DiaPrecise, A Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals at Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

Start Date09 Jul 2024

Sponsor / Collaborator

Diamyd Medical AB

CTIS2023-509021-53-00

/ Not yet recruitingPhase 2IIT

A follow-up project on the GADinLADA trial to test for the continued impact of HLA-DR3DQ2 on diabetes status and immune parameters 3 years after treatment with intranodal GAD-alum.

Start Date01 May 2024

Sponsor / Collaborator

Norwegian University of Science & Technology

NCT05018585

/ Active, not recruitingPhase 3

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults With Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

Start Date19 May 2022

Sponsor / Collaborator

Diamyd Medical AB

100 Clinical Results associated with Retogatein

100 Translational Medicine associated with Retogatein

100 Patents (Medical) associated with Retogatein

Literatures (Medical) associated with Retogatein

01 Aug 2025·JOURNAL OF IMMUNOLOGICAL METHODS

Development and performance evaluation of a novel, fully automated, high-throughput GAD65 autoantibody assay on the Phadia platform

Article

Author: Ettner, Virginie ; Filchtinski, Daniel ; Kayser, José ; Holz, Sanja ; Fiedler, Raimund ; Kristensen, Bjarne ; Schulte-Pelkum, Johannes ; Wilhelm, Isabel

OBJECTIVES:

In clinics, diabetes is determined by blood glucose levels or by glycosylated hemoglobin (HbA1c). However, to distinguish between Type 1 and Type 2 diabetes (T1D and T2D) for adequate treatment, patients are tested for the presence of Type 1 diabetes-relevant autoantibodies in the second tier. Anti-GAD65 autoantibody is one of the main markers for T1D in both pediatric and adult T1D patients. If the anti-GAD65 autoantibody is detectable, the patients have type 1 diabetes and need to be treated with insulin. In the clinical routine diagnostics of type 1 diabetes, GAD65-serology is performed using a special assay architecture known as bridging ELISA. Adapting these assays onto automated ELISA systems has shown to be a constant challenge, so they can be hardly applied for high throughput testing in a routine clinical laboratory.

METHODS:

We developed the first fully automated, high-throughput GAD65 autoantibody fluorescence enzyme immunoassay based on the bridging immunoassay format on Phadia instrument platform, termed EliA GAD65 and compared its performance with the bridging ELISA from RSR™ (GADAb ELISA) and the fully automated MAGLUMI® GAD65 chemiluminescence assay (CLIA) from Snibe Diagnostics.

RESULTS:

When tested for clinical performance, ROC Analysis of EliA GAD65 showed an Area under the curve (AUC) of 0.906 (95 % CI 0.864 to 0.949) compared to the AUC of 0.923 (95 % CI 0.884to 0.963) of GADAb ELISA with no significant difference between the two assays (p = 0.384). When adjusted to a specificity of 96 %, EliA GAD65 showed a sensitivity of 76 % (CI 95 % 66.4 % to 84.0 %) compared to a sensitivity of 74 % (95 % CI 64.6 % to 81.6 %) of GADAb ELISA. When the fully automated MAGLUMI® GAD65 CLIA was compared to GADAb ELISA, it showed a total agreement of 92.9 % (95 % CI 86.6 % to 96.4 %) with less positive samples detected in contrast to the total agreement of 100 % (95 % CI 96.7 % to 100 %) of EliA GAD65 to GADAb ELISA.

CONCLUSIONS:

Fully automated EliA GAD65 assay displays similar clinical characteristics as the well-established bridging GADAb ELISA and a higher agreement with the GADAb ELISA than the automated MAGLUMI® GAD65 CLIA.

01 Nov 2023·Diabetes, obesity & metabolism

A 1‐year pilot study of intralymphatic injections of GAD‐alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes

Article

Author: Ludvigsson, Johnny ; Hals, Ingrid K. ; Grill, Valdemar ; Björklund, Anneli ; Casas, Rosaura ; Balasuriya, Chandima

Abstract:

Aims:

To test, for the first time in latent autoimmune diabetes in adults (LADA), the effects of autoantigen‐specific immunotherapy by intralymphatic administration of aluminium‐formulated recombinant human glutamic acid decarboxylase 65 (GAD‐alum); specifically, to test if this treatment is safe, to test whether it induces a strong immunological response akin to a similar protocol in type 1 diabetes and to look for associations with preserved beta‐cell function.

