Lactitol - PharmaKB

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

Events Timeline

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YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Commercial

Therapeutic Areas

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EMA

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Drug Products

FDA

EMA

New Drug Application (NDA)

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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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

ATC Codes

A: Alimentary tract and metabolism drugs

— A06: Drugs for constipation

— A06A: Drugs for constipation

— A06AD: Osmotically acting laxatives

— A06AD12: Lactitol

HCPCS

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Clinical

Clinical Trials

432 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	42	1	1	1	6	51
Meningococcal infections	D008589	EFO_0004249	A39	—	18	26	2	2	46
Meningitis	D008581	EFO_0000584	G03	—	7	21	1	—	27
Malaria	D008288	EFO_0001068	B54	1	1	7	9	6	23
Human influenza	D007251	EFO_0007328	J11.1	3	9	6	2	3	23
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	—	—	10	7	1	18
Obstructive lung diseases	D008173	—	—	—	—	9	5	—	14
Neoplasms	D009369	—	C80	3	7	1	4	—	13
Falciparum malaria	D016778	EFO_0007444	B50	1	1	3	6	2	12
Breast neoplasms	D001943	EFO_0003869	C50	1	3	3	2	3	12

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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	—	7	19	—	—	24
Influenza in birds	D005585	—	J09.X	2	2	1	—	—	5
Osteoarthritis	D010003	EFO_0002506	M15-M19	—	—	4	—	—	4
Eye diseases	D005128	EFO_0003966	H44	1	1	2	—	—	3
Knee osteoarthritis	D020370	EFO_0004616	M17	—	—	3	—	—	3
Hypertension	D006973	EFO_0000537	I10	—	—	1	—	2	3
Fever	D005334	—	R50.9	—	—	1	—	1	2
Hypoglycemia	D007003	—	E16.2	1	—	1	—	—	2
Whooping cough	D014917	EFO_0000650	A37	—	1	1	—	—	2
Chronic pain	D059350	—	—	—	2	2	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Central serous chorioretinopathy	D056833	—	H35.71	1	1	—	—	5	6
Myelodysplastic syndromes	D009190	—	D46	2	4	—	—	—	4
Stroke	D020521	EFO_0000712	I63.9	—	3	—	—	1	4
Renal cell carcinoma	D002292	EFO_0000376	—	—	3	—	—	—	3
Triple negative breast neoplasms	D064726	—	—	1	1	—	—	1	3
Ischemic stroke	D000083242	—	—	—	3	—	—	—	3
Myelomonocytic leukemia chronic	D015477	—	C93.1	1	2	—	—	—	2
Kidney neoplasms	D007680	EFO_0003865	C64	—	2	—	—	—	2
Hematologic neoplasms	D019337	—	—	—	2	—	—	—	2
Head and neck neoplasms	D006258	—	—	1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Malnutrition	D044342	EFO_0008572	E40-E46	4	—	—	—	3	7
Social psychology	D011593	—	—	3	—	—	—	—	3
Beta-thalassemia	D017086	Orphanet_848	D56.1	1	—	—	—	1	2
Infections	D007239	EFO_0000544	—	1	—	—	—	1	2
Fasting	D005215	EFO_0002756	—	2	—	—	—	—	2
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Small cell lung carcinoma	D055752	—	—	1	—	—	—	—	1
Congenital hyperinsulinism	D044903	—	—	1	—	—	—	—	1
Nesidioblastosis	D046768	EFO_0007318	E16.9	1	—	—	—	—	1
Immune system diseases	D007154	—	D89.9	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Embryo transfer	D004624	—	—	—	—	—	—	3	3
Uveitis	D014605	EFO_1001231	H20.9	—	—	—	—	2	2
Obstetric labor complications	D007744	—	—	—	—	—	—	2	2
Therapeutic equivalency	D013810	—	—	—	—	—	—	2	2
Wounds and injuries	D014947	—	T14.8	—	—	—	—	1	1
Angioid streaks	D000793	EFO_1000805	—	—	—	—	—	1	1
Myopia	D009216	EFO_0003927	H52.1	—	—	—	—	1	1
White dot syndromes	D000080363	—	H30.14	—	—	—	—	1	1
Multifocal choroiditis	D000080364	—	—	—	—	—	—	1	1
Hereditary eye diseases	D015785	—	—	—	—	—	—	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