Tertomotide
A telomerase peptide first built as a cancer vaccine, which failed its large pancreatic cancer trial and has since been tested in Alzheimer's disease and enlarged prostate
Tertomotide, better known as GV1001, is a 16-amino-acid stretch of human telomerase reverse transcriptase (hTERT), the enzyme many cancers use to keep dividing. It was designed as a vaccine to teach the immune system to attack telomerase-making tumour cells. The UK TeloVac phase 3 trial in advanced pancreatic cancer found no survival benefit, but a later Korean phase 3 in patients with high blood eotaxin did, and Korea's regulator had conditionally approved it for pancreatic cancer in 2014 as Riavax. Laboratory work then found it enters cells and acts on gonadotropin-releasing hormone receptors, which led to trials in Alzheimer's disease and benign prostatic hyperplasia. It is not approved in the US or EU.
Used in human trials: 0.56 mg, Days 1, 3 and 5, once in weeks 2–4 and 6, then monthly, Injection (route not stated in the abstract) (Eotaxin-high advanced pancreatic cancer, KG4/2015 phase 3 (with gem...) Details ↓
Recommended Dosing
Used in human trials
There is no FDA label. A label from outside the US exists (see the regulatory status on this page) but was not read for this page: these are amounts given in published trials, not recommendations.
What is it?
Telomerase lets cells keep their chromosome ends long enough to go on dividing. Most cancers switch it on, while most normal adult tissues do not, which makes its catalytic subunit, hTERT, an attractive vaccine target. GV1001 is a 16-amino-acid piece of hTERT chosen because it fits many HLA class II molecules, so a wide range of patients can present it to helper T cells, and because it also carries sequences that killer T cells may recognise. In early phase 1 and 2 trials in pancreatic and lung cancer, more than half of vaccinated patients developed T cells against it, and those who did tended to live longer.
The vaccine was given as an injection into the skin together with GM-CSF, an immune-stimulating growth factor. Immune studies in long-term survivors found broad T-cell responses that spread from the GV1001 sequence to other parts of hTERT, a pattern not seen in patients who responded immunologically but not clinically. Elsewhere the responses were weak: in pancreatic cancer with gemcitabine they were small and short-lived, and in six patients with cutaneous T-cell lymphoma no tumour shrank and one progressed.
The decisive test was TeloVac, a UK phase 3 trial of 1,062 patients with locally advanced or metastatic pancreatic cancer. Adding GV1001 to gemcitabine and capecitabine, either alongside chemotherapy or after it, did not improve overall survival, which was 7.9 months with chemotherapy alone, 6.9 months with sequential vaccination and 8.4 months with concurrent vaccination. Cytokine measurements suggested patients with high blood eotaxin might benefit, and the Korean KG4/2015 phase 3 trial tested that: in 148 eotaxin-high patients, median survival was 11.3 months with GV1001 against 7.5 months without. Korea's Ministry of Food and Drug Safety had already given it conditional approval for advanced pancreatic cancer in September 2014, under the name Riavax.
Laboratory work in the 2010s showed GV1001 does more than act as an antigen. It crosses cell membranes by riding on heat shock proteins 70 and 90 outside the cell, it binds gonadotropin-releasing hormone receptors and triggers cAMP signalling through them, and in cell and animal models it protected nerve cells from amyloid-beta, lowered amyloid and tau in Alzheimer's mice, shrank prostate cancer xenografts and reduced damage after stroke. A 2026 study named bradykinin receptor 1 as a binding target in microglia.
These findings moved it into new diseases. In a Korean phase 2 trial in moderate-to-severe Alzheimer's disease, 1.12 mg under the skin slowed the decline in the Severe Impairment Battery against placebo over 24 weeks, while 0.56 mg did not; a phase 3 is registered. In benign prostatic hyperplasia, a phase 2 trial improved urinary symptom scores and a phase 3 trial found effects comparable to finasteride. It is not approved in the US or the EU, and whether the Korean conditional approval is still in force was not confirmed.
