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Lactitol
Pizensy (lactitol) is a small molecule pharmaceutical. Lactitol was first approved as Pizensy on 2020-02-12.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
No data
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)
Lactitol
Tradename
Company
Number
Date
Products
PIZENSYBraintree LaboratoriesN-211281 DISCN2020-02-12
1 products, RLD
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Labels
FDA
EMA
No data
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
LACTITOL, PIZENSY, BRAINTREE LABS
2025-02-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Lactitol, Pizensy, Braintree Labs
108067432037-05-12U-1516
ATC Codes
A: Alimentary tract and metabolism drugs
A06: Drugs for constipation
A06A: Drugs for constipation
A06AD: Osmotically acting laxatives
A06AD12: Lactitol
HCPCS
No data
Clinical
Clinical Trials
39 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Meningococcal infectionsD008589EFO_0004249A3912126
Polycystic ovary syndromeD011085EFO_0000660E28.2112
SepsisD018805A41.911
MeningitisD008581EFO_0000584G0311
Female infertilityD007247EFO_0008560N9711
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Meningococcal meningitisD008585EFO_1001040A39.0134
Human influenzaD007251EFO_0007328J11.1123
ConstipationD003248HP_0002019K59.0123
Influenza in birdsD005585J09.X11
H5n1 subtype influenza a virusD05312411
Dry eye syndromesD015352H04.1211
MalariaD008288EFO_0001068B5411
Papillomavirus infectionsD03036111
Whooping coughD014917EFO_0000650A3711
TetanusD013742EFO_0005593A3511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4611
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011
Macular degenerationD008268EFO_0001365H35.3011
LeprosyD007918EFO_0001054A30111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients33
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G3522
Falciparum malariaD016778EFO_0007444B5011
Pregnancy rateD01887311
Fecal impactionD005244K56.4111
Cardiovascular diseasesD002318EFO_0000319I9811
Type 2 diabetes mellitusD003924EFO_0001360E1111
Breast neoplasmsD001943EFO_0003869C5011
AsthmaD001249EFO_0000270J4511
Neisseria meningitidisD009345NCBITaxon_48711
ObesityD009765EFO_0001073E66.911
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLACTITOL
INNlactitol
Description
Lactitol is a glycosyl alditol consisting of beta-D-galactopyranose and D-glucitol joined by a 1->4 glycosidic bond. It is used as a laxative, as an excipient, and as replacement bulk sweetener in some low-calorie foods. It has a role as a laxative, an excipient and a cathartic.
Classification
Small molecule
Drug class
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
OC[C@H](O)[C@@H](O)[C@H](O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O)[C@H](O)CO
Identifiers
PDB
CAS-ID585-86-4
RxCUI28395
ChEMBL IDCHEMBL1661
ChEBI ID75323
PubChem CID157355
DrugBankDB12942
UNII IDL2B0WJF7ZY (ChemIDplus, GSRS)
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 1,088 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,080 adverse events reported
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