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AboutPricing
Drug ReportsIndigotindisulfonic acid
Indigotindisulfonate sodium
Bludigo (indigotindisulfonate sodium) is a small molecule pharmaceutical. Indigotindisulfonate sodium was first approved as Bludigo on 2022-07-08.
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Bludigo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indigotindisulfonate sodium
Tradename
Company
Number
Date
Products
BLUDIGOProvepharmN-216264 RX2022-07-08
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bludigoNew Drug Application2023-01-20
indigo carmineunapproved drug other2021-04-15
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
INDIGOTINDISULFONATE SODIUM, BLUDIGO, PROVEPHARM SAS
2027-07-08NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Indigotindisulfonate Sodium, Bludigo, Provepharm Sas
109272582037-12-23DP
114990502037-12-23DP
ATC Codes
V: Various drug classes in atc
— V04: Diagnostic agents
— V04C: Other diagnostic agents in atc
— V04CH: Renal function and ureteral injuries test diagnostic agents
— V04CH02: Indigo carmine
HCPCS
No data
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N19———1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain neoplasmsD001932EFO_0003833C7111———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIndigotindisulfonate sodium
INN—
Description
Indigo carmine, or 5,5′-indigodisulfonic acid sodium salt, is an organic salt derived from indigo by aromatic sulfonation, which renders the compound soluble in water. It is approved for use as a food colorant in the U.S and E.U. to produce a blue color. It has the E number E132. It is also a pH indicator.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
O=C1/C(=C2\Nc3ccc(S(=O)(=O)[O-])cc3C2=O)Nc2ccc(S(=O)(=O)[O-])cc21.[Na+].[Na+]
Identifiers
PDB—
CAS-ID860-22-0
RxCUI—
ChEMBL IDCHEMBL2105023
ChEBI ID31695
PubChem CID5284351
DrugBankDB11577
UNII ID—
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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21 adverse events reported
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