Drugs / rhGAD65
rhGAD65
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT04262479 | Mar 2020 → May 2022 | latent autoimmune diabetes in adults | Norwegian University of Science and Technology | Completed | No outcome recorded |
| Phase 2 | NCT02464033 | May 2015 → Feb 2019 | type 1 diabetes mellitus | Johnny Ludvigsson | Completed | No outcome recorded |
| Phase 2 | NCT00529399 | Feb 2009 → May 2012 | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Missed primary |
| Phase 2 | NCT00435981 | Jan 2005 → Oct 2007 | type 1 diabetes mellitus | Diamyd Therapeutics AB | Completed | Missed primary |
| Phase 2 | NCT00456027 | Dec 2004 → Mar 2008 | latent autoimmune diabetes in adults | Diamyd Therapeutics AB | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT05018585 | May 2022 → Dec 2027 expected | type 1 diabetes mellitus | Diamyd Medical AB | Active not recruiting | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT03345004 Comparator | Dec 2017 → Jul 2020 | type 1 diabetes mellitus | Diamyd Medical AB | Completed | No outcome recorded |
| Phase 3 | NCT00751842 Comparator | Sep 2008 → Mar 2012 | type 1 diabetes mellitus | Diamyd Therapeutics AB | Terminated | No outcome recorded |
| Phase 3 | NCT00723411 Comparator | Jul 2008 → May 2011 | type 1 diabetes mellitus | Diamyd Therapeutics AB | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Diamyd Therapeutics AB | Results Now published: Retogatein from Diamyd Medical delays the need for insulin by more than five years in the randomized, placebo-controlled diabetes prevention – Immune Tolerance Trial diamyd.com ↗
While we do not yet prevent type 1 diabetes, the published data show that retogatein delayed the need for insulin by 5.6 years in the treatment responder group. |
| 2026-09-24 | Diamyd Therapeutics AB | Results Diamyd’s retogatein delays insulin requiring Type-1 Diabetes for more than 5 years diamyd.com ↗
Long-term follow-up of the randomized, placebo-controlled DiAPREV-IT study, now in press in Diabetologia, shows that two subcutaneous injections of retogatein (GAD-alum) significantly delayed Stage 3 Type 1 Diabetes by over five years in a genetically defined subgroup of children. |
| 2026-07-27 | Diamyd Therapeutics AB | Results Diamyd Medical Provides Update on Learnings from DIAGNODE-3 Interim Analysis diamyd.com ↗
The Company is closing DIAGNODE-3 for futility in accordance with the trial’s pre-specified decision framework. |
| 2026-04-10 | Diamyd Therapeutics AB | Results Diamyd Medical discontinues DIAGNODE-3 following evaluation confirming futility; initiates strategic review diamyd.com ↗
Following the previously reported interim analysis and subsequent evaluation of the interim results, including independent external statistical validation, the Company has concluded that the interim results meet the pre-specified futility criteria and do not support continuation. |
| 2026-03-29 | Diamyd Therapeutics AB | Results Diamyd Medical updates on the interim efficacy analysis of Phase 3 DIAGNODE-3 trial diamyd.com ↗
Based on the interim dataset, no treatment effect on C-peptide was observed, neither in the overall population nor in pre-specified subgroups, including the previously identified potential super responder group. |
| 2026-03-27 | Diamyd Therapeutics AB | Results Diamyd Medical reports negative interim results of Phase 3 DIAGNODE-3 trial diamyd.com ↗
The interim analysis that included 174 out of 321 study participants did not demonstrate statistical significance on the primary endpoint at this timepoint. |
All press releases naming this drug 43 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhGAD65 | “GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator.” NCT00529399 ↗8“Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)” NCT03345004 ↗ “Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)” NCT02464033 ↗ |
| Known as | Diamyd | “This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously...” NCT00435981 ↗1“The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients...” NCT00751842 ↗ |
| Known as | GAD-Alum | “BACKGROUND: This study aimed to analyse data from two different studies (phase II and phase III) regarding the safety and efficacy of treatment with alum formulated glutamic...” PMID 24302596 ↗ Jul 20141“GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator.” NCT00529399 ↗ |
| Known as | recombinant human glutamic acid dehydrogenase | “recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel” NCT04262479 ↗ |
| Modality | Vaccine | “who received subcutaneous GAD-alum vaccination” PMID 28357504 ↗ Mar 2017 |
| Route | Subcutaneous | “20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart” NCT00435981 ↗ |