Delving into the Latest Updates on Pemafibrate/Tofogliflozin Hydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

Mechanism

PPARα agonists(Peroxisome proliferator-activated receptor α agonists), SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Kowa Research Institute, Inc.

Active Organization

Kowa Co., Ltd.Kowa Research Institute, Inc.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure

Molecular FormulaC22H28O7

InChIKeyZXOCGDDVNPDRIW-NHFZGCSJSA-N

CAS Registry1201913-82-7

View All Structures (2)

A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001

The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.

Start Date24 Feb 2023

Sponsor / Collaborator

Kowa Research Institute, Inc.

NCT04183478 / Unknown statusPhase 2/3IIT

A Randomized, Double Blinded, Parallel-controlled, Multi-center Phase II/III Study to Compare the Best Support Care (BSC) Plus K-001 Versus BSC Plus Placebo for the Third-line and Later Treatment of Patients With Advanced Pancreatic Cancer

No Standard therapy has been approved for third-line therapy of advanced pancreatic cancer. K001 is peptidoglycan prepared from the marine microorganism, with an anti-tumor activity. Previously, the phase I study of K001 has shown that K001 was safety and had some effectiveness for pancreatic patients. Now, we would like to lunch a randomized, blinded, parallel-controlled, multi-center phase II/III study to compare the best support care (BSC) plus K-001 versus BSC plus placebo for the third-line and later treatment of patients with advanced pancreatic cancer.

Start Date26 Sep 2017

Sponsor / Collaborator