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RHGAD-65

Alternative Names: rhgad-65, rhgad65, rhgad 65
Latest Update: 2025-01-20
Latest Update Note: Clinical Trial Update

Product Description

Recombinant human Glutamic Acid Decarboxylase (EC 4.1.1.15, 65kDa isoform, scientific abbreviation is ÒrhGAD65Ó) expressed in baculoviral infection of Spodoptera frugiperda cells (Sourced from: https://www.diamyd.com/docs/prodfiles/rhGAD65_DIAMYD_PDS_2016-06-22.pdf)

Mechanisms of Action: Vaccine

Novel Mechanism: No

Modality: Vaccine

Route of Administration: Injection

FDA Designation: Fast Track - *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Diamyd
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for RHGAD-65

Countries in Clinic: Czech Republic, Estonia, Germany, Hungary, Netherlands, Poland, Spain, Sweden, United States

Active Clinical Trial Count: 2

Highest Development Phases

Phase 3: Type 1 Diabetes

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
DIAGNODE-3

P3

Recruiting

Type 1 Diabetes

2027-12-01

DiaPrecise

P2

Active, not recruiting

Type 1 Diabetes

2024-12-14

Recent News Events

Date

Type

Title

01/13/2025

News Article

 Diamyd Medical updates U.S. market potential for Diamyd®

01/10/2025

News Article

 Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting

12/13/2024

News Article

 Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process

09/09/2024

News Article

 Diamyd Medical to pursue accelerated approval pathway for Type 1 Diabetes precision medicine

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