Mechanism of Action
GV1001 was designed to make the immune system attack telomerase-expressing cancer cells; later studies found it also enters cells and signals through gonadotropin-releasing hormone receptors, effects unrelated to vaccination.
Telomerase vaccine
It binds many HLA class II molecules and can raise CD4 and CD8 T-cell responses against hTERT (2009 review); in responders these spread to other hTERT epitopes (2012 study).
Cell entry
It carries cargo into cells through extracellular heat shock proteins 70 and 90, a property described in a 2016 review.
GnRH receptor signalling
It binds the gonadotropin-releasing hormone receptor and activates cAMP signalling; repeated doses lowered testosterone in mice (2019 study), and blocking the receptor removed its benefits in Alzheimer's mice (2024 study).
Neuroprotection in models
It protected neural stem cells from amyloid-beta and oxidative injury and, in mice, reduced amyloid and tau and helped microglia clear plaques (2014 to 2026 studies).
Published Research
Studies of tertomotide (GV1001) itself, read from their PubMed abstracts: cancer vaccine trials in pancreatic, colorectal and skin lymphoma, immune studies, trials in Alzheimer's disease and benign prostatic hyperplasia, reviews, and cell and animal work. Studies of other telomerase vaccines are not carded.
TeloVac: no survival benefit
In 1,062 UK patients with advanced pancreatic cancer randomised to gemcitabine and capecitabine alone or with GV1001 (0.56 mg intradermally with GM-CSF) given after or alongside chemotherapy, median survival was 7.9, 6.9 and 8.4 months, with no significant difference. Neutropenia, fatigue and pain were the commonest severe effects in all groups.
KG4/2015: benefit when eotaxin is high
In 148 Korean patients with untreated advanced pancreatic cancer and high serum eotaxin, adding GV1001 0.56 mg (days 1, 3 and 5, weekly in weeks 2 to 4 and 6, then monthly) to gemcitabine and capecitabine lengthened median survival from 7.5 to 11.3 months and time to progression from 4.5 to 7.3 months. Severe adverse events were similar (77% vs 73%).
With gemcitabine: weak immune responses
In 21 patients with inoperable pancreatic cancer, GV1001 with GM-CSF and gemcitabine on three schedules caused only mild vaccine side effects; telomerase-specific responses appeared in 10 of 17 vaccinated patients but were weak and transient, and regulatory T cells fell.
Second-line colorectal cancer, phase 2
In 56 Korean patients with metastatic colorectal cancer after failed first-line chemotherapy, GV1001 with chemotherapy gave disease control in 90.9%, responses in 34.1%, median progression-free survival of 7.1 months and survival of 12.8 months. No patient had a positive skin-test immune response and only 28% had T-cell proliferation; eotaxin did not predict outcome.
No responses in cutaneous T-cell lymphoma
Six patients with cutaneous T-cell lymphoma vaccinated with GV1001 and GM-CSF had no objective response and one progressed; only one developed a GV1001-specific T-cell response, which did not change the immune cells in the skin lesions.
Epitope spreading in clinical responders
T-cell clones from a lung cancer patient in complete remission after vaccination showed a broad CD4 response to GV1001 and reactions to several other hTERT epitopes, including a CD8 epitope inside GV1001; patients who responded immunologically but not clinically lacked this spreading.
Alzheimer's disease, phase 2
In 96 Korean patients with moderate-to-severe Alzheimer's disease already on donepezil, 1.12 mg under the skin weekly for 4 weeks, then every 2 weeks to week 24, slowed the fall in the Severe Impairment Battery score against placebo; 0.56 mg did not. Most secondary measures did not differ, and adverse events were similar across groups.
Alzheimer's trial: language subscale
A post hoc look at the same phase 2 trial found the 1.12 mg dose's clearest effect at 24 weeks was on the language subscale of the Severe Impairment Battery, in both analysis sets, with adverse events similar to placebo.
