MedPath

C-peptide

Generic Name
C-peptide
Drug Type
Small Molecule
Chemical Formula
C129H211N35O48
CAS Number
59112-80-0
Unique Ingredient Identifier
O2J76Y002M

Advanced Drug Monograph

Access comprehensive pharmacological analysis, clinical applications, and therapeutic considerations.

Background

C-peptide is under investigation in clinical trial NCT00278980 (Effect of C-peptide on Diabetic Peripheral Neuropathy).

Clinical Trials
Related News

Diamyd Medical's Diamyd® Receives Positive FDA Feedback for Accelerated Approval in Type 1 Diabetes

• Diamyd Medical received positive feedback from the FDA regarding an Accelerated Approval pathway for Diamyd® in Stage 3 Type 1 Diabetes patients with the HLA DR3-DQ2 genotype. • The FDA acknowledged C-peptide as a surrogate endpoint, which could allow for Accelerated Approval based on demonstrating significant treatment-related benefits on C-peptide levels. • A Phase 3 trial, DIAGNODE-3, evaluating the safety and efficacy of Diamyd® in Type 1 Diabetes, had a successful interim analysis, recommending continuation without modifications. • The company is in ongoing discussions with the FDA to determine the requirements for a Biologics License Application (BLA) under the Accelerated Approval pathway.

Diamyd Redosing Shows Promise in Type 1 Diabetes Trial

• Redosing with Diamyd (GAD-Alum) in patients with Type 1 Diabetes demonstrates sustained safety and potential efficacy in a pilot trial. • The DIAGNODE-B trial showed stabilized endogenous insulin production, improved glycemic control, and reduced insulin requirements over 12 months. • Immunological markers indicated sustained immune modulation, with increased GAD65-induced cytokine responses and antibody titers. • The findings support Diamyd's potential as a precision medicine therapy for preserving beta-cell function in Type 1 Diabetes.

Sernova's Cell Pouch Bio-Hybrid Organ Shows Promise in Type 1 Diabetes Clinical Trial

• Sernova Biotherapeutics' Phase 1/2 clinical trial for its Cell Pouch Bio-hybrid Organ has received DSMB approval to enroll the final patient in Cohort B and advance to Cohort C in H2 2025. • The implantable device has demonstrated islet cell survival in Type 1 diabetes patients for up to five years with no evidence of detrimental fibrosis, supporting insulin independence following treatment. • Following completion of the current trial, Sernova plans to launch a new clinical trial using induced pluripotent stem cell-derived islet-like clusters in collaboration with Evotec.

Vertex Halts VX-264 Diabetes Treatment After Phase 1/2 Trial Fails to Meet Efficacy Endpoint

• Vertex Pharmaceuticals has discontinued development of VX-264, an encapsulated islet cell therapy for Type 1 diabetes, after Phase 1/2 trial data showed insufficient C-peptide production despite acceptable safety profile. • The company's lead T1D candidate zimislecel (VX-880) remains on track, with pivotal trial enrollment expected to complete in H1 2025 and regulatory submissions planned for 2026. • Vertex continues to advance multiple research-stage immunoprotective approaches for Type 1 diabetes, while conducting further analyses of the VX-264 trial results to understand the treatment's limitations.

Sana Biotechnology's UP421 Therapy Shows Promising Results in Type 1 Diabetes

Morgan Stanley analyst Vikram Purohit reaffirms a Buy rating for Sana Biotechnology, citing promising interim results from the UP421 therapy in Type 1 Diabetes, which showed no adverse effects and evidence of immune evasion, indicating a strong proof of concept.

Sana Biotechnology's HIP Technology Shows Promise in Type 1 Diabetes Islet Cell Transplant Study

• Sana Biotechnology's UP421 demonstrates survival and function of transplanted islet cells in a type 1 diabetes patient without immunosuppression. • The first-in-human study shows HIP-engineered cells evade immune detection, producing insulin as indicated by increased C-peptide levels. • MRI scans confirm graft survival 28 days post-transplantation, with no reported safety issues, suggesting potential for a curative T1D treatment. • These results support the development of Sana's SC451, a stem cell-derived islet cell program, offering hope for scalable T1D therapies.

