Isoniazid
Hyzyd, Inh, Laniazid, Nydrazid, Rifamate, Rifater, Rimifon, Stanozide (isoniazid) is a small molecule pharmaceutical. Isoniazid was first approved as Nydrazid on 1982-01-01. It is used to treat mycobacterium infections and tuberculosis in the USA.
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Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isoniazid
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NYDRAZID | Bristol Myers Squibb | N-008392 DISCN | 1982-01-01 | 1 products |
ISONIAZID | Epic Pharma | N-008678 DISCN | 1982-01-01 | 2 products, RLD |
ISONIAZID | Eli Lilly | N-008499 DISCN | 1982-01-01 | 2 products |
ISONIAZID | Panray Corporation | N-008428 DISCN | 1982-01-01 | 3 products |
RIMIFON | Roche | N-008420 DISCN | 1982-01-01 | 3 products |
NYDRAZID | Sandoz | N-008662 DISCN | 1982-01-01 | 1 products |
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Isoniazid
+
Pyrazinamide
+
Rifampin
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
RIFATER | Sanofi | N-050705 DISCN | 1994-05-31 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
isoniazid | ANDA | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
mycobacterium infections | — | D009164 | A31.9 |
tuberculosis | EFO_0000774 | D014376 | A15-A19 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AC: Hydrazides for tuberculosis treatment
— J04AC01: Isoniazid
— J04AC51: Isoniazid, combinations
— J04AM: Combinations of drugs for treatment of tuberculosis
— J04AM01: Streptomycin and isoniazid
— J04AM02: Rifampicin and isoniazid
— J04AM03: Ethambutol and isoniazid
— J04AM04: Thioacetazone and isoniazid
— J04AM05: Rifampicin, pyrazinamide and isoniazid
— J04AM06: Rifampicin, pyrazinamide, ethambutol and isoniazid
— J04AM07: Rifampicin, ethambutol and isoniazid
— J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
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Clinical
Clinical Trials
150 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 14 | 22 | 22 | 11 | 15 | 76 |
Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 6 | 7 | 6 | 8 | 27 |
Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 10 | 9 | 5 | 5 | 27 |
Latent tuberculosis | D055985 | Z22.7 | 3 | 2 | 8 | 6 | 2 | 19 | |
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | 2 | — | 3 |
Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | — | 2 | — | 2 |
Hiv seropositivity | D006679 | 1 | 1 | — | 1 | — | 2 | ||
Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | 1 | — | 1 |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv | D006678 | O98.7 | 1 | 2 | 4 | — | 1 | 8 | |
Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | 1 | 2 | 5 | — | — | 6 | |
Extensively drug-resistant tuberculosis | D054908 | — | 1 | 2 | — | — | 2 | ||
Anterior uveitis | D014606 | EFO_1000811 | — | — | 1 | — | — | 1 | |
Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | 1 | — | — | 1 |
Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 | |
Female infertility | D007247 | EFO_0008560 | N97 | — | — | 1 | — | — | 1 |
Female genital tuberculosis | D014384 | EFO_1000935 | — | — | 1 | — | — | 1 | |
Male genital tuberculosis | D014389 | EFO_1001030 | — | — | 1 | — | — | 1 | |
Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Meningeal tuberculosis | D014390 | A17.0 | — | 1 | — | — | 1 | 2 | |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ISONIAZID |
INN | isoniazid |
Description | Isoniazide is a carbohydrazide obtained by formal condensation between pyridine-4-carboxylic acid and hydrazine. It has a role as an antitubercular agent and a drug allergen. It is functionally related to an isonicotinic acid. |
Classification | Small molecule |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | NNC(=O)c1ccncc1 |
Identifiers
PDB | — |
CAS-ID | 54-85-3 |
RxCUI | 6038 |
ChEMBL ID | CHEMBL64 |
ChEBI ID | 6030 |
PubChem CID | 3767 |
DrugBank | DB00951 |
UNII ID | V83O1VOZ8L (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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12,976 adverse events reported
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