Delving into the Latest Updates on ENN-0403 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ENN 0403, ENN-0403, ENN0403

Target-

Action-

Mechanism-

Therapeutic Areas

Cardiovascular DiseasesEndocrinology and Metabolic DiseaseEye Diseases+ [3]

Active Indication

Diabetic macular oedemaAcute Kidney InjurySepsis

Inactive Indication

Nonalcoholic Steatohepatitis

Originator Organization

EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,

Active Organization

EnnovaBio Australia Pharmaceuticals Pty LtdEnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,

Shanghai Ennovabio Pharmaceuticals Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.

Start Date12 Dec 2024

Sponsor / Collaborator

EnnovaBio Australia Pharmaceuticals Pty Ltd

NCT06632613

/ RecruitingPhase 2

A Phase 2 Clinical Study Evaluating the Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery Requiring Cardiopulmonary Bypass

The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.

Start Date05 Nov 2024

Sponsor / Collaborator

EnnovaBio Australia Pharmaceuticals Pty Ltd

ChiCTR2500098233

/ RecruitingPhase 2IIT

A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects With Diabetic Macular Edema (DME)

Start Date08 Oct 2024

Sponsor / Collaborator

Shanghai Ennovabio Pharmaceuticals Co. Ltd.

100 Clinical Results associated with ENN-0403

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100 Translational Medicine associated with ENN-0403

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100 Patents (Medical) associated with ENN-0403

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100 Deals associated with ENN-0403

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	China	EnnovaBio Australia Pharmaceuticals Pty Ltd	12 Dec 2024
Diabetic macular oedema	Phase 2	China	Shanghai Ennovabio Pharmaceuticals Co. Ltd.	12 Dec 2024
Acute Kidney Injury	Phase 2	China	EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,	05 Nov 2024
Acute Kidney Injury	Phase 2	China	EnnovaBio Australia Pharmaceuticals Pty Ltd	05 Nov 2024
Nonalcoholic Steatohepatitis	Phase 1	China	EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,	11 Feb 2022
Sepsis	IND Approval	China	EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,	11 Mar 2024