Materials and Methods:

Three GAD‐alum injections, 4 μg each, were administered 1 month apart into an inguinal lymph node in 14 people with newly diagnosed LADA (age 30‐62 years) presenting with high levels of antibodies against glutamic acid decarboxylase (GADA). Adverse effects, immunological variables and beta‐cell function were monitored, with detailed measurements at 5 and 12 months from baseline.

Results:

Clinical adverse effects were minor and transient and measured laboratory variables were unaffected. All participants completed the study. Treatment raised levels of GADA, elicited strong effects on reactivity of peripheral blood mononuclear cells to GAD and raised cytokine/chemokine levels. Beta‐cell function appeared stable preferentially in the seven participants carrying human leukocyte antigen (HLA) haplotypes DR3DQ2, as assessed by C‐peptide glucagon tests ( P < 0.05 vs. seven non‐carriers).

Conclusion:

Intralymphatic treatment with GAD‐alum in LADA is without clinical or other safety concerns over a 12‐month period. As in a similar protocol used in type 1 diabetes, treatment exerts a strong immunological impact and is compatible with protection of beta‐cell function preferentially in HLA‐DR3DQ2 LADA patients. These findings pave the way for a randomized controlled trial in this important subgroup of LADA patients.

01 Oct 2022·BMJ open

Phase III, randomised, double-blind, placebo-controlled, multicentre trial to evaluate the efficacy and safety of rhGAD65 to preserve endogenous beta cell function in adolescents and adults with recently diagnosed type 1 diabetes, carrying the genetic HLA DR3-DQ2 haplotype: the DIAGNODE-3 study protocol

Article

Author: Casas, Rosaura ; Nowak, Christoph ; Lind, Marcus ; Eriksson, Linnea ; Widman, Martina ; Teixeira, Pedro F ; Lindqvist, Anton ; Hannelius, Ulf ; Ludvigsson, Johnny

Introduction:

Type 1 diabetes (T1D) is an autoimmune disease leading to the destruction of the insulin-producing beta cells resulting in insulin deficiency and hyperglycaemic. Today, no approved therapy exists to halt this detrimental immunologic process. In a recent phase 2b study, intralymphatic administration of recombinant human glutamic acid decarboxylase 65 kDa (rhGAD65) adsorbed to Alhydrogel adjuvant to individuals recently diagnosed with T1D and carrying the HLA DR3-DQ2 haplotype showed promising results in preserving endogenous insulin secretion, confirming the results of a large meta-analysis of three randomised placebo-controlled trials of subcutaneous rhGAD65. The aim of the current precision medicine phase 3 study is to determine whether intralymphatic administration of rhGAD65 preserves insulin secretion and improves glycaemic control in presumed responder individuals with recently diagnosed T1D carrying HLA DR3-DQ2.

Methods and analysis:

Individuals ≥12 and <29 years recently diagnosed with T1D (<6 months) will be screened for the HLA DR3-DQ2 haplotype, endogenous insulin production estimated by fasting C-peptide and presence of GAD65 antibodies. 330 patients are planned to be randomised to 3 monthly intralymphatic injections of rhGAD65 or placebo (both accompanied by oral vitamin D supplementation), followed by 22 months of follow-up. The study is powered to detect a treatment effect in the two coprimary endpoints; change from baseline in AUC (0-120min) C-peptide levels during a mixed meal tolerance test, and change from baseline in glycaemic control estimated by haemoglobin A1c at 24 months. Secondary endpoints include effects on glucose patterns collected by masked continuous glucose monitoring, proportion of patients in partial remission and number of episodes of severe hypoglycaemia and/or diabetic ketoacidosis.