Benign prostatic hyperplasia, phase 2
In 161 men with BPH given seven intradermal injections over 12 weeks (0.4 mg or 0.56 mg every 2 weeks, or 0.56 mg every 4 weeks) or placebo, the two 2-weekly schedules improved the prostate symptom score at week 13 (about −7 vs −3.5), and all doses shrank the prostate slightly; no adverse events were attributed to the drug.
BPH phase 3 against finasteride
In 423 men randomised to GV1001 0.56 mg or 1.12 mg every 2 weeks to week 22, or finasteride 5 mg, symptom scores and urine flow improved in all groups to a similar degree; finasteride shrank the prostate and lowered PSA more, while only finasteride reduced erectile function scores.
The vaccine's design
This review describes GV1001 as a 16-amino-acid hTERT sequence that binds multiple HLA class II molecules, reports T-cell responses in over half of patients in early pancreatic and lung cancer trials without important toxicity, and links durable responses to longer survival.
Where it stood in 2010
A review of the biological rationale, immunogenicity and clinical activity of GV1001, then in advanced clinical development, set against other telomerase-targeted immunotherapies.
A cell-penetrating peptide
This review describes GV1001's unexpected ability to carry proteins, DNA and small RNAs into cells by binding extracellular heat shock proteins 90 and 70, and suggests this may add to its immune effect.
Repurposing for the nervous system
This review covers animal evidence in Alzheimer's disease, stroke, autoimmune encephalomyelitis and depression, mechanisms including GnRH receptor signalling and mitochondrial protection, and the phase 2 Alzheimer's results, and names phase 3 confirmation as the next step.
Longer life in Alzheimer's mice
Old 3xTg Alzheimer's mice given 1 mg/kg under the skin three times a week lived longer; labelled GV1001 crossed the blood-brain barrier, and BACE, amyloid-beta, neurodegeneration and senescence markers fell.
Works through GnRH receptors
In middle-aged and old 3xTg Alzheimer's mice it improved memory and lowered amyloid oligomers and phosphorylated tau while calming inflammatory glia; it bound GnRH receptors with high affinity, and blocking those receptors removed its effects.
Microglia clear more plaque
In 5xFAD mice it reduced amyloid plaques and rescued synapses and memory by driving microglia toward plaques and amyloid uptake; bradykinin receptor 1 was identified as its binding target, acting through mTORC2.
Protection after stroke in rats
In rats with temporary middle cerebral artery occlusion, GV1001 given at reperfusion reduced infarct growth and improved behaviour, and in cultured neurons and neural stem cells it countered oxygen-glucose deprivation injury.
A GnRH receptor ligand in prostate cancer
GV1001 bound the GnRH receptor and activated cAMP signalling while opposing leuprolide's calcium signal; repeated injections lowered testosterone in mice, and it slowed growth of LNCaP prostate cancer xenografts.
Bone formation in mice
GV1001 bound the enzyme Pin1, stabilised the bone-forming transcription factors Runx2 and Osterix and increased osteoblast activity in culture; in mice whose ovaries had been removed it raised bone mineral density.
Protects neural stem cells from amyloid
In rat neural stem cells, GV1001 protected against amyloid-beta 25-35 oligomers in a dose-dependent way, restoring viability, proliferation and migration and lowering free radicals and death-related proteins.
Dosing Data
Korea's conditional approval of Riavax was read from a trial report, not from the Korean label, so no label row is shown. These are doses given in the published human trials carded above; amounts are per injection, not per kilogram.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
What a Buyer Needs to Know
What is sold, how it is mixed, stored and taken, and what is known about its safety, quality and legal status. Each part names its source. Where we have none, it says unknown.
What is sold
Unknown: we hold no label and no published test that says what forms or vial sizes Tertomotide is sold in. A vial's own label is a seller's claim, not a source.
