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Drug ReportsPentamidine isethionate
Pentamidine isethionate
Nebupent, Pentam, Pentamidine Isethionate (pentamidine isethionate) is a small molecule pharmaceutical. Pentamidine isethionate was first approved as Pentam on 1984-10-16. It is used to treat pneumocystis pneumonia, protozoan infections, trypanosomiasis, and visceral leishmaniasis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Nebupent, Pentam, Pentamidine isethionate (discontinued: Nebupent, Pentacarinat, Pentamidine isethionate)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pentamidine isethionate
Tradename
Company
Number
Date
Products
NEBUPENTFresenius KabiN-019887 RX1989-06-15
1 products, RLD, RS
PENTAMFresenius KabiN-019264 RX1984-10-16
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
nebupentNew Drug Application2024-10-15
pentam 300New Drug Application2022-09-13
pentamidine isethionateANDA2024-03-18
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01C: Agents against leishmaniasis and trypanosomiasis
— P01CX: Other agents against leishmaniasis and trypanosomiasis in atc
— P01CX01: Pentamidine isethionate
HCPCS
Code
Description
J2545
Pentamidine isethionate, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per 300 mg
J7676
Pentamidine isethionate, inhalation solution, compounded product, administered through dme, unit dose form, per 300 mg
S0080
Injection, pentamidine isethionate, 300 mg
Clinical
Clinical Trials
47 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106—21711223
Pneumocystis pneumoniaD011020EFO_0007448B5921711223
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20218—1122
LeishmaniasisD007896EFO_0005044B55—43—17
Acquired immunodeficiency syndromeD000163EFO_0000765B201—3—15
InfectionsD007239EFO_0000544—1—2—14
Cutaneous leishmaniasisD016773—B55.1—31—14
LymphomaD008223—C85.9111——3
Visceral leishmaniasisD007898—B55.0——2——2
Hodgkin diseaseD006689—C811—1——2
Communicable diseasesD003141————1—12
Hiv seropositivityD006679————1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——12———2
Kidney diseasesD007674EFO_0003086N0822———2
Kidney transplantationD016030——22———2
Colonic neoplasmsD003110—C1811———1
NeuroblastomaD009447EFO_0000621—11———1
GliomaD005910EFO_0000520—11———1
MedulloblastomaD008527——11———1
RhabdomyosarcomaD012208——11———1
AstrocytomaD001254EFO_0000271—11———1
HepatoblastomaD018197—C22.211———1
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Fatty liverD005234EFO_0003934—1————1
Alcoholic fatty liverD005235—K70.01————1
CarcinomaD002277—C80.01————1
Hepatocellular carcinomaD006528—C22.01————1
Liver neoplasmsD008113EFO_1001513C22.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337——————11
NeoplasmsD009369—C80————11
Pneumocystis infectionsD016720EFO_0007447—————11
Drug evaluationD004341——————11
Treatment adherence and complianceD000074822——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePentamidine isethionate
INNpentamidine
Description
Pentamidine is a diether consisting of pentane-1,5-diol in which both hydroxyl hydrogens have been replaced by 4-amidinophenyl groups. A trypanocidal drug that is used for treatment of cutaneous leishmaniasis and Chagas disease. It has a role as a trypanocidal drug, an antifungal agent, a NMDA receptor antagonist, an anti-inflammatory agent, a chemokine receptor 5 antagonist, an EC 2.3.1.48 (histone acetyltransferase) inhibitor, a calmodulin antagonist, a S100 calcium-binding protein B inhibitor and a xenobiotic. It is a carboxamidine, a diether and an aromatic ether. It is a conjugate base of a pentamidinium(2+).
Classification
Small molecule
Drug classpentamidine derivatives/analogues
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Structure (InChI/SMILES or Protein Sequence)
N=C(N)c1ccc(OCCCCCOc2ccc(C(=N)N)cc2)cc1.O=S(=O)(O)CCO.O=S(=O)(O)CCO
Identifiers
PDB—
CAS-ID140-64-7
RxCUI—
ChEMBL IDCHEMBL361506
ChEBI ID7977
PubChem CID4735
DrugBankDB00738
UNII ID673LC5J4LQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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806 adverse events reported
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