Ethics and dissemination:

The trial is approved by Ethics Committees in Poland (124/2021), the Netherlands (R21.089), Sweden (2021-05063), Czech Republic (EK-1144/21), Germany (2021361) and Spain (21/2021). Results will be published in international peer-reviewed scientific journals and presented at national and international conferences.

Trial registration number:

EudraCT identifier: 2021-002731-32, NCT identifier: NCT05018585 .

News (Medical) associated with Retogatein

10 Apr 2026

·www.diamyd.com

Diamyd Medical discontinues DIAGNODE-3 following evaluation confirming futility; initiates strategic review

Diamyd Medical today announced that it will discontinue the Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in Stage 3 type 1 diabetes. 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. The interim analysis results, first announced on Friday March 27, were based on 174 evaluable participants followed from baseline to month 15. The results showed no clinically meaningful effect on C-peptide, a marker for endogenous insulin secretion, in the overall population or in pre-specified subgroups. In addition to this, the pre-specified criteria required to support continuation of the trial were not met. In an evaluation that included review of the data derivation, patient randomization, and statistical assumptions used for the interim analysis, no factors were identified that meaningfully affected the interpretation of the results. No new safety concerns have been identified. Available glycemic data, specifically HbA1c and Time in Range, are consistent with the C-peptide results and indicate a well-controlled patient population with no observable differences between the active and placebo arm at month 15. Diamyd Medical will initiate an orderly wind-down of the trial that prioritizes patient safety and meets all ethical and regulatory requirements. The Company will proceed with unblinding of the dataset and conduct a comprehensive analysis to better understand the outcome. The Company will assess the future potential and direction of its GAD-based immunotherapy program based on insights from this analysis. Strategic review and operational focus In parallel, the Board of Directors has initiated a formal review of the organization and strategic alternatives aimed at maximizing shareholder value. This includes evaluation of external assets, partnerships, and potential corporate transactions. The Company will also adjust its staffing and other costs to address the situation that has arisen. As part of this review, Diamyd Medical will continue to maintain and evaluate its manufacturing capabilities at its fully owned biomanufacturing facility in Umeå, Sweden, including the ongoing GMP certification process. The Company will explore opportunities for the facility as a stand-alone biomanufacturing company. About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial in patients with recent-onset (Stage 3) type 1 diabetes was discontinued following a pre-planned interim futility analysis which indicated that the study was unlikely to meet its primary endpoint. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB. Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser. For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: ulf.hannelius@diamyd.com Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68 E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com This information is information that Diamyd Medical is obliged to make public pursuant to the EU Market Abuse Regulation. The information was provided by the contact person above, for publication on 19.10 CET, April 10, 2026. Attachments: PDF version

Phase 2Phase 3Orphan DrugFast TrackClinical Result

29 Mar 2026

·www.diamyd.com

Diamyd Medical updates on the interim efficacy analysis of Phase 3 DIAGNODE-3 trial

Diamyd Medical on Friday March 27th announced that the pre-specified interim efficacy analysis on 174 out of 321 participants of the ongoing Phase 3 DIAGNODE-3 trial yielded results that were unexpected and not aligned with prior retrospective or prospective data. This lack of alignment underscores the need for thorough evaluation of the interim analysis results. 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. “This outcome is highly unexpected and not consistent with the totality of prior data,” said Ulf Hannelius, CEO of Diamyd Medical. “The absence of any observable effect on C-peptide, including in pre-specified subgroups, makes it critical to conduct a thorough evaluation. Our priority is to understand these surprising findings that we received late on Friday and determine the most appropriate path forward.” The Company will conduct a comprehensive assessment of the analysis results that were received late on Friday March 27. The Company’s core operations, including manufacturing activities, will continue as planned during this period. To ensure patient safety and full compliance with ethical and regulatory standards Diamyd Medical will engage with regulatory authorities to determine appropriate next steps. “The interim outcome is disappointing and not aligned with earlier results,” said Dr. Joshua Vieth, Senior Director of Research at Breakthrough T1D. “A thorough evaluation of the interim results will be essential to understand these findings. We support Diamyd Medical in this work that will inform next steps in the development of retogatein.” Diamyd Medical will report further findings as analyses progress and will continue to communicate transparently on conclusions and next steps. The Company will hold live conference calls tomorrow, Monday, March 30, 2026 at 8:30 am CET (Direkt Studios, link to access call at: https://www.youtube.com/live/XPy2VdMUArI) and 3:00 pm CET (DNB Carnegie, link to access call at: https://qcnl.tv/p/r0_qafjpYZQbdjGvj3SYbg). About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial in patients with recent-onset (Stage 3) type 1 diabetes was discontinued following a pre-planned interim futility analysis which indicated that the study was unlikely to meet its primary endpoint. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB. Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser. For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: ulf.hannelius@diamyd.com Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68 E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com The information was provided by the contact person above, for publication on 22.45 CET, March 29, 2026. Attachments: PDF version