Mixing a vial: a worked example
An arithmetic example, not a recommendation: a 5 mg vial mixed with 2 mL of bacteriostatic water holds 2,500 mcg per mL, so every 10 units on a U-100 insulin syringe hold 250 mcg. 0.56 mg, the “Eotaxin-high advanced pancreatic cancer, KG4/2015 phase 3 (with gemcitabine and capecitabine)” row is 22.4 units (0.224 mL). If your vial or water differ, the numbers change: use the reconstitution calculator.
Source: dose: Used in human trials, PMID 37903909 (Dosing Data below); vial and water: the calculator's default example, not a vial size we have a source for.
Storage before and after mixing
Unknown: no label or published stability study on file says how to store Tertomotide, before or after mixing. The mixing guide sets out the general rules, with their sources: keep a mixed vial in the fridge, and use it promptly, as the bacteriostatic water label says of any drug dissolved in it. The 28 days often quoted is the limit for an opened multiple-dose vial from a manufacturer, an outer limit set for sterility, not a time a mixed solution has been shown to keep. Nobody has published how long Tertomotide stays intact once mixed.
How it is taken
As it was given in human studies: Injection (route not stated in the abstract) (Days 1, 3 and 5, once in weeks 2–4 and 6, then monthly; Eotaxin-high advanced pancreatic cancer, KG4/2015 phase 3 (with gemcitabine and capecitabine)); Intradermal (Days 1, 3 and 5, then once in weeks 2–4, then repeated; Advanced pancreatic cancer, TeloVac phase 3 (no survival benefit)); Subcutaneous (Weekly for 4 weeks, then every 2 weeks; Moderate-to-severe Alzheimer's disease, phase 2 (effective dose)).
For injection technique, sites and needle disposal, see the mixing guide.
Source: Used in human trials: the route and frequency of each row in Dosing Data below.
What to expect, and when
How long it stays in the body: not established by a measurement cited on this entry.
How long the doses were given: Eotaxin-high advanced pancreatic cancer, KG4/2015 phase 3 (with gemcitabine and capecitabine): Alongside chemotherapy; Advanced pancreatic cancer, TeloVac phase 3 (no survival benefit): With or after chemotherapy; Moderate-to-severe Alzheimer's disease, phase 2 (effective dose): 24 weeks.
When effects appear: unknown; no source on this page gives a time to effect for Tertomotide. Results reported in the studies are under Published Research.
Source: Used in human trials, the duration of each row in Dosing Data below.
Side effects, and when to stop or get help
From the Side Effects section: Mild vaccine-related effects, grade I-II, with gemcitabine (PMID 24919654); Severe adverse events no more common than with chemotherapy alone in pancreatic cancer (PMIDs 24954781, 37903909); Adverse events similar to placebo in the Alzheimer's and BPH trials (PMIDs 33771205, 29633507); Disease progression in one of six lymphoma patients, which the authors flagged as a safety concern (PMID 21377838). Full list and cautions ↓
When to stop or get help: unknown; no label or trial on file sets rules for stopping Tertomotide. Treat a severe or unexpected reaction as a reason to stop and see a doctor.
Source: the Side Effects section below (“From the trials above”).
Interactions
Unknown: a PubMed search for human interaction studies of Tertomotide (reviewed 2026-10-28) found none. Unknown is not the same as safe to combine.
Every peptide's record, with its source: the interaction matrix.
Checking what you bought
Unknown: no published independent test of Tertomotide products is in our lab-results database yet, so how products sold under this name measure up is not known.
To read a certificate of analysis, paste it into the COA decoder; it checks the measured mass against Tertomotide's expected mass, 1,868.2 Da, from this entry's molecular data. Trust & Verification explains what independent testing can and cannot show.
