Gemigliptin

Daewoong Pharmaceutical announces success in developing a new antidiabetic medication and its aims to enter the market in over 50 countries by 2030

Retrieved on: 
Tuesday, December 6, 2022
Ministry of Food and Drug Safety, Patient, Sale, Ministry, Roy Taylor (scientist), Drug development, Daewoong Pharmaceutical, Quality of life, Multimedia, Metformin, Safety, SGLT2, Pharmaceutical industry, Food, Gemigliptin

Until now, the development and approval of SGLT2 inhibitors have been carried out mainly by multinational pharmaceutical companies.

Key Points: 
  • Until now, the development and approval of SGLT2 inhibitors have been carried out mainly by multinational pharmaceutical companies.
  • Daewoong Pharmaceutical, South Korea's leading healthcare company, became the first domestically to succeed in developing a new antidiabetic drug in this class by obtaining a product license.
  • Daewoong Pharmaceutical plans to actively pursue the global market through this product.
  • At the same time, the company has developed a roadmap to enter the global market over 10 countries including China, Brazil and Saudi Arabia by 2025 and 50 countries by 2030.

Daewoong Pharmaceutical announces success in developing a new antidiabetic medication and its aims to enter the market in over 50 countries by 2030

Retrieved on: 
Tuesday, December 6, 2022
Ministry of Food and Drug Safety, Patient, Sale, Ministry, Roy Taylor (scientist), Drug development, Daewoong Pharmaceutical, Quality of life, Metformin, Safety, SGLT2, Pharmaceutical industry, Food, Gemigliptin

Until now, the development and approval of SGLT2 inhibitors have been carried out mainly by multinational pharmaceutical companies.

Key Points: 
  • Until now, the development and approval of SGLT2 inhibitors have been carried out mainly by multinational pharmaceutical companies.
  • Daewoong Pharmaceutical, South Korea's leading healthcare company, became the first domestically to succeed in developing a new antidiabetic drug in this class by obtaining a product license.
  • Daewoong Pharmaceutical plans to actively pursue the global market through this product.
  • At the same time, the company has developed a roadmap to enter the global market over 10 countries including China, Brazil and Saudi Arabia by 2025 and 50 countries by 2030.

ENYO Pharma Announces Positive Vonafexor (EYP001) Results for the LIVIFY Phase 2a Study in F2-F3 NASH Patients over 12 weeks

Retrieved on: 
Wednesday, July 28, 2021
Pharmaceutical, Health, Clinical trials, Other Health, Branches of biology, Chemistry, Chemical compounds, Magnesium, Magnesium in biology, Physiology, Plant physiology, Orphan drugs, Gemigliptin, Upadacitinib, Non-Alcoholic Steato-Hepatitis (NASH), Vonafexor (EYP001), ENYO Pharma, NON-ALCOHOLIC STEATO-HEPATITIS (NASH), VONAFEXOR (EYP001), ENYO PHARMA

In this Phase 2a trial, 96 patients with NASH were randomized 1:1:1 to receive oral, once-daily Vonafexor at 200 mg or 100 mg, or placebo.

Key Points: 
  • In this Phase 2a trial, 96 patients with NASH were randomized 1:1:1 to receive oral, once-daily Vonafexor at 200 mg or 100 mg, or placebo.
  • There were no significant differences in efficacy endpoints between the 100 mg and the 200 mg Vonafexor treatment groups.
  • 76 % of the patients receiving Vonafexor had improved kidney function as measured by eGFR over 12 weeks while 66 % of patients receiving placebo had deterioration of kidney function over the 12 week study period1).
  • The positive results seen on several key non-invasive tests at 12 weeks of dosing are highly encouraging and support advancement of this compound forward in NASH.

NewAmsterdam Pharma Reports Positive Results from Phase 2 Study of Oral Obicetrapib Demonstrating Over 50% LDL-Lowering as an Adjunct to High-Intensity Statins

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Cardiology, Medical specialties, Clinical medicine, Drugs, Organofluorides, Cardiology, TIMI, Statin, Low-density lipoprotein, Ezetimibe, Cholesteryl ester transfer protein, Bempedoic acid/ezetimibe, Gemigliptin

NAP is developing obicetrapib as an adjunct to maximally tolerated lipid-lowering therapy as a monotherapy and a fixed-dose combination with ezetimibe.

Key Points: 
  • NAP is developing obicetrapib as an adjunct to maximally tolerated lipid-lowering therapy as a monotherapy and a fixed-dose combination with ezetimibe.
  • Top-line results of the ROSE study show unprecedented effects of CETP inhibition on LDL-c reduction and HDL-c increase attributed to orally administered obicetrapib.
  • ROSE (NCT04753606) was designed as a placebo-controlled, double-blind, randomized, Phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
  • A total of 120 patients were randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period.

Metacrine Initiates Phase 2a Trial of MET642 for the Treatment of Patients with NASH

Retrieved on: 
Tuesday, March 9, 2021
Health sciences, Chemical compounds, Health, SGLT2 inhibitor, Organofluorides, Clinical trial, Obeticholic acid, Gemigliptin

The companys lead FXR clinical candidate, MET409, has successfully completed a 12-week trial in patients with NASH.