Diamyd Medical Advances Toward Accelerated Approval for Diamyd® in Type 1 Diabetes

• Diamyd Medical received positive feedback from the FDA on its Phase 3 DIAGNODE-3 trial, aligning with requirements for Accelerated Approval based on interim efficacy data. • The FDA concurred on the suitability of the safety dataset and confirmatory evidence, including data from DIAGNODE-3 and previous trials, for potential accelerated approval of Diamyd®. • Agreement was reached with the FDA on evaluating stimulated C-peptide levels and HbA1c as co-primary endpoints at the 24-month final analysis for both accelerated and full approvals. • Breakthrough T1D is providing Diamyd Medical with USD 1.75 million in expanded support for the DIAGNODE-3 Phase 3 trial, facilitating a potential regulatory filing for approval.

Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target for Early Readout

• Diamyd Medical's DIAGNODE-3 trial, a Phase 3 precision medicine study, has recruited 180 patients, surpassing the target for its planned early readout in March 2026. • The early readout is intended to support a potential accelerated Biologics License Application (BLA) to the FDA for Diamyd® in Type 1 Diabetes. • DIAGNODE-3 evaluates Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes, focusing on the HLA DR3-DQ2 haplotype. • The trial assesses the preservation of endogenous insulin production (C-peptide) and glycemic control (HbA1c) over 24 months in approximately 330 patients.

Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target, Anticipates Early Readout

• Diamyd Medical's DIAGNODE-3 Phase 3 trial has recruited 180 patients, surpassing the target for its early readout planned in March 2026. • The early readout is intended to support a potential accelerated Biologics License Application (BLA) for Diamyd®. • DIAGNODE-3 assesses Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes, focusing on preserving insulin production. • The FDA has granted Diamyd® Fast Track designation and acknowledged C-peptide as a surrogate endpoint, potentially accelerating its approval pathway.

Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target, Anticipates Early Readout

• Diamyd Medical's DIAGNODE-3 Phase 3 trial, evaluating Diamyd® for Type 1 Diabetes, has reached its initial recruitment target of 180 patients. • This milestone supports an early data readout expected around March 2026, potentially enabling an accelerated Biologics License Application (BLA) submission. • The trial assesses Diamyd®'s ability to preserve endogenous insulin production in a genetic subgroup of individuals with newly diagnosed Stage 3 Type 1 Diabetes. • DIAGNODE-3 is continuing recruitment to reach a total of approximately 330 patients to ensure comprehensive data collection over 24 months.

Diamyd Medical's DIAGNODE-3 Trial Reaches Recruitment Milestone, Eyes Accelerated Approval

• Diamyd Medical's DIAGNODE-3 Phase 3 trial, evaluating Diamyd® for Type 1 Diabetes, has recruited 180 patients, surpassing the target for an early readout. • The early readout, expected around March 2026, is designed to support a potential accelerated Biologics License Application (BLA) submission to the FDA. • DIAGNODE-3 assesses Diamyd®'s ability to preserve insulin production and improve glycemic control in a genetic subgroup of individuals with Type 1 Diabetes. • Diamyd® has received Fast Track designation and C-peptide is acknowledged as a surrogate endpoint, potentially expediting its approval for Type 1 Diabetes.

Diamyd Immunotherapy Shows Robust Efficacy in Type 1 Diabetes Patients with HLA DR3-DQ2

• Meta-analysis of Diamyd trials reveals significant C-peptide preservation in HLA DR3-DQ2 positive Type 1 Diabetes patients. • Combined analysis shows a 48.3% improvement in C-peptide preservation and a reduction in HbA1c with Diamyd treatment. • Diamyd's effect on glycemic control includes reduced hyperglycemic episodes, duration, and amplitude. • Ongoing Phase 3 trial DIAGNODE-3 aims to confirm Diamyd's efficacy and safety in recent-onset T1D individuals.