Legal status
US: Not FDA Approved (Not approved in the US or EU: Drugs@FDA and the EMA medicines list hold no record (searched October 28, 2026)). Elsewhere: approved in South Korea (conditional approval September 15, 2014, Riavax, advanced pancreatic cancer; current status not confirmed October 29, 2026). Sport: Unsettled (S0 may apply).
Country by country ↓ · Regulatory tracker
Source: this entry's approval status and the WADA Prohibited List, as in Legal Status below.
Side Effects & Contraindications
Reported Side Effects
From the trials above.
Contraindications & Cautions
No US or EU label exists, and the Korean label was not read. These cautions follow from the evidence.
Legal Status
Tertomotide is conditionally approved in South Korea for pancreatic cancer and investigational elsewhere.
Frequently Asked Questions
?What is GV1001?
Tertomotide, a 16-amino-acid peptide taken from human telomerase reverse transcriptase. It was designed as a cancer vaccine and later found to enter cells and act on gonadotropin-releasing hormone receptors.
?Did it work against pancreatic cancer?
Not in the large UK TeloVac trial, which found no survival gain. A smaller Korean phase 3 in patients with high blood eotaxin found median survival of 11.3 against 7.5 months.
?Is it approved anywhere?
Korea gave it conditional approval for advanced pancreatic cancer in 2014 as Riavax. It is not approved in the US or the EU.
?Is it being tested for Alzheimer's disease?
Yes. A Korean phase 2 trial found 1.12 mg every two weeks slowed decline on a severe-dementia cognitive test over 24 weeks, and a phase 3 is registered.
?Why is a cancer vaccine tested in enlarged prostate?
It binds gonadotropin-releasing hormone receptors and lowered testosterone in mice; in men with BPH it improved urinary symptoms in phase 2 and matched finasteride on symptoms in phase 3.
References
- [other] PubChem CID 56843375, Tertomotide: formula C85H146N26O21, molecular weight 1868.2. Read October 28, 2026. https://pubchem.ncbi.nlm.nih.gov/compound/56843375
- [registry] ClinicalTrials.gov API v2, read October 28, 2026: NCT05189210 (phase 2, Alzheimer's disease, completed); NCT05303701 (phase 3, Alzheimer's disease, not yet recruiting); NCT02854072 (phase 3, pancreatic cancer).
- [other] ChEMBL CHEMBL2108308, tertomotide (synonyms include GV1001): maximum clinical phase 3 in the ChEMBL molecule record, read October 2, 2026 (the Registry's ChEMBL harvest). https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108308/
- [other] Jo JH, et al., KG4/2015 trial report, Br J Cancer 2024 (full text, Methods, PMC10781743): Riavax (GV1001) received conditional new-drug approval from Korea's Ministry of Food and Drug Safety on September 15, 2014 for advanced pancreatic cancer. Read October 29, 2026.
- [clinical-trial] Middleton G, et al. "Gemcitabine and capecitabine with or without telomerase peptide vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer (TeloVac): an open-label, randomised, phase 3 trial." Lancet Oncol, 2014;15(8):829-40. PMID: 24954781.
- [clinical-trial] Jo JH, et al. "Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial." Br J Cancer, 2024;130(1):43-52. PMID: 37903909.
- [clinical-trial] Staff C, et al. "Telomerase (GV1001) vaccination together with gemcitabine in advanced pancreatic cancer patients." Int J Oncol, 2014;45(3):1293-303. PMID: 24919654.
- [clinical-trial] Kim S, et al. "A phase II study of chemotherapy in combination with telomerase peptide vaccine (GV1001) as second-line treatment in patients with metastatic colorectal cancer." J Cancer, 2022;13(4):1363-1369. PMID: 35281880.
- [clinical-trial] Schlapbach C, et al. "Telomerase-specific GV1001 peptide vaccination fails to induce objective tumor response in patients with cutaneous T cell lymphoma." J Dermatol Sci, 2011;62(2):75-83. PMID: 21377838.
