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1. 258818-34-7
2. 258818-34-7 (free Base)
3. At-2347
4. 2-[[(2s)-1-[(2s)-5-amino-2-[[(2s)-2-[[(2s)-2-[[(2s)-2-[[2-[(2-aminoacetyl)amino]acetyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-3-methylbutanoyl]amino]-5-oxopentanoyl]pyrrolidine-2-carbonyl]amino]acetic Acid
5. Glycylglycyl-l-valyl-l-leucyl-l-valyl-l-glutaminyl-l-prolylglycine
6. Larazotide [usan:inn]
7. Unii-zn3r5560zv
8. Larazotide-acetate
9. At 2347
10. Larazotide (usan/inn)
11. Zn3r5560zv
12. Chembl2105646
13. Dtxsid30180526
14. Chebi:177799
15. Zinc68009799
16. Db05645
17. H-gly-gly-val-leu-val-gln-pro-gly-oh
18. Hy-106268
19. Cs-0025478
20. D09351
21. 818l347
22. Q27295752
| Molecular Weight | 725.8 g/mol |
|---|---|
| Molecular Formula | C32H55N9O10 |
| XLogP3 | -3.6 |
| Hydrogen Bond Donor Count | 9 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 21 |
| Exact Mass | 725.40718899 g/mol |
| Monoisotopic Mass | 725.40718899 g/mol |
| Topological Polar Surface Area | 301 Ų |
| Heavy Atom Count | 51 |
| Formal Charge | 0 |
| Complexity | 1290 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Investigated for use/treatment in autoimmune diseases, diabetes mellitus type 1, and gastrointestinal diseases and disorders (miscellaneous).
AT-1001 is an orally administered octapeptide zonulin receptor antagonist that appears to exert its inhibitory effect on gliadin-induced tight junction disassembly by blocking putative zonulin receptors on the luminal surface of the small intestine.
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18561
Submission : 2005-08-05
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 73212-074
Start Marketing Date : 2023-05-29
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-096
Start Marketing Date : 2026-01-13
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 83589-132
Start Marketing Date : 2026-02-08
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
This study follows a Phase 2 clinical trial in 342 adult patients with celiac disease who had been on a gluten-free diet for at least 12 months, which concluded that INN-202 (larazotide) 0.5 mg significantly reduced symptoms of celiac disease.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 21, 2022
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : This study follows a Phase 2 clinical trial in 342 adult patients with celiac disease who had been on a gluten-free diet for at least 12 months, which concluded that INN-202 (larazotide) 0.5 mg significantly reduced symptoms of celiac disease.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
June 21, 2022
Details:
EBRIS and 9 Meters have entered into a material transfer agreement for drug supply sufficient to initiate and complete a Phase 1 study in Australia in 2021 to assess the safety and tolerability of larazotide when delivered directly to the lungs.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: European Biomedical Research Institute of Salerno
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 21, 2020
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : European Biomedical Research Institute of Salerno
Deal Size : Undisclosed
Deal Type : Collaboration
Details : EBRIS and 9 Meters have entered into a material transfer agreement for drug supply sufficient to initiate and complete a Phase 1 study in Australia in 2021 to assess the safety and tolerability of larazotide when delivered directly to the lungs.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
December 21, 2020
Details:
U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent for Use of Tight Junction Antagonists in the Treatment of Acute Lung Injury and Acute Respiratory Distress, relating to its proprietary investigational agent, larazotide.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 28, 2020
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent for Use of Tight Junction Antagonists in the Treatment of Acute Lung Injury and Acute Respiratory Distress, relating to its proprietary investigational agent, larazotide.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
July 28, 2020
Details:
The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 29, 2020
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
June 29, 2020
Details:
Innovative to change its name to 9 Meters Biopharma. 9 Biopharma meters to focus on delivering novel approach including the first and only long-acting GLP-1 agonist receptor for Short Bowel Syndrome.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: RDD Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger April 30, 2020
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : RDD Pharma
Deal Size : Undisclosed
Deal Type : Merger
Innovate Biopharmaceuticals and RDD Pharma Merge to Form 9 Meters Biopharma
Details : Innovative to change its name to 9 Meters Biopharma. 9 Biopharma meters to focus on delivering novel approach including the first and only long-acting GLP-1 agonist receptor for Short Bowel Syndrome.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
April 30, 2020
Details:
Larazotide is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Celiac Disease.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 26, 2018
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
Details : Larazotide is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Celiac Disease.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
June 26, 2018
Details:
GR181413A is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fabry Disease.
Lead Product(s): Migalastat,Larazotide Acetate
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 15, 2013
Lead Product(s) : Migalastat,Larazotide Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : GR181413A is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fabry Disease.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 15, 2013
Details:
AT1001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fabry Disease.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2012
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AT1001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fabry Disease.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
November 21, 2012
Details:
Larazotide Acetate is a Peptide drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Celiac Disease.
Lead Product(s): Larazotide Acetate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Peptide, Unconjugated
Sponsor: Teva Pharmaceutical Industries
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2011
Lead Product(s) : Larazotide Acetate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Larazotide Acetate is a Peptide drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Celiac Disease.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
July 18, 2011
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
ABOUT THIS PAGE
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PharmaCompass offers a list of Larazotide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Larazotide Acetate manufacturer or Larazotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Larazotide Acetate manufacturer or Larazotide Acetate supplier.
A Larazotide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Larazotide Acetate, including repackagers and relabelers. The FDA regulates Larazotide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Larazotide Acetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Larazotide Acetate supplier is an individual or a company that provides Larazotide Acetate active pharmaceutical ingredient (API) or Larazotide Acetate finished formulations upon request. The Larazotide Acetate suppliers may include Larazotide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Larazotide Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Larazotide Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Larazotide Acetate active pharmaceutical ingredient (API) in detail. Different forms of Larazotide Acetate DMFs exist exist since differing nations have different regulations, such as Larazotide Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Larazotide Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Larazotide Acetate USDMF includes data on Larazotide Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Larazotide Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Larazotide Acetate suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Larazotide Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Larazotide Acetate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Larazotide Acetate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Larazotide Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Larazotide Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Larazotide Acetate suppliers with NDC on PharmaCompass.
Larazotide Acetate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Larazotide Acetate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Larazotide Acetate GMP manufacturer or Larazotide Acetate GMP API supplier for your needs.
A Larazotide Acetate CoA (Certificate of Analysis) is a formal document that attests to Larazotide Acetate's compliance with Larazotide Acetate specifications and serves as a tool for batch-level quality control.
Larazotide Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Larazotide Acetate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Larazotide Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Larazotide Acetate EP), Larazotide Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Larazotide Acetate USP).
