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Details:
Saxagliptin and Metformin Hydrochloride extended-release tablets is a dipeptidyl peptidase-4 (DPP4) inhibitor and biguanide combination product indicated for adults with type 2 diabetes mellitus.
Lead Product(s): Saxagliptin,Metformin
Therapeutic Area: Endocrinology Product Name: Kombiglyze-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2023
Details:
Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.
Lead Product(s): Vildagliptin,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Jalra Trio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2023
Details:
Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.
Lead Product(s): Teneligliptin,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Zita DM
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Details:
RJx-01, a novel combination drug comprising galantamine and metformin, demonstrated positive results in 42 elderly male subjects with disuse-induced muscle atrophy.
Lead Product(s): Galanthamine,Metformin
Therapeutic Area: Musculoskeletal Product Name: RJx-01
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2023
Details:
Sitagliptin, Pioglitazone & Metformin are combined for the treatment of diabetes. Metformin, coupled with the functional and corrective influence of pioglitazone on beta-cell and metabolic syndrome and the stability of Sitagliptin, make an effective solution for diabetes.
Lead Product(s): Sitagliptin Phosphate,Pioglitazone,Metformin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2023
Details:
Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablet is a sodium-glucose cotransporter 2 inhibitor a once-daily fixed-dose combination, has been approved for type-2 diabetes.
Lead Product(s): Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Xigduo XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
Details:
Canagliflozin inhibits SGLT2 which reduces reabsorption of filtered glucose thereby increases urinary glucose excretion. Metformin decreases hepatic glucose production, intestinal absorption of glucose and improves insulin sensitivity.
Lead Product(s): Canagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Canagliflozin/Metformin Hydrochloride-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2023
Details:
DWP16001 (enavogliflozin) is a new diabetes drug in the SGLT-2 inhibitor class. The two combination trials, Enavogliflozin-Metformin and Enavogliflozin-Metformin-Gemigliptin combination, demonstrated non-inferiority in HbAc1 change compared to dapagliflozin 10 mg.
Lead Product(s): Enavogliflozin,Metformin,Gemigliptin
Therapeutic Area: Endocrinology Product Name: DWP16001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2022
Details:
Previous trials with ANJ900 demonstrated clinically meaningful glucose lowering with only one-third the plasma concentrations observed with currently marketed formulations of metformin.
Lead Product(s): Metformin
Therapeutic Area: Endocrinology Product Name: ANJ900
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Population Health
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 19, 2022
Details:
GMRx4 is being developed to provide a synergistic effect from three best-in-class type 2 diabetes treatments – metformin, dapagliflozin and sitagliptin – and, in an ultra-low-dose, single pill formulation, aims to be a more effective, simpler and safer treatment regimen.
Lead Product(s): Metformin,Dapagliflozin,Sitagliptin Phosphate
Therapeutic Area: Endocrinology Product Name: GMRx4
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CUREator
Deal Size: $1.0 million Upfront Cash: Undisclosed
Deal Type: Financing July 20, 2022
Details:
ANJ900 (Metformin) is a gut-targeted formulation designed to lower glucose with reduced systemic exposure of metformin, so that patients who cannot take currently available formulations of metformin may achieve better glucose control.
Lead Product(s): Metformin
Therapeutic Area: Endocrinology Product Name: ANJ900
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
In a European worksharing procedure (WSP), Glucophage was approved as the first oral anti-diabetic medication to be used safely from conception to birth and the approval is, on the basis of Merck’s own safety cohort study CLUE1 and a large body of published evidence.
Lead Product(s): Metformin
Therapeutic Area: Endocrinology Product Name: Glucophage
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2022
Details:
Enavogliflozin is an SGLT-2 inhibitor for diabetes in development by Daewoong for the first time in South Korea. The safety of Enavogliflozin has been proven through three sequential clinical trials of monotherapy, metformin combination, and Metformin-Gemigliptin combination.
Lead Product(s): Enavogliflozin,Metformin,Gemigliptin
Therapeutic Area: Endocrinology Product Name: DWP16001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
Glenmark is the first company in the world to launch Remogliflozin + Vildagliptin + Metformin fixed dose combination (FDC) and India is the first country to get access to this FDC drug.
Lead Product(s): Remogliflozin Etabonate,Vildagliptin,Metformin
Therapeutic Area: Endocrinology Product Name: Remozen MV
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
Anji Pharma has initiated a pivotal trial of ANJ900 (delayed-release metformin) in patients with Type 2 diabetes (T2D), including those with varying stages of renal disease.
Lead Product(s): Metformin
Therapeutic Area: Endocrinology Product Name: ANJ900
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2021
Details:
After termination of the agreement, AstraZeneca India will continue to independently market Dapagliflozin, the combinations of Dapagliflozin and Metformin as well as Dapagliflozin and Saxagliptin in India under the brand names Forxiga, Xigduo and Qtern respectively.
Lead Product(s): Dapagliflozin Propanediol Monohydrate,Metformin
Therapeutic Area: Endocrinology Product Name: Xigduo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination May 28, 2021
Details:
Granules India has been granted final FDA approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Health US LLC (Bausch).
Lead Product(s): Metformin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
Lupin has received tentative approval for its Empagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, from the U.S FDA, to market a generic equivalent of Synjardy® XR Tablets.
Lead Product(s): Empagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2021
Details:
The trial will test whether a common diabetes drug called metformin can boost cognitive function and enhance recovery in childhood brain cancer survivors.
Lead Product(s): Metformin
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Canadian Institutes of Health Research
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
The topline results of a phase 2 clinical trial of CS02 showed significantly decreases of glycated hemoglobin (HbA1c) in treated patients as compared to placebo group by 0.45%.
Lead Product(s): CS02,Metformin
Therapeutic Area: Endocrinology Product Name: CS02
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2020
Details:
All subjects are treated with metformin (Glucophage) at 1500mg/day as basic therapy throughout the entire 52-week treatment period. Study met the primary efficacy and safety endpoints in the double-blinded placebo-controlled and randomized 24-week trial.
Lead Product(s): Dorzagliatin,Metformin
Therapeutic Area: Endocrinology Product Name: HMS5552
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
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