Diamyd Demonstrates Robust Treatment Effects in Type 1 Diabetes Trials

• Meta-analysis of Diamyd trials reveals significant C-peptide preservation in DR3-DQ2 positive patients with Type 1 Diabetes, suggesting potential for precision medicine. • Combined analysis of 208 patients showed a 48.3% improvement in C-peptide preservation (p < 0.0001) and a reduction in HbA1c of -4.8 mmol/mol (p = 0.0044). • DIAGNODE-2 data indicates Diamyd significantly lowers the number, duration, and amplitude of hyperglycemic excursions, improving glycemic control. • Diamyd Medical is advancing DIAGNODE-3, a Phase 3 trial, with potential for accelerated FDA approval based on C-peptide preservation data expected around March 2026.

Diamyd's GAD-Alum Immunotherapy Shows Promise in Type 1 Diabetes Redosing Trial

• A clinical trial evaluating redosing of Diamyd's GAD-Alum immunotherapy in Type 1 Diabetes shows promising results, with sustained insulin production and improved glycemic control. • The DIAGNODE-B pilot trial demonstrated the safety and tolerability of redosing GAD-Alum, with no severe adverse events reported during the 12-month follow-up. • Data analysis reveals Diamyd significantly lowers the number, duration, and amplitude of hyperglycemic excursions, improving glycemic control in patients. • Further analysis of Diamyd's clinical trials supports its potential as a precision medicine approach to slow Type 1 Diabetes progression, especially in HLA DR3-DQ2 positive patients.

Diamyd Immunotherapy Shows Robust Efficacy in Type 1 Diabetes Patients with HLA DR3-DQ2

• Meta-analysis of Diamyd trials reveals significant C-peptide preservation in HLA DR3-DQ2 positive Type 1 Diabetes patients. • Combined analysis demonstrates a 48.3% improvement in C-peptide preservation and reduction in HbA1c with Diamyd treatment. • Data from DIAGNODE-2 shows Diamyd lowers the number, duration, and amplitude of hyperglycemic excursions. • Ongoing Phase 3 trial DIAGNODE-3 aims to confirm Diamyd's efficacy, with potential accelerated FDA approval in 2026.

Diamyd Medical Partners with INNODIA to Boost Type 1 Diabetes Trial

• Diamyd Medical collaborates with INNODIA to enhance patient recruitment for the DIAGNODE-3 trial, a Phase 3 study for Type 1 Diabetes. • The partnership aims to increase awareness of Type 1 Diabetes and Diamyd® treatment across INNODIA's European clinical network. • DIAGNODE-3 evaluates Diamyd®'s efficacy in preserving insulin production and improving blood glucose control in recent-onset Type 1 Diabetes patients. • The collaboration supports Diamyd Medical's goal of a potential accelerated Biologics Licensing Application in the U.S. for Diamyd®.

AMX0035 Shows Sustained Improvements in Wolfram Syndrome Patients in Phase 2 Trial

• Amylyx Pharmaceuticals' AMX0035 demonstrated sustained improvements in pancreatic function in adults with Wolfram syndrome in a Phase 2 trial. • The HELIOS trial showed improvements in C-peptide response, glycemic control, and visual acuity over 24 weeks of treatment with AMX0035. • Longer-term data up to 48 weeks indicated sustained improvements in C-peptide and HbA1c levels, suggesting potential for disease trajectory modification. • AMX0035 was generally well-tolerated, with a safety profile consistent with prior data, supporting further investigation in a Phase 3 program.

Diamyd Medical Pursues Accelerated Approval for Diamyd® in Type 1 Diabetes

• Diamyd Medical is set to pursue an accelerated approval pathway in the U.S. for Diamyd® for Stage 3 Type 1 Diabetes. • The FDA has acknowledged C-peptide levels as a surrogate endpoint, potentially expediting the approval process for Diamyd®. • Interim data from the DIAGNODE-3 Phase 3 trial, expected around March 2026, will form the basis for the BLA submission. • The DIAGNODE-3 trial is enrolling patients with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype across multiple sites.
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