DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....
Dasiglucagon
Treatment of Hypoglycemia in Type 1 and Type 2 Diabetes Patients
| Formula | C152H222N38O50 |
|---|---|
| CAS | 1544300-84-6 |
| Mol weight | 3381.6137 |
FDA APPROVED, 2021/3/22, Zegalogue
Zealand Pharma A/S
UNIIAD4J2O47FQ
HypoPal rescue pen
(4S)-4-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-4-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-2-methylpropanoyl]amino]propanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-carboxy-1-[[(2S)-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxohexan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-5-oxopentanoic acid
. [16-(2-methylalanine)(S>X),17-L-alanine(R>A),20-L-α-glutamyl(Q>E),21-L-αglutamyl(D>E),24-L-lysyl(Q>K),27-L-α-glutamyl(M>E),28-L-serine(N>S)]human glucagon
L-Threonine, L-histidyl-L-seryl-L-glutaminylglycyl-L-threonyl-L- phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L- lysyl-L-tyrosyl-L-leucyl-L-α-aspartyl-2-methylalanyl-L-alanyl-L- arginyl-L-alanyl-L-α-glutamyl-L-α-glutamyl-L-phenylalanyl-L- valyl-L-lysyl-L-tryptophyl-L-leucyl-L-α-glutamyl-L-seryl
L-Threonine, L-histidyl-L-seryl-L-glutaminylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-alpha-aspartyl-L-tyrosyl-L-seryl-L-lysyl-L-tyrosyl-L-leucyl-L-alpha-aspartyl-2-methylalanyl-L-alanyl-L-arginyl-L-alanyl-L-alpha-glutamyl-L-alphaC152 H222 N38 O50L-Threonine, L-histidyl-L-seryl-L-glutaminylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L-lysyl-L-tyrosyl-L-leucyl-L-α-aspartyl-2-methylalanyl-L-alanyl-L-arginyl-L-alanyl-L-α-glutamyl-L-α-glutamyl-L-phenylalanyl-L-valyl-L-lysyl-L-tryptophyl-L-leucyl-L-α-glutamyl-L-seryl-Molecular Weight3381.61
Other Names
- L-Histidyl-L-seryl-L-glutaminylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L-lysyl-L-tyrosyl-L-leucyl-L-α-aspartyl-2-methylalanyl-L-alanyl-L-arginyl-L-alanyl-L-α-glutamyl-L-α-glutamyl-L-phenylalanyl-L-valyl-L-lysyl-L-tryptophyl-L-leucyl-L-α-glutamyl-L-seryl-L-threonine
- Developer Beta Bionics; Zealand Pharma
- ClassAntihyperglycaemics; Antihypoglycaemics; Peptides
- Mechanism of ActionGlucagon receptor agonists
- Orphan Drug StatusYes – Hypoglycaemia; Congenital hyperinsulinism
- RegisteredHypoglycaemia
- Phase IIICongenital hyperinsulinism
- Phase II/IIIType 1 diabetes mellitus
- 22 Mar 2021Registered for Hypoglycaemia (In children, In adolescents, In adults, In the elderly) in USA (SC) – First global approval
- 22 Mar 2021Zealand Pharma anticipates the launch of dasiglucagon in USA (SC, Injection) in June 2021
- 22 Mar 2021Pooled efficacy and safety data from three phase III trials in Hypoglycaemia released by Zealand Pharma
NEW DRUG APPROVALS
one time
$10.00
PATENTS
WO 2014016300
US 20150210744
PAPER
Pharmaceutical Research (2018), 35(12), 1-13
Dasiglucagon, sold under the brand name Zegalogue, is a medication used to treat severe hypoglycemia in people with diabetes.[1]
The most common side effects include nausea, vomiting, headache, diarrhea, and injection site pain.[1]
Dasiglucagon was approved for medical use in the United States in March 2021.[1][2][3] It was designated an orphan drug in August 2017.[4]
Dasiglucagon is under investigation in clinical trial NCT03735225 (Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration).
Medical uses
Dasiglucagon is indicated for the treatment of severe hypoglycemia in people aged six years of age and older with diabetes.[1][2]
Contraindications
Dasiglucagon is contraindicated in people with pheochromocytoma or insulinoma.[1]
References
- ^ Jump up to:a b c d e f https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf
- ^ Jump up to:a b “Dasiglucagon: FDA-Approved Drugs”. U.S. Food and Drug Administration (FDA). Retrieved 22 March 2021.
- ^ “Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes” (Press release). Zealand Pharma. 22 March 2021. Retrieved 22 March 2021 – via GlobeNewswire.
- ^ “Dasiglucagon Orphan Drug Designations and Approvals”. U.S. Food and Drug Administration (FDA). 10 August 2017. Retrieved 22 March 2021.
External links
- “Dasiglucagon”. Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT03378635 for “A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects” at ClinicalTrials.gov
- Clinical trial number NCT03688711 for “Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM” at ClinicalTrials.gov
- Clinical trial number NCT03667053 for “Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children” at ClinicalTrials.gov
| Clinical data | |
|---|---|
| Trade names | Zegalogue |
| AHFS/Drugs.com | Zegalogue |
| License data | US DailyMed: Dasiglucagon |
| Routes of administration | Subcutaneous |
| Drug class | Glucagon receptor agonist |
| ATC code | None |
| Legal status | |
| Legal status | US: ℞-only [1] |
| Identifiers | |
| showIUPAC name | |
| CAS Number | 1544300-84-6 |
| PubChem CID | 126961379 |
| DrugBank | DB15226 |
| UNII | AD4J2O47FQ |
| KEGG | D11359 |
| Chemical and physical data | |
| Formula | C152H222N38O50 |
| Molar mass | 3381.664 g·mol−1 |
| 3D model (JSmol) | Interactive image |
///////////Dasiglucagon, FDA 2021, APPROVALS 2021, Zegalogue, ダシグルカゴン, ZP 4207, ZP-GA-1, Hypoglycemia, Type 1, Type 2 , Diabetes Patients, Zealand Pharma A/S, Orphan Drug Status, Hypoglycaemia, Congenital hyperinsulinism, HypoPal rescue pen, DIABETES
#Dasiglucagon, #FDA 2021, #APPROVALS 2021, #Zegalogue, #ダシグルカゴン, #ZP 4207, ZP-GA-1, #Hypoglycemia, #Type 1, #Type 2 , #Diabetes Patients, #Zealand Pharma A/S, #Orphan Drug Status, #Hypoglycaemia, #Congenital hyperinsulinism, #HypoPal rescue pen, #DIABETESSMILES
- C[C@H]([C@@H](C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CC2=CC=C(C=C2)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC3=CC=C(C=C3)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)NC(C)(C)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC4=CC=CC=C4)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC5=CNC6=CC=CC=C65)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)O)C(=O)O)NC(=O)CNC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CO)NC(=O)[C@H](CC7=CNC=N7)N)O
New Drug Approvals 
#Dasiglucagon, #FDA 2021, #APPROVALS 2021, #Zegalogue, #ダシグルカゴン, #ZP 4207, ZP-GA-1, #Hypoglycemia, #Type 1, #Type 2 , #Diabetes Patients, #Zealand Pharma A/S, #Orphan Drug Status, #Hypoglycaemia, #Congenital hyperinsulinism, #HypoPal rescue pen, #DIABETES