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1. Glycyl-l-2-methylprolyl-l-glutamic Acid
1. 853400-76-7
2. Nnz-2566
3. Trofinetide [inn]
4. Trofinetide [usan]
5. Z2me8f52ql
6. L-glutamic Acid, Glycyl-2-methyl-l-prolyl-
7. Acp-2566
8. ((s)-1-glycyl-2-methylpyrrolidine-2-carbonyl)-l-glutamic Acid
9. Unii-z2me8f52ql
10. Nnz 2566
11. Glycyl-l-2-methylprolyl-l-glutamic Acid
12. Glycyl-2-methyl-l-prolyl-l-glutamic Acid
13. Trofinetide(nnz2566)
14. Trofinetide [who-dd]
15. Chembl197084
16. Schembl1170014
17. Gly-2-methyl-l-pro-l-glu-oh
18. Dtxsid101336041
19. Who 10076
20. Cs-8154
21. Db06045
22. Hy-16757
23. A16972
24. Q27294917
25. (2s)-2-[[(2s)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino]pentanedioic Acid
| Molecular Weight | 315.32 g/mol |
|---|---|
| Molecular Formula | C13H21N3O6 |
| XLogP3 | -3.9 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 7 |
| Exact Mass | 315.14303540 g/mol |
| Monoisotopic Mass | 315.14303540 g/mol |
| Topological Polar Surface Area | 150 Ų |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 480 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| 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 traumatic brain injuries.
NNZ-2566 is shown to have multi-faceted action to significantly reduce both inflammation and apoptosis (cell death), protecting the neurons and their surrounding infrastructure.
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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:
Acadia is selling its rare pediatric disease priority review voucher for Daybue (trofinetide) is a prescription oral therapy for the treatment of Rett syndrome.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: Daybue
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Undisclosed
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Divestment November 05, 2024
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $150.0 million
Deal Type : Divestment
Acadia Sells Priority Review Voucher for $150M
Details : Acadia is selling its rare pediatric disease priority review voucher for Daybue (trofinetide) is a prescription oral therapy for the treatment of Rett syndrome.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Undisclosed
November 05, 2024
Details:
Daybue (trofinetide) is a weak inhibitor of CYP3A4, which is indicated for the treatment of Rett syndrome, a rare neurodevelopmental disorder.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: Daybue
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2024
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Acadia Pharma Announces Health Canada Approval of DAYBUE™ For Rett Syndrome
Details : Daybue (trofinetide) is a weak inhibitor of CYP3A4, which is indicated for the treatment of Rett syndrome, a rare neurodevelopmental disorder.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 16, 2024
Details:
Daybue (trofinetide) is a weak inhibitor of CYP3A4, which is indicated for the treatment of Rett syndrome, a rare neurodevelopmental disorder. It is already approved by FDA for the same indication.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: Daybue
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2024
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Acadia Submits Trofinetide NDA For Rett Syndrome, Accepted For Filing And Review
Details : Daybue (trofinetide) is a weak inhibitor of CYP3A4, which is indicated for the treatment of Rett syndrome, a rare neurodevelopmental disorder. It is already approved by FDA for the same indication.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
April 22, 2024
Details:
Daybue (trofinetide) is a CYP3A4 inhibitor which helps to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: Daybue
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2023
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Acadia Pharmaceuticals Announces DAYBUE™ (trofinetide) is Now Available for the Treatment of Ret...
Details : Daybue (trofinetide) is a CYP3A4 inhibitor which helps to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
April 17, 2023
Details:
Daybue (trofinetide) is a CYP3A4 inhibitor which helps to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: Daybue
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Acadia Pharmaceuticals Announces U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of...
Details : Daybue (trofinetide) is a CYP3A4 inhibitor which helps to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 10, 2023
Details:
The NDA is supported by results from the pivotal Phase 3 Lavender study evaluating the efficacy and safety of NNZ-2566 (trofinetide) versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: NNZ-2566
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The NDA is supported by results from the pivotal Phase 3 Lavender study evaluating the efficacy and safety of NNZ-2566 (trofinetide) versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.
Brand Name : NNZ-2566
Molecule Type : Peptide
Upfront Cash : Not Applicable
September 12, 2022
Details:
NNZ-2566 (trofinetide) is an investigational drug, is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: NNZ-2566
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NNZ-2566 (trofinetide) is an investigational drug, is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
Brand Name : NNZ-2566
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 18, 2022
Details:
Trofinetide is an investigational novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
Lead Product(s): Trofinetide
Therapeutic Area: Genetic Disease Brand Name: Trofinetide
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Trofinetide is an investigational novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
Brand Name : Trofinetide
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2022
Details:
Upon FDA approval of a product with RPD designation, ACADIA may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product.
Lead Product(s): Trofinetide
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2020
Lead Product(s) : Trofinetide
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation
Details : Upon FDA approval of a product with RPD designation, ACADIA may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 03, 2020
Details:
Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher.
Lead Product(s): Trofinetide
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2020
Lead Product(s) : Trofinetide
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ACADIA announce Rare Pediatric Disease Designation for Trofinetide
Details : Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 03, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : RX
Registration Country : USA
Brand Name : DAYBUE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 200MG/ML
Packaging :
Approval Date : 2023-03-10
Application Number : 217026
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code :
Brand Name : DAYBUE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 200MG/ML
Approval Date : 2023-03-10
Application Number : 217026
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2032-01-27
US Patent Number : 9212204
Drug Substance Claim :
Drug Product Claim :
Application Number : 217026
Patent Use Code : U-3556
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-01-27
Patent Expiration Date : 2040-08-03
US Patent Number : 11370755
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217026
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-08-03
Patent Expiration Date : 2042-07-12
US Patent Number : 11827600
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217026
Patent Use Code : U-3556
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2042-07-12
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]US Exclusivities
Exclusivity Code : ODE-425
Exclusivity Expiration Date : 2030-03-10
Application Number : 217026
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-03-10
Application Number : 217026
Product Number : 1
Exclusivity Details :
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