Novel Approval Drug.....

1. CURRENTLY AUTHORIZED “DUAL DRUG AGONIST”(MOUNJARO)
for the treatment of DM-2
Bramhnapalli Kousalya*, N Nandini
4th Pharma D, Jagan's college of pharmacy, Nellore.
bramhnapallikousalya@gmail.com
INTRODUCTION:
 Tirzepatide is a Novel Dual Glucose dependent insulinotropic polypeptide(GIP) and Glucagon-like peptide-
1(GLP-1) receptor agonist.
 Tirzepatide was approved by the FDA on May 13,2022 for the treatment of Adults with Type-2 Diabetes, and
Lipid disorders, Obesity, Management of CVDs.
 Tirzepatide marketed by Lilly’s(LLY) as MOUNJARO.
 Dual GIP/GLP-1 agonists gained increasing attention as
new therapeutic agent for Glycemic and weight control
has they demonstrated better glucose control and weight
loss compared to selective GLP-1 receptor agonist in
preclinical and clinical trials
Abstract No: 20

2. MECHANISM OF ACTION:
 Tirzepatide is a multifunctional peptide based on the native GIP peptide sequence, modified to bind to both
GIP and GLP-1 receptors.
 Tirzepatide exert their effect by binding to specific receptors, activates and increases the level of intracellular
cAMP in pancreatic beta cells, thereby stimulating Insulin secretion, that is called Insulinotropic effects.
 Tirzepatide is a 39 Amino acid linear peptide and includes a C20 fatty diacid moiety.
 Invitro ,it has higher potency to native GIP and is less potent to native GLP-1.
 Tirzepatide has a mean half-life of 5 days (116.7hrs), enabling once-weekly dosing.

3. NEED OF THE STUDY :
 The purpose of this study is to determine the long-term safety and efficacy
of the study drug tirzepatide in combination with oral hypoglycemic
medication in participants with type-2 diabetes.
 To expose the Advanced treatment for the diabetic and obesity patient.
METERIALS :
 Each single dose pen contains a 0.5ml solution of 2.5mg, 5mg, 7.5mg, 10mg, 15mg of tirzepatide and the
following excipients: Sodium chloride(4.1mg), sodium phosphate dibasic heptahydrate(0.7mg) and water for
the injection.
METHODOLOGY:
 For the preparation of this presentation, we carried out a literature search using
SciFinder, PubMed, and Scopus.
 The KEY WORDS: ’Tirzepatide, and Diabetes’, Tirzepatide and Obesity, Novel
antidiabetics, were used to search the related articles.
 In total, 90 articles were found containing the true concepts ’Tirzepatide’ and
‘diabetics/obesity’ closely associated with one another.

4. STATISTICAL STUDIES:

5. RESULTS :
 Tirzepatide results as a potential blockbuster drug for type 2-DM,
as well as in weight reduction.
 EFFICACY: All Tirzepatide doses were noninferior to and also superior
to Semaglutide with respect to the mean reduction in glycated Hb
levels, patients in Tirzepatide groups also lost more weight than those
in the other groups.
 SAFETY: The percentage of patients reporting any adverse events was
similar across the groups, with Gastro intestinal events like Nausea,
Vomiting, Diarrhoea, etc…

6. DISCUSSION:
 The Twincretin era for treating patients with type-2 diabetes. It has begin with the US FDA approval for this
indication making it the 1st approved agent that works as dual agonist for the two principle human incretins.
 The FDA stated that tirzepatide represents an important advance in the treatment of type-2 diabetes, lipid
disorder, and obesity.
 The FDAs approved labelled includes all three doses of tirzepatide, that underwent testing in pivotal trials is
either. 5mg, 10mg, 15mg.
Dosage each delivered by Sc inj once a week.
SUMMARY:
 In summary, peptide molecule like semaglutide and tirzepatide have provided promising results for reducing HbAlc and
reducing body weight in human phase 1 and phase 2 clinical trials
 The US FDA approval for tirzepatide is believed to have provided a step forward in the management and treatment of T2D
and achieving weight loss, acting as a one-stop solution.

7. CONCLUSION:
• Type 2 Diabetes and obesity are deep rooted diseases that have no specific cure so far, but can be kept under
control by proper application of therapy and treatment, as well as incorporating lifestyle modifications.
• Tirzepatide has shown promising results in term of reducing HbAlc and reducing body weight in phase 1 and
phase 2 clinical trials.
• SURPASS-1 to 5 human clinical trials have given favourable results by comparision with similar moieties such
as semaglutide and delaglutide.
• The tiezepatide which has become a revolutionary agent for the management and treatment of T2D and
achieving weight loss.
• Patients compliance and dose adherence are also favoured, since it has advantage of once-a-week dose
Administration.

8. ACKNOWLEDGEMENT:
• We thank Seven Hills college of pharmacy(Autonomous) Tirupathi for providing the required facilities to
accomplish the review of the above entitted work.

9. REFERENCE:
1. https://www.researchgate.net/publication/347638655_The_Role_of_Tirzepatide_Dual_GIP_and_GLP
1_Receptor_Agonist_in_the_Management_of_Type_2_Diabetes_The_SURPASS_Clinical_Trails.
2. FDA Approves Tirzepatide, A Potential Blockbuster Drug for Type 2 Diabetes.
https://www.biochempeg.com/article/268.html.
3. Lilly Decides to Advance Tirzepatide for Obesity.
https://laptrinhx.com/news/lilly-decides-to-Advance-tirzepatide-for-obesity-4dnP5vw/amp/.
4. Tirzepatide, a new Era of Dual-Targeted Treatment for Diabetes and Obesity : A M
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9268041.
5. MEDSCAPE app .