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1. (1r-(2-endo,3-exo))-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo(3,2,1)octane-2-hydroxy-1,2,3-propanetricarboxylate
1. 195875-84-4
2. Ns-2330
3. Tesofensine [inn]
4. Ns 2330
5. Blh9ukx9v1
6. (1r,2r,3s,5s)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo[3.2.1]octane
7. (1r,2r,3s,5s)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo(3.2.1)octane
8. Unii-blh9ukx9v1
9. Tesofensine [mi]
10. Tesofensine [mart.]
11. Schembl37509
12. Tesofensine [who-dd]
13. Chembl3989690
14. Dtxsid70905114
15. Zinc3953158
16. Ns2330
17. Db06156
18. Hy-14472
19. Cs-0003378
20. J-012675
21. Q7705544
22. (1r,2r,3s)-2-ethoxymethyl-3-(3,4-dichlorophenyl)tropane
23. (1r, 2r, 3s)-2-ethoxymethyl-3-(3,4-dichlorophenyl)tropane
24. (1r-(2-endo,3-exo))-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo(3,2,1)octane-2-hydroxy-1,2,3-propanetricarboxylate
25. 8-azabicyclo(3.2.1)octane, 3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-, (1r-(2-endo,3-exo))-
Molecular Weight | 328.3 g/mol |
---|---|
Molecular Formula | C17H23Cl2NO |
XLogP3 | 4.5 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 4 |
Exact Mass | 327.1156697 g/mol |
Monoisotopic Mass | 327.1156697 g/mol |
Topological Polar Surface Area | 12.5 Ų |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 354 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
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 alzheimer's disease, parkinson's disease, and obesity.
Tesofensine is a Serotonin-norepinephrine-dopamine-reuptake-inhibitor (SNDRI). SNDRIs are a class of psychoactive antidepressants. They act upon neurotransmitters in the brain, namely, serotonin, norepinephrine and dopamine. These three biogenic monoamines are associated with depression and increasing the availability in the brain is one method used to treat the condition.
NDC Package Code : 73212-039
Start Marketing Date : 2022-01-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-207
Start Marketing Date : 2022-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12651-121
Start Marketing Date : 2021-01-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 73212-039
Start Marketing Date : 2022-01-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12651-121
Start Marketing Date : 2021-01-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-207
Start Marketing Date : 2022-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Details:
Tesomet (tesofensine), is a novel, proprietary molecule, and investigational fixed-dose combination therapy of, a triple monoamine reuptake inhibitor and metoprolol (a beta-1 selective blocker).
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 23, 2022
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona's Clinical Trial in Hypothalamic Obesity Published in Scientific Journal
Details : Tesomet (tesofensine), is a novel, proprietary molecule, and investigational fixed-dose combination therapy of, a triple monoamine reuptake inhibitor and metoprolol (a beta-1 selective blocker).
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 23, 2022
Details:
Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 20, 2022
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona Provides Update on Ongoing Review of Tesofensine in Mexico
Details : Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 20, 2022
Details:
Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of the study.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 28, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi Syndrome
Details : Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of t...
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 28, 2021
Details:
The initiation of this Phase 2b clinical trial of tesomet represents the culmination of the significant work and primary endpoint of study is the percentage change in body weight from baseline to week 36.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 17, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona Initiates Phase 2b Clinical Trial of Tesomet for Hypothalamic Obesity
Details : The initiation of this Phase 2b clinical trial of tesomet represents the culmination of the significant work and primary endpoint of study is the percentage change in body weight from baseline to week 36.
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 17, 2021
Details:
Tesomet capsules contain two active ingredients as microspheres of fixed-dose combination therapy of tesofensine (triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker) used for treatment for hypothalamic obesity and Prader-Willi syndrome.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Brand Name: Tesomet
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona Completes Submission of Manufacturing Data for Tesomet Capsules To U.S. FDA
Details : Tesomet capsules contain two active ingredients as microspheres of fixed-dose combination therapy of tesofensine (triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker) used for treatment for hypothalamic obesity and Prader-Will...
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 18, 2021
Details:
Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 26, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona Gets U.S. FDA Orphan Drug Designation for Tesomet in Hypothalamic Obesity
Details : Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control.
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 26, 2021
Details:
The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 21, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 21, 2021
Details:
Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first half of this year.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Foundation for Prader-Willi Research
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 19, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Foundation for Prader-Willi Research
Deal Size : Undisclosed
Deal Type : Partnership
Details : Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first ...
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 19, 2021
Details:
Saniona is preparing to start a Phase 2b study of Tesomet in Prader-Willi Syndrome this year. In a Phase 2a trial, adults patients receiving Tesomet achieved a significant reduction in hyperphagia and a clinically meaningful reduction in body weight at a dose of 0.5 mg/day.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Brand Name: Tesomet
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 03, 2021
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome
Details : Saniona is preparing to start a Phase 2b study of Tesomet in Prader-Willi Syndrome this year. In a Phase 2a trial, adults patients receiving Tesomet achieved a significant reduction in hyperphagia and a clinically meaningful reduction in body weight at a...
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 03, 2021
Details:
Tesomet was well-tolerated in hypothalamic obesity patients throughout the duration of the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. All patients who entered the OLE study completed it.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 23, 2020
Lead Product(s) : Tesofensine,Metoprolol Tartrate
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tesomet was well-tolerated in hypothalamic obesity patients throughout the duration of the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. All patients who entered the OLE study completed it.
Product Name : Tesomet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 23, 2020
28 Dec 2021
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2021/12/28/2358524/0/en/Saniona-Initiates-Phase-2b-Clinical-Trial-of-Tesomet-for-Prader-Willi-Syndrome.html
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Reply
26 Feb 2019
ABOUT THIS PAGE
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PharmaCompass offers a list of Tesofensine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tesofensine manufacturer or Tesofensine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tesofensine manufacturer or Tesofensine supplier.
PharmaCompass also assists you with knowing the Tesofensine API Price utilized in the formulation of products. Tesofensine API Price is not always fixed or binding as the Tesofensine Price is obtained through a variety of data sources. The Tesofensine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tesofensine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tesofensine, including repackagers and relabelers. The FDA regulates Tesofensine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tesofensine 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 Tesofensine supplier is an individual or a company that provides Tesofensine active pharmaceutical ingredient (API) or Tesofensine finished formulations upon request. The Tesofensine suppliers may include Tesofensine API manufacturers, exporters, distributors and traders.
click here to find a list of Tesofensine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tesofensine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tesofensine 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 Tesofensine 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 Tesofensine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tesofensine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tesofensine suppliers with NDC on PharmaCompass.
Tesofensine 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 Tesofensine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Tesofensine GMP manufacturer or Tesofensine GMP API supplier for your needs.
A Tesofensine CoA (Certificate of Analysis) is a formal document that attests to Tesofensine's compliance with Tesofensine specifications and serves as a tool for batch-level quality control.
Tesofensine CoA mostly includes findings from lab analyses of a specific batch. For each Tesofensine 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.
Tesofensine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tesofensine EP), Tesofensine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tesofensine USP).