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
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Trade Name
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EMA
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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 |
|---|---|---|---|---|
| PIZENSY | Braintree Laboratories | N-211281 DISCN | 2020-02-12 | 1 products, RLD |
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FDA
EMA
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LACTITOL, PIZENSY, BRAINTREE LABS | |||
| 2025-02-12 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lactitol, Pizensy, Braintree Labs | |||
| 10806743 | 2037-05-12 | U-1516 | |
HCPCS
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Clinical
Clinical Trials
39 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningococcal infections | D008589 | EFO_0004249 | A39 | — | 1 | 2 | 1 | 2 | 6 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | 1 | 1 | 2 |
| Sepsis | D018805 | A41.9 | — | — | — | 1 | — | 1 | |
| Meningitis | D008581 | EFO_0000584 | G03 | — | — | — | 1 | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningococcal meningitis | D008585 | EFO_1001040 | A39.0 | — | 1 | 3 | — | — | 4 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | 1 | 2 | — | — | 3 |
| Constipation | D003248 | HP_0002019 | K59.0 | — | 1 | 2 | — | — | 3 |
| Influenza in birds | D005585 | J09.X | — | — | 1 | — | — | 1 | |
| H5n1 subtype influenza a virus | D053124 | — | — | 1 | — | — | 1 | ||
| Dry eye syndromes | D015352 | H04.12 | — | — | 1 | — | — | 1 | |
| Malaria | D008288 | EFO_0001068 | B54 | — | — | 1 | — | — | 1 |
| Papillomavirus infections | D030361 | — | — | 1 | — | — | 1 | ||
| Whooping cough | D014917 | EFO_0000650 | A37 | — | — | 1 | — | — | 1 |
| Tetanus | D013742 | EFO_0005593 | A35 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | — | 1 | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | 1 | |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Leprosy | D007918 | EFO_0001054 | A30 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 2 | 2 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Fecal impaction | D005244 | K56.41 | — | — | — | — | 1 | 1 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
| Neisseria meningitidis | D009345 | NCBITaxon_487 | — | — | — | — | 1 | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LACTITOL |
| INN | lactitol |
| 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-ID | 585-86-4 |
| RxCUI | 28395 |
| ChEMBL ID | CHEMBL1661 |
| ChEBI ID | 75323 |
| PubChem CID | 157355 |
| DrugBank | DB12942 |
| UNII ID | L2B0WJF7ZY (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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14,080 adverse events reported
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