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
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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 |
|---|---|---|---|---|
| BLUDIGO | Provepharm | N-216264 RX | 2022-07-08 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bludigo | New Drug Application | 2023-01-20 |
| indigo carmine | unapproved drug other | 2021-04-15 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
INDIGOTINDISULFONATE SODIUM, BLUDIGO, PROVEPHARM SAS | |||
| 2027-07-08 | NCE | ||
HCPCS
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Clinical
Clinical Trials
108 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 neoplasms | D015179 | — | — | — | 1 | 1 | 1 | 8 | 11 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | 1 | 7 | 8 |
| Neoplasms | D009369 | — | C80 | — | — | — | 1 | 6 | 7 |
| Leukemia | D007938 | — | C95 | 1 | — | 3 | 1 | 1 | 6 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | — | 2 | 1 | 1 | 4 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | 1 | 2 | 3 |
| Ureteral obstruction | D014517 | HP_0006000 | — | — | — | — | 1 | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | — | — | 1 | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | 1 | — | 1 |
| Duodenal neoplasms | D004379 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 6 | 2 | — | 1 | 7 |
| Adenoma | D000236 | — | — | — | — | 1 | — | 5 | 6 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | — | — | 2 | — | — | 2 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | — | — | 2 | — | — | 2 |
| Enuresis | D004775 | — | R32 | — | — | 2 | — | — | 2 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | 1 | — | — | 2 |
| Recurrence | D012008 | — | — | — | — | 1 | — | 1 | 2 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | 1 | — | 1 | 2 |
| Stress urinary incontinence | D014550 | HP_0010992 | — | — | — | 1 | — | — | 1 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | — | 1 | — | — | 4 | 5 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 2 | — | — | — | 2 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | 2 | — | — | — | 2 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 2 | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 1 | — | — | — | 1 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | — | 1 | — | — | — | 1 |
| Rhabdomyosarcoma | D012208 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Embolism | D004617 | — | — | 1 | — | — | — | 5 | 6 |
| Colonic polyps | D003111 | — | K63.5 | 1 | — | — | — | 4 | 5 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | 1 | — | — | — | 4 | 5 |
| Hiv | D006678 | — | O98.7 | 1 | — | — | — | — | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 6 | 6 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 6 | 6 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | — | — | — | 6 | 6 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 4 | 4 |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | — | 4 | 4 |
| Syndrome | D013577 | — | — | — | — | — | — | 4 | 4 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 3 | 3 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | — | — | — | — | 3 | 3 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 3 | 3 |
| Polyps | D011127 | EFO_0000662 | — | — | — | — | — | 3 | 3 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Indigotindisulfonate 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-ID | 860-22-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105023 |
| ChEBI ID | 31695 |
| PubChem CID | 5284351 |
| DrugBank | DB11577 |
| UNII ID | — |
Target
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Variants
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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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34 adverse events reported
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