Key Points: 
  • The companys lead FXR clinical candidate, MET409, has successfully completed a 12-week trial in patients with NASH.
  • The Phase 2a clinical trial is a 16-week, randomized, placebo-controlled, multi-center trial evaluating the safety, tolerability and pharmacological activity (as measured by liver fat reduction) of MET642 (3 mg and 6 mg) vs placebo.
  • MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes.
  • MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being evaluated in a 16-week monotherapy trial in patients with NASH.

Metacrine Initiates Phase 2a Combination Trial of MET409 with Empagliflozin in Patients with Type 2 Diabetes and NASH

Retrieved on: 
Tuesday, January 5, 2021
Anti-diabetic drugs, SGLT2 inhibitor, Medical specialties, Empagliflozin, Organ systems, Drugs, Gemigliptin, Side effects of bicalutamide

In a proof-of-concept trial in patients with NASH and T2DM, empagliflozin (10 mg) achieved approximately 30% relative liver fat reduction after 20 weeks of treatment.

Key Points: 
  • In a proof-of-concept trial in patients with NASH and T2DM, empagliflozin (10 mg) achieved approximately 30% relative liver fat reduction after 20 weeks of treatment.
  • MET409 has already shown significant liver fat reductions and a differentiated tolerability profile as a monotherapy in patients with NASH.
  • MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes.
  • MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being advanced into a 16-week monotherapy trial in patients with NASH.

Hua Medicine Successfully Completes Its Registration Phase III Trials; Announces 52-Week Results for DAWN (HMM0302), Dorzagliatin's Phase III Combination with Metformin Trial

Retrieved on: 
Friday, December 18, 2020
Drugs, Clinical research, Chemical compounds, Biguanides, Guanidines, Metformin, Medicine, Placebo, Gemigliptin

The primary objective of the subsequent 28-week trial period was to evaluate and observe the safety profile of dorzagliatin.

Key Points: 
  • The primary objective of the subsequent 28-week trial period was to evaluate and observe the safety profile of dorzagliatin.
  • In July 2020, Hua Medicine announced the DAWN Trial had achieved its primary efficacy and safety endpoints over the initial 24-week double blinded period.
  • During the 28-week open-label period, patients initially receiving placebo + metformin (i.e., the placebo group) switched to receive dorzagliatin + metformin.
  • The Hua Medicine Portfolio Advisory Board ("PAB") is comprised of distinguished scientists and corporate management with extensive experience in the biopharmaceutical sector.

Bioniz Announces Positive Clinical Data of BNZ-1, First Anti-Cytokine Therapy to Demonstrate Efficacy in Treating Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Saturday, December 5, 2020
Branches of biology, Chemical compounds, Biology, Biomarkers, Biotechnology, Chemical pathology, Gemigliptin, Erdosteine

In addition to the positive efficacy data, we are extremely encouraged that the BNZ-1 treatment was well tolerated, which could support long-term treatment for these patients."

Key Points: 
  • In addition to the positive efficacy data, we are extremely encouraged that the BNZ-1 treatment was well tolerated, which could support long-term treatment for these patients."
  • There was a three-month treatment extension to further evaluate safety and clinical response at week 17.
  • BNZ-1 showed activity in all doses as determined by early signs of clinical efficacy and pharmacodynamic biomarkers.
  • The 2 mg/kg dose was selected based on pharmacokinetic/pharmacodynamic (PK/PD) relationship and clinical efficacy, and the cohort was expanded to 19 patients.

Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study

Retrieved on: 
Thursday, November 19, 2020
Health, Other Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Clinical research, Chemical compounds, Design of experiments, Medical research, Placebo-controlled study, Health sciences, Pyrimidines, Organofluorides, Gemigliptin, PBT2, Urovant Sciences, Sumitomo Dainippon Pharma Co., Ltd.

Urovant Sciences (Nasdaq: UROV) today announced positive efficacy and safety data from the vibegron EMPOWUR long term extension study with patient data over a total exposure of 52 weeks.

Key Points: 
  • Urovant Sciences (Nasdaq: UROV) today announced positive efficacy and safety data from the vibegron EMPOWUR long term extension study with patient data over a total exposure of 52 weeks.
  • These results are consistent with the results from the placebo-controlled EMPOWUR phase 3 study, with comparable safety and durable efficacy.
  • Urovant Sciences reported positive data from the vibegron 12-week, phase 3 pivotal EMPOWUR study and demonstrated favorable longer-term efficacy, safety, and tolerability in a 40-week extension study.
  • Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

Akero Presents Additional Positive Data from Phase 2a BALANCED Study Demonstrating Potential of Efruxifermin as a Foundational NASH Monotherapy

Retrieved on: 
Friday, November 13, 2020
Health, Diabetes, Research, Pharmaceutical, Science, Biotechnology, Clinical research, Design of experiments, Health sciences, Medical research, Health, Placebo-controlled study, Clinical trial, Gemigliptin, NASH, the BALANCED Study, Efruxifermin, Akero Therapeutics

Additional analysis of the BALANCED data showed substantial improvement in glycemic control for patients with both NASH and Type 2 diabetes, a group that comprises about half of all NASH patients.

Key Points: 
  • Additional analysis of the BALANCED data showed substantial improvement in glycemic control for patients with both NASH and Type 2 diabetes, a group that comprises about half of all NASH patients.
  • Akero plans to begin a Phase 2b/3 adaptive clinical trial in biopsy confirmed NASH patients in the first half of 2021.
  • The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH.
  • Efruxifermin (EFX), formerly known as AKR-001, is Akeros lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study.