Drugs / TERTOMOTIDE
TERTOMOTIDE
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06625710 | Oct 2024 → Aug 2025 | neurodegenerative disease | GemVax & Kael | Completed | No outcome recorded |
| Phase 1 | NCT01342224 | Jan 2011 → Jun 2012 | pancreatic adenocarcinoma | Providence Health & Services | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01247623 | Jan 2005 → Sep 2011 | melanoma | Oslo University Hospital | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06235775 | Dec 2023 → Sep 2025 | progressive supranuclear palsy | GemVax & Kael | Completed | No outcome recorded |
| Phase 2 | NCT05819658 | Jun 2023 → Oct 2024 | progressive supranuclear palsy | GemVax & Kael | Completed | No outcome recorded |
| Phase 2 | NCT05189210 | Oct 2022 → Apr 2025 | — | GemVax & Kael | Completed | No outcome recorded |
| Phase 2 | NCT03959553 | Sep 2019 → Aug 2021 | Alzheimer disease | GemVax & Kael | Withdrawn | No outcome recorded |
| Phase 2 | NCT03184467 | Sep 2017 → Sep 2019 | Alzheimer disease | GemVax & Kael | Completed | Met primary |
| Phase 2 | NCT02855892 | Oct 2015 → Oct 2016 | benign prostatic hyperplasia | GemVax & Kael | Completed | No outcome recorded |
| Phase 2 | NCT00444782 | Nov 2006 → Apr 2008 | hepatocellular carcinoma | Pharmexa A/S | Completed | Missed primary |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT05303701 | Jul 2027 → Jan 2028 expected | Alzheimer disease | Samsung Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02854072 | Nov 2015 → May 2018 | malignant pancreatic neoplasm | Samsung Pharmaceutical Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT01579188 | May 2012 → May 2016 | non-small cell lung carcinoma | Kael-GemVax Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT00425360 | Sep 2006 → Mar 2013 | malignant pancreatic neoplasm | Royal Liverpool University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00358566 | Jun 2006 → Aug 2008 | malignant pancreatic neoplasm | Pharmexa A/S | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00509457 | Nov 2006 → Aug 2009 | non-small cell lung carcinoma | Oslo University Hospital | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01223209 Background | Aug 2010 → Dec 2011 | carcinoma | Lytix Biopharma AS | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-05-29 | GemVax & Kael | Regulatory GemVax Secures Orphan Medicinal Product Designation in Europe, Following Approvals in the United States and Republic of Korea gemvax.com ↗
GemVax & KAEL (082270, hereinafter GemVax) announced on May 29 that the European Medicines Agency (EMA) has granted Orphan Medicinal Product (OMP) designation to 'GV1001', the company’s investigational treatment for progressive supranuclear palsy (PSP). |
| 2025-05-07 | GemVax & Kael | Regulatory GemVax’s GV1001 Receives FDA Fast Track Designation for Progressive Supranuclear Palsy Treatment gemvax.com ↗
GemVax & KAEL (KOSDAQ: 082270) announced on May 7 that the United States Food and Drug Administration (FDA) has granted Fast Track designation to GV1001, the company’s investigational therapeutic candidate for the treatment of progressive supranuclear palsy (PSP). |
| 2025-05-02 | GemVax & Kael | Regulatory GemVax Receives Orphan Drug Designation from U.S. FDA for Progressive Supranuclear Palsy Treatment gemvax.com ↗
GemVax & KAEL Co., Ltd. (KOSDAQ: 082270, “GemVax”) announced on May 2 that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to GV1001, the company’s investigational therapeutic candidate for the treatment for progressive supranuclear palsy (PSP). |