Clinical ResultPhase 3Phase 2Orphan DrugFast Track

25 Mar 2026

·www.diamyd.com

Quarterly Report 2 25/26

September 2025 – February 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026 Cover photo Precision Medicine for type 1 diabetes Fully enrolled registrational Phase 3 program Diamyd Medical develops a proprietary platform of precision medicines for type 1 diabetes, a progressive autoimmune disease in which the immune system destroys the body’s own insulin production. The Company is advancing the fully enrolled registrational Phase 3 trial DIAGNODE-3 in the United States and Europe with an upcoming interim readout end of March 2026. Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. Further information is available on https://www.diamyd.com September 1, 2025 – February 28, 2026 Net sales: MSEK 0.3 (0.1), second quarter MSEK 0.1 (0.0) Net result: MSEK -111.7 (-81.0), second quarter MSEK -62.9 (-44.9) Result per share before and after dilution: SEK -0.6 (-0.8), second quarter: SEK -0.3 (-0.4) Cash flow from operating activities: MSEK -83.2 (-90.2), second quarter MSEK -39.5 (-48.4) Cash and short-term investments at February 28, 2026: MSEK 190.7 (103.8) Events during the second quarter Diamyd Medical deepens long-term manufacturing collaboration for retogatein Diamyd Medical announced the completion of screening in pivotal Phase 3 DIAGNODE-3 trial Diamyd Medical’s lead immunotherapy for type 1 diabetes received global non-proprietary name retogatein Diamyd Medical accelerated primary efficacy readout by 9 months in type 1 diabetes Phase 3 trial following FDA alignment and guidance Other events after the second quarter Diamyd Medical gives notice of extraordinary general meeting on April 8th, 2026 Diamyd Medical enters into equity financing agreements with new U.S. sector specialist investors for up to USD 125 million and announces full enrollment in Phase 3 trial Diamyd Medical receives Notice of Grant in Japan for insulin-based antigen therapy patent in type 1 diabetes Diamyd Medical announced that ADA will feature retogatein Phase 3-trial in dedicated symposium Diamyd Medical finalized the database for interim analysis readout in DIAGNODE-3 trial Diamyd Medical announced the strengthening of its IP-position in the US Comments by CEO Ulf Hannelius Dear Shareholders, Diamyd Medical has now reached a defining stage in the development of retogatein as we prepare for the interim efficacy readout from our pivotal Phase 3 trial DIAGNODE-3, anticipated on March 27, 2026. Earlier this week, we achieved a major operational milestone with the completion of randomization in the study. A total of 321 patients has now been randomized across 57 clinical sites in Europe and the United States, bringing this groundbreaking precision medicine trial to full enrollment. Importantly, and directly aligned with this milestone, we have secured significant new funding to support DIAGNODE-3 through its next phase. We recently entered into directed equity financing agreements with new U.S. sector specialist investors, raising approximately USD 25 million before transaction costs. In addition, the newly issued warrants may provide an additional USD 100 million upon full exercise. Together with the existing TO5 warrants, which can contribute approximately USD 35 million, this establishes a total potential financing capacity of around USD 160 million. Both the new warrants and the TO5 warrants can be exercised following the upcoming interim analysis, directly linking this potential additional financing to a key value-inflection point. This structure provides financial flexibility to scale investment in line with clinical outcomes, supporting completion of the Phase 3 program, preparations for potential commercialization as well as life cycle management and pipeline opportunities. The financing was executed at a pivotal moment for the program—following full enrollment and ahead of the interim analysis—and the participation of specialized U.S. healthcare investors further validates both the quality of our data and the potential of our precision medicine approach in type 1 diabetes. The upcoming interim analysis evaluates preservation of C-peptide from baseline to month 15, reflecting the body’s own insulin production, in a genetically defined patient population representing approximately 40 percent of individuals with the disease in Europe and the United States. Should the interim analysis demonstrate statistically significant efficacy, the results may support further regulatory interactions with the FDA regarding the potential