ALTU-135

Identification

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Name
ALTU-135
Accession Number
DB05330
Type
Biotech
Groups
Investigational
Biologic Classification
Protein Based Therapies
Other protein based therapies
Description

ALTU-135, the Company's orally administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 has been granted orphan drug and fast-track designation as well as CMA Pilot 2 program status by the Food and Drug Administration (FDA).

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
Not Available
International/Other Brands
TheraCLEC / Trizytek
Categories
UNII
Not Available
CAS number
Not Available

Pharmacology

Indication

Investigated for use/treatment in cystic fibrosis and pancreatic disorders.

Pharmacodynamics
Not Available
Mechanism of action

As ALTU-135 consists of three enzymes, lipase, protease and amylase that are delivered in a consistent ratio and is designed to improve fat, protein, and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 is designed to be highly concentrated, stable and pure and to allow patients to take a single capsule per meal or snack, whereas current products are derived from pig pancreases and require a significantly higher pill burden. This reduced pill burden for ALTU-135 is expected to provide greater convenience for the patient and result in improved compliance and therefore effectiveness. ALTU-135 has been granted Orphan Drug designation in the United States and Europe. ALTU-135 was also granted fast track designation by the U.S. Food and Drug Administration (FDA) in November 2003, and was accepted into the FDA’s Continuous Marketing Application Pilot 2 Program in February 2004.

Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life
Not Available
Clearance
Not Available
Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

References

General References
Not Available
External Links
PubChem Substance
347910086

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2CompletedTreatmentCystic Fibrosis (CF) / Pancreatic Insufficiency1
3CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
3TerminatedTreatmentExocrine Pancreatic Insufficiency1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Drug created on November 18, 2007 11:23 / Updated on December 02, 2019 07:10