadine Hydrochloride, Gocovri, Adamas Operations
110652132038-08-23DP
110770732038-08-23U-2106, U-2224, U-3180
101549712034-12-04U-2459
106464562034-06-17U-2808
87413432030-12-02U-2106
98677912030-12-02U-2106
98677922030-12-02U-2106
98677932030-12-02U-2106
98779332030-12-02U-2224
111978352030-12-02U-2106
83895782028-01-22U-219, U-2105, U-3054
87963372025-11-23U-219, U-2106, U-2497, U-3054
88897402025-11-23DP
88956142025-11-23DP
88956152025-11-23U-219, U-2106, U-3054
88956162025-11-23U-219, U-2106, U-3054
88956172025-11-23U-219, U-2106, U-3054
88956182025-11-23DP
Amantadine Hydrochloride, Osmolex Er, Adamas Operations
102133932038-02-15U-20
102133942038-02-15U-2497
105001702038-02-15U-20
105001712038-02-15U-2497
105001722038-02-15U-2497
105126172038-02-15U-2497
82523312030-03-13DP
85746262025-11-28DPU-20
89873332025-11-23DP
90726972025-11-23U-219, U-3054
ATC Codes
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04B: Dopaminergic agents
— N04BB: Adamantane derivatives, dopaminergic
— N04BB01: Amantadine
HCPCS
No data
Clinical
Clinical Trials
1019 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.1234361569
Type 2 diabetes mellitusD003924EFO_0001360E11125221343
NeoplasmsD009369C8012931324
Human influenzaD007251EFO_0007328J11.191043123
MalariaD008288EFO_0001068B54193—2—21
Acne vulgarisD000152EFO_0003894L704156116
Falciparum malariaD016778EFO_0007444B507313—13
HyperphosphatemiaD054559HP_0002905—143613
Postoperative painD010149G89.18—114410
Covid-19D000086382U07.143—2210
Show 60 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4651978—14149
LeukemiaD007938C95378313—10122
LymphomaD008223C85.927614—1596
Myeloid leukemia acuteD015470C92.042585—595
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.029434—472
Non-hodgkin lymphomaD008228C85.920361—554
Multiple myelomaD009101C90.019312—652
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034010332—343
Hodgkin diseaseD006689C8113264—441
Large b-cell lymphoma diffuseD016403C83.312212—333
Show 93 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Plasma cell neoplasmsD0542191428——644
MelanomaD0085451319———29
Burkitt lymphomaD002051C83.7614——321
B-cell lymphoma marginal zoneD018442C88.4711——420
Primary myelofibrosisD055728D47.4511——218
Large-cell lymphoma anaplasticD017728C84.6513——318
Large-cell lymphoma immunoblasticD016400511——317
Healthy volunteers/patients—123——416
Lymphomatoid granulomatosisD008230C83.8411——316
Extranodal nk-t-cell lymphomaD054391C86.0410——315
Show 130 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DengueD003715A906————6
PlasmacytomaD010954C90.31———12
Pancreatic neoplasmsD010190EFO_0003860C251———12
RicketsD012279EFO_0005583E55.01———12
Triple negative breast neoplasmsD0647261———12
Hepatic insufficiencyD0485502————2
Gram-positive bacterial infectionsD0169082————2
Hiv seronegativityD0180232————2
DepressionD003863F33.92————2
Beta-thalassemiaD017086Orphanet_848D56.11————1
Show 34 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sars-cov-2D000086402————22
AnxietyD001007EFO_0005230F41.1————22
Sinus floor augmentationD059546————22
Cardiovascular diseasesD002318EFO_0000319I98————22
PapillomaviridaeD027383————11
Peptic ulcerD010437HP_0004398K27————11
UlcerD014456MPATH_579————11
DermatitisD003872HP_0011123L30.9————11
Sexual behaviorD012725————11
Hypertrophic cicatrixD017439L91.0————11
Show 47 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMANTADINE
INNamantadine
Description
Amantadine is a member of the class of adamantanes that is used as an antiviral and antiparkinson drug. It has a role as an antiviral drug, an antiparkinson drug, a dopaminergic agent, an analgesic, a NMDA receptor antagonist and a non-narcotic analgesic. It is a primary aliphatic amine and a member of adamantanes. It is a conjugate base of an adamantan-1-aminium. It derives from a hydride of an adamantane.
Classification
Small molecule
Drug classantivirals/antiparkinsonians (adamantane derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NC12CC3CC(CC(C3)C1)C2
Identifiers
PDB6BKK
CAS-ID768-94-5
RxCUI620
ChEMBL IDCHEMBL660
ChEBI ID2618
PubChem CID2130
DrugBankDB00915
UNII IDBF4C9Z1J53 (ChemIDplus, GSRS)
Target
Agency Approved
GRIN2C
GRIN2C
GRIN2D
GRIN2D
GRIN2B
GRIN2B
GRIN2A
GRIN2A
Organism
Homo sapiens
Gene name
GRIN2C
Gene synonyms
NMDAR2C
NCBI Gene ID
2905
Protein name
glutamate receptor ionotropic, NMDA 2C
Protein synonyms
GluN2C(alt_5'UTR_77nt), GluN2C(alt_5'UTR_87nt), GluN2C(del_e2), GluN2C-b alternative isoform, Glutamate [NMDA] receptor subunit epsilon-3, glutamate receptor, ionotropic, N-methyl D-aspartate 2C, N-methyl D-aspartate receptor subtype 2C, N-methyl-D-aspartate receptor subunit 2C, NMDAR2C, NR2C, putative NMDtranscript(altAcc_e11), putative NMDtranscript(altDon_e4), putative NMDtranscript(del_e4)
Uniprot ID
Q14957
Mouse ortholog
Grin2c (14813)
glutamate receptor ionotropic, NMDA 2C (Q01098)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Osmolex - RVL Pharmaceuticals
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Osmolex - Supernus Pharmaceuticals
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Gocovri - Supernus Pharmaceuticals
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,195 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,846 adverse events reported
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