- [pubmed] Inderberg-Suso EM, et al. "Widespread CD4+ T-cell reactivity to novel hTERT epitopes following vaccination of cancer patients with a single hTERT peptide GV1001." Oncoimmunology, 2012;1(5):670-686. PMID: 22934259.
- [clinical-trial] Koh SH, et al. "Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial." Alzheimers Res Ther, 2021;13(1):66. PMID: 33771205.
- [clinical-trial] Kwon HS, et al. "Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales." Dement Neurocogn Disord, 2023;22(3):100-108. PMID: 37545861.
- [clinical-trial] Moon KT, et al. "A randomised, placebo-controlled, multicentre, Phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia." BJU Int, 2018;122(2):283-292. PMID: 29633507.
- [clinical-trial] Shin TJ, et al. "A randomized, active-controlled, multicenter, phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia." Prostate Int, 2025;13(2):81-89. PMID: 40620871.
- [review] Kyte JA, et al. "Cancer vaccination with telomerase peptide GV1001." Expert Opin Investig Drugs, 2009;18(5):687-94. PMID: 19388882.
- [review] Shaw VE, et al. "Current status of GV1001 and other telomerase vaccination strategies in the treatment of cancer." Expert Rev Vaccines, 2010;9(9):1007-16. PMID: 20822343.
- [review] Kim H, et al. "The Telomerase-Derived Anticancer Peptide Vaccine GV1001 as an Extracellular Heat Shock Protein-Mediated Cell-Penetrating Peptide." Int J Mol Sci, 2016;17(12). PMID: 27941629.
- [review] Suk K, et al. "GV1001: repurposing a telomerase-derived peptide for neurological therapeutics." Expert Opin Investig Drugs, 2026;35(5):369-381. PMID: 42130449.
- [pubmed] Park HH, et al. "GV1001 reduces neurodegeneration and prolongs lifespan in 3xTg-AD mouse model through anti-aging effects." Aging (Albany NY), 2024;16(3):1983-2004. PMID: 38301041.
- [pubmed] Park H, et al. "GV1001 modulates neuroinflammation and improves memory and behavior through the activation of gonadotropin-releasing hormone receptors in a triple transgenic Alzheimer's disease mouse model." Brain Behav Immun, 2024;115:295-307. PMID: 37884161.
- [pubmed] Lee Y, et al. "A human telomerase reverse transcriptase-derived peptide GV1001 rescues neurodegeneration in a mouse model of Alzheimer disease." Exp Mol Med, 2026;58(6):1789-1805. PMID: 42236894.
- [pubmed] Kwon HS, et al. "Neuroprotective Effects of GV1001 in Animal Stroke Model and Neural Cells Subject to Oxygen-Glucose Deprivation/Reperfusion Injury." J Stroke, 2021;23(3):420-436. PMID: 34649386.
- [pubmed] Kim JW, et al. "Anti-cancer effect of GV1001 for prostate cancer: function as a ligand of GnRHR." Endocr Relat Cancer, 2019;26(2):147-162. PMID: 30400054.
- [pubmed] Piao M, et al. "The Cell-Penetrating Peptide GV1001 Enhances Bone Formation via Pin1-Mediated Augmentation of Runx2 and Osterix Stability." Biomolecules, 2024;14(7). PMID: 39062525.
- [pubmed] Park HH, et al. "Novel vaccine peptide GV1001 effectively blocks β-amyloid toxicity by mimicking the extra-telomeric functions of human telomerase reverse transcriptase." Neurobiol Aging, 2014;35(6):1255-74. PMID: 24439482.
Sources & Citations
Studies were read from their PubMed abstracts on October 29, 2026. Korea's 2014 conditional approval is from the full text of the KG4/2015 trial report (PMC10781743), read October 29, 2026; US, EU and registry status from Drugs@FDA (openFDA), the EMA list and ClinicalTrials.gov, read October 28, 2026. The formula is PubChem's. Grey Peptides sells nothing and links to no vendor.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.