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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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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 Application2022-11-07
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
INDIGOTINDISULFONATE SODIUM, BLUDIGO, PROVEPHARM SAS
2027-07-08NCE
Patent Expiration
Patent
Expires
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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
32 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——11—2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Promyelocytic leukemia acuteD015473C92.4——2——2
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40—3———3
Atopic dermatitisD003876EFO_0000274L20—1———1
Brain neoplasmsD001932EFO_0003833C7111———1
Anus neoplasmsD001005EFO_0003835C21—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary embolismD011655EFO_0003827I261———23
Colonic polypsD003111K63.51———12
Myeloid leukemia acuteD015470C92.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD012004————11
Colonic neoplasmsD003110C18————11
ColonoscopyD003113————11
Inflammatory bowel diseasesD015212EFO_0003767————11
Ulcerative colitisD003093EFO_0000729K51————11
Lymphocytic colitisD046730EFO_1001294K52.832————11
Collagenous colitisD046729EFO_1001293K52.831————11
Venous thrombosisD020246HP_0004936I82.40————11
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—
Image (chem structure or protein)
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
RxCUI227312
ChEMBL IDCHEMBL2105023
ChEBI ID31695
PubChem CID5284351
DrugBankDB11577
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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