GV1001

Phase 3Small molecule

SSamsung Pharmaceutical Co., Ltd.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Moderate to Severe Alzheimer's DiseaseNot yet recruiting

Moderate to Severe Alzheimer's DiseasePhase 3

Not yet recruiting

Timeline

Expected Milestones

Q3 2031

Phase 3Not yet recruiting

Moderate to Severe Alzheimer's Disease

NCT05303701

Clinical

Trials by Indication[1]

Pancreatic Cancer2 trials

GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

Terminated·PPharmexa A/S·Phase 3·NCT00358566·360 enrolled

A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Unknown status·SSamsung Pharmaceutical Co., Ltd.·Phase 3·NCT02854072·148 enrolled

Progressive Supranuclear Palsy2 trials

GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

Completed·GGemVax & Kael·Phase 2·NCT05819658·78 enrolled

Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

Completed·GGemVax & Kael·Phase 2·NCT06235775·67 enrolled

Melanoma1 trial

Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

Completed·OOslo University Hospital·Phase 1/2·NCT01247623

Mild to Moderate Alzheimer's Disease1 trial

GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD)

Completed·GGemVax & Kael·Phase 2·NCT05189210·199 enrolled

Efficacy and Safety1 trial

Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients

Completed·GGemVax & Kael·Phase 2·NCT03184467·96 enrolled

6 more indications

Moderate to Severe Alzheimer's Disease1 trial

GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD)

Not yet recruiting·SSamsung Pharmaceutical Co., Ltd.·Phase 3·NCT05303701·750 enrolled

Alzheimer's Disease (AD)1 trial

GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)

Withdrawn·GGemVax & Kael·Phase 2·NCT03959553

Phase II Clinical Trial1 trial

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH

Completed·GGemVax & Kael·Phase 2·NCT02855892·161 enrolled

Tics1 trial

Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects

Completed·GGemVax & Kael·Phase 1·NCT06625710·59 enrolled

Hepatocellular Carcinoma1 trial

A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.

Completed·PPharmexa A/S·Phase 2·NCT00444782·41 enrolled

Non-Small Cell Lung Cancer1 trial

Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer

Unknown status·KKael-GemVax Co., Ltd.·Phase 3·NCT01579188·600 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for GV1001. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — GV1001 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for GV1001. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Samsung Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSamsung Pharmaceutical Co., Ltd.