Biologics License Application (BLA) pathway in the United States. The trial continues with follow-up of all participants toward the full study readout expected in the third quarter of 2027, intended to support a potential BLA for full approval. Scientific interest in our Phase 3 program continues to grow, and we are particularly pleased that DIAGNODE-3 has been selected for a dedicated symposium at the American Diabetes Association’s 86th Scientific Sessions in June 2026. The symposium will highlight the scientific rationale for precision medicine in type 1 diabetes and present the interim Phase 3 outcomes together with leading international experts in the field. Being selected for a dedicated scientific session at one of the world’s largest diabetes conferences underscores both the scientific relevance of our program and the increasing recognition of precision medicine approaches in autoimmune diabetes. In parallel with the clinical progress, our manufacturing capabilities in Umeå continue to advance. During the quarter, the Swedish Medical Products Agency conducted an inspection of our biomanufacturing facility as part of the ongoing process toward Good Manufacturing Practice (GMP) certification for the production of material for clinical studies. The inspection outcome was positive, and the observations raised were limited to minor findings that are currently being addressed in dialogue with the Agency ahead of their final assessment. Importantly, we also received constructive feedback from the Agency regarding requirements for future commercial manufacturing, providing valuable guidance as we continue developing our long-term production capabilities for retogatein. In parallel, we continue to work closely with our manufacturing partners to advance process validation, analytical methods and other CMC activities required for late-stage development and future commercialization. I am also very pleased to report that the long-term incentive program launched three years ago reached its first vesting during the quarter, with participants receiving shares after successfully meeting the program’s performance criteria, defined as a 50 percent increase in the Company’s market capitalization since its inception. This outcome reinforces the strong alignment between employees and shareholders. The team has executed in an exemplary fashion to advance both the Phase 3 program and our manufacturing capabilities in circumstances that periodically have been challenging. As we approach the interim analysis of DIAGNODE-3, the entire organization remains focused on disciplined execution across clinical development, regulatory engagement and manufacturing readiness. Our focus now is on delivering the upcoming milestone whilst continuing to advance the program toward the full Phase 3 readout and the next stages of regulatory engagement. I would like to extend my sincere gratitude to our employees, clinical investigators, partners and shareholders for their continued commitment and support. Stockholm, March 25, 2026 Ulf Hannelius President and CEO *** The above is an excerpt from the report. To read the complete report, please visit https://www.diamyd.com, or see attached PDF *** INVITATION TO PRESENTATION OF THE QUARTERLY REPORT 2 2025/2026 Diamyd Medical’s CEO Ulf Hannelius and CFO Niklas Axelsson will be interviewed in connection to the Company’s second quarterly report for the financial year 2025-26, published on March 25. The presentation will be held in English When: Wednesday March 25 at 09:00 am CEST Live webcast: https://www.youtube.com/live/qj2_tVpxIfY The YouTube chat is open for questions. The broadcast is produced by Biostock. The presentation will also be made available on www.diamyd.com About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US, is being conducted at 57 clinics in eight European countries and in the US in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Diamyd Medical is a shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB. Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser. Further information is available on https://www.diamyd.com For more information, please contact: Ulf Hannelius, President and CEO, ulf.hannelius@diamyd.com Niklas Axelsson, CFO, niklas.axelsson@diamyd.com Diamyd Medical AB (publ), Box 7349, SE-103 90 Stockholm, Sweden Phone: +46 8 661 00 26 E-mail: info@diamyd.com Reg. no: 556242-3797 The information was submitted for publication, through the agency of the contact persons set out above, at 08.15 CET on March 25, 2026. Attachments: Quarterly Report 2 2025/2026