| 2024-11-26 | GemVax & Kael | Results GemVax Presents Poster on Topline Results of PSP Phase 2a Trial at International Conference gemvax.com ↗
Through the poster presentation, GemVax reported that the Phase 2a trial results demonstrated that the group receiving GV1001 (0.56 mg) experienced a 48% delay in disease progression compared to the placebo group. |
| 2024-10-29 | GemVax & Kael | Results GemVax Announces Topline Results from Phase 2a Progressive Supranuclear Palsy Clinical Trial at Neuro2024 gemvax.com ↗
GemVax Announces Topline Results from Phase 2a Progressive Supranuclear Palsy Clinical Trial at Neuro2024 |
| 2024-09-30 | GemVax & Kael | Results GemVax's GV1001 Reduces Alzheimer’s Amyloid Beta to Normal Levels gemvax.com ↗
The study found that GV1001 enhances the clearance of amyloid beta by promoting microglial migration toward amyloid plaques and inducing phagocytosis. |
| 2024-06-05 | GemVax & Kael | Results GemVax Confirms Potential for Preventing Alzheimer's Disease in Periodontitis Patients with GV1001 gemvax.com ↗
The study indicated that administering GV1001 to mice with periodontitis induced by Porphyromonas gingivalis (Pg) and lacking apolipoprotein E (ApoE) helped suppress both periodontal disease and vascular inflammation. |
| 2024-02-23 | GemVax & Kael | Regulatory GV1001, GemVax's Progressive Supranuclear Palsy Treatment, Designated as Orphan Drug by Ministry of Food and Drug Safety gemvax.com ↗
GemVax & KAEL Co., Ltd. (GemVax, 082270) announced on the 23rd that its progressive supranuclear palsy (PSP) treatment, 'GV1001,' was designated as a 'development-stage orphan drug' by the Ministry of Food and Drug Safety on the 22nd. |
| 2024-02-13 | GemVax & Kael | Regulatory GemVax Receives FDA Phase 2 IND Approval for 'GV1001' in the Treatment of Progressive Supranuclear Palsy gemvax.com ↗
GemVax Receives FDA Phase 2 IND Approval for 'GV1001' in the Treatment of Progressive Supranuclear Palsy |
| 2021-06-07 | Samsung Pharmaceutical Co., Ltd. | Results 삼성제약, 젬백스 개발 췌장암 신약 리아백스, “화려한 귀환” sspharm.co.kr ↗
삼성제약은 지난 4일(현지시간) 췌장암 신약 ‘리아백스주 (코드명 GV1001)’의 국내 3상 임상시험 결과를 미국임상종양학회(ASCO) 연례학술대회에서 발표했다고 7일 밝혔다. |
| 2020-12-28 | Samsung Pharmaceutical Co., Ltd. | Results 삼성제약, 췌장암 치료제 리아백스 3상 임상시험 결과 발표 sspharm.co.kr ↗
결과보고서에 따르면, GV1001은 췌장암 환자에게 안전하게 투여할 수 있는 약제이며 젬시타빈/카페시타빈과 GV1001 병용(Gemcitabine/capecitabine+GV1001) 투여 시에 젬시타빈/카페시타빈(Gemcitabine/capecitabine) 투여 대비 median OS(생존 중간값) 및 TTP(종양 진행까지의 시간)에서 통계적으로 유의한 차이를 보인 것으로 확인됐다(p=0.021). |
| 2019-12-10 | Mediforum Ltd., Co. | Results 암보다 고약하다는 치매 질환…난공불락 정복 나선 K바이오 mediforum.co.kr ↗
임상 결과 손상된 신경세포에 GV1001을 투약했을 때 비교 물질인 생리식염수보다 세포 재생 효과가 5배 이상 뛰어난 것으로 나타났다. |
All press releases naming this drug 13 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TERTOMOTIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108308 ↗ |
| Known as | GV1001 | “GV1001 is a peptide vaccine in development to treat cancer.” NCT01223209 ↗ |
| Known as | Htert (534-549) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108308 ↗ |
| Known as | Tertomotida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108308 ↗ |
| Action | Inhibit | “GV1001 inhibits neurotoxicity, apoptosis, and the production of reactive oxygen species induced by amyloid beta (Aβ)” NCT05303701 ↗ |
| Modality | Vaccine | “telomerase peptide vaccine GV1001” NCT00425360 ↗ |
| Route | Other | “telomerase peptide vaccine GV1001 ID on days 1, 3, and 5 in week 9” NCT00425360 ↗ |