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Crofelemer
Mytesi (crofelemer) is a small molecule pharmaceutical. Crofelemer was first approved as Mytesi on 2012-12-31. It is used to treat diarrhea in the USA. The pharmaceutical is active against anoctamin-1 and cystic fibrosis transmembrane conductance regulator.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Mytesi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Crofelemer
Tradename
Company
Number
Date
Products
MYTESINapo PharmaceuticalsN-202292 RX2012-12-31
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mytesiNew Drug Application2020-11-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
diarrheaHP_0002014D003967R19.7
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Crofelemer, Mytesi, Napo Pharms Inc
89626802031-10-31U-1319
95858682031-10-31U-1319
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07X: Other antidiarrheals in atc
— A07XA: Other antidiarrheals in atc
— A07XA06: Crofelemer
HCPCS
No data
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pituitary neoplasmsD0109111———12
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pituitary acth hypersecretionD047748EFO_1001110E24.0————11
Cocaine-related disordersD019970F14————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCROFELEMER
INN—
Description
Crofelemer (USAN, trade name Mytesi) is an antidiarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Other possible uses include diarrhea in children, acute infectious diarrhea, and diarrhea in patients with irritable bowel syndrome. It is a purified oligomeric proanthocyanidin from "dragon's blood", the sap of the South American tree Croton lechleri.
Classification
Small molecule
Drug classpolymers
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID148465-45-6
RxCUI1364449
ChEMBL IDCHEMBL2108184
ChEBI ID—
PubChem CID—
DrugBankDB04941
UNII ID—
Target
Agency Approved
ANO1
ANO1
CFTR
CFTR
Organism
Homo sapiens
Gene name
ANO1
Gene synonyms
DOG1, ORAOV2, TAOS2, TMEM16A
NCBI Gene ID
55107
Protein name
anoctamin-1
Protein synonyms
anoctamin 1, calcium activated chloride channel, Ca2+-activated Cl- channel, calcium activated chloride channel, Discovered on gastrointestinal stromal tumors protein 1, oral cancer overexpressed 2, Oral cancer overexpressed protein 2, Transmembrane protein 16A, transmembrane protein 16A (eight membrane-spanning domains), Tumor-amplified and overexpressed sequence 2
Uniprot ID
Q8N7V3
Mouse ortholog
Ano1 (101772)
anoctamin-1 (Q99JK1)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Mytesi - Jaguar Health, Inc.
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 166 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6 adverse events reported
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