Phase 3Fast TrackOrphan Drug

100 Deals associated with Retogatein

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB04963

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	Finland	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	France	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	Germany	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	Italy	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	Netherlands	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	Slovenia	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	Spain	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	Sweden	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	United Kingdom	Diamyd Medical AB	01 Jul 2008
Latent Autoimmune Diabetes in Adults	Phase 2	Sweden	Diamyd Medical AB	01 Dec 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04262479 (GADinLADA, CTgov)	Phase 2	Latent Autoimmune Diabetes in Adults	14	recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel+Vitamin D	ukidqmmhsp = vcdesjimak oudbuvytui (ehzwxanukf, ynkguxzscd - snjnupqxmk) View more	-	08 Jun 2025
NCT03345004 (DIAGNODE-2, CTgov)	Phase 2	Diabetes Mellitus, Type 1	109	Vitamin D+Diamyd (Active Arm)	sgjbqwwbqw(ymzkognlgh) = luhsvkeayz eqddgtbudh (jmfekitpzv, 1.715) View more	-	09 Jan 2023
NCT03345004 (DIAGNODE-2, CTgov)	Phase 2	Diabetes Mellitus, Type 1	109	Placebo for Diamyd (Placebo Arm)	sgjbqwwbqw(ymzkognlgh) = gfixcolohn eqddgtbudh (jmfekitpzv, 2.163) View more	-	09 Jan 2023
NCT02352974 (DIAGNODE \| DIAGNODE-1, CTgov)	Phase 1	Diabetes Mellitus, Type 1	12	Vitamin D+GAD-Alum	tpucrfglau = intacrcrha tyrhpahvpu (fzrrxypxmg, fxtdrlygjs - etghcykbdy) View more	-	27 Apr 2020
NCT02352974 (DIAGNODE-1, Biospace) Manual	Phase 1/2	Diabetes Mellitus, Type 1	12	Diamyd	vwrczissev(gwrxkwxorz) = batcrwxnps eaizwzeclh (hllfskzyrl ) View more	Positive	20 Dec 2019
NCT02464033 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	20	Vitamin D+Etanercept	lzyquruawn = lccknkwwjx caibyljxaq (ezzeslfzgs, jeqwuoufbc - albjrfjafa) View more	-	25 Sep 2019
NCT01122446 (DIAPREV-IT, CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Prediabetic State	50	Placebo comparator (Placebo Comparator)	ppkyeqvtde = fcynusbqwq ldoajhrbjk (vpnuunzplx, hvvuhzjxwr - dnhvpqlzsn) View more	-	06 May 2019
NCT01122446 (DIAPREV-IT, CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Prediabetic State	50	Diamyd (Alum-GAD (Diamyd))	ppkyeqvtde = vvmbcdmhjq ldoajhrbjk (vpnuunzplx, gleikddywx - mclhiqbgbl) View more	-	06 May 2019
NCT00529399 (TN08, CTgov)	Phase 2	Diabetes Mellitus, Type 1	145	GAD-Alum (GAD-alum)	umniibjxwd(uubbpenofg) = xozbmtoses rbwknmlygn (oggjgmdmhk, qrvxnarmbf - pfxmypkgto) View more	-	07 Dec 2016
NCT00529399 (TN08, CTgov)	Phase 2	Diabetes Mellitus, Type 1	145	Alum (GAD-alum Plus Alum)	umniibjxwd(uubbpenofg) = xeopdxtlrq rbwknmlygn (oggjgmdmhk, pturbogmoe - mrlujougig) View more	-	07 Dec 2016
NCT00837759 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	7	Insulin+Sitagliptin+Lansoprazole+GAD65	nuiuuhhieg(ggxuobfcsy) = btxybsghqb bnflihccqg (olelrnifzc, 0.53) View more	-	24 Oct 2012

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis