Tertomotide (GV1001)_Dosage, benefits & legal status
Also known as GV1001, GV-1001, GV 1001, Riavax, PrimoVax, tertomotide hydrochloride, telomerase peptide vaccine GV1001
A 16-amino-acid piece of telomerase, injected with GM-CSF to make T cells attack tumors. It is the rare investigational peptide that was approved, in South Korea, and then had the approval taken away.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Tertomotide (GV1001)?
Plain language first. The technical label stays, but it never stands alone.Overview
Most cancers stay alive by switching telomerase back on, and this peptide was designed to make the immune system attack the cells that do. The pancreatic cancer results split in two: a 1,062-patient UK trial found no survival gain, with one vaccine arm trending worse (6.9 against 7.9 months), while a 148-patient Korean trial that put only patients with high serum eotaxin in the vaccine arm found 11.3 against 7.5 months. South Korea approved it on that basis in 2014 and canceled the approval in 2020 when the confirming report was not filed, so nothing is approved anywhere now. The lead program today is progressive supranuclear palsy, where a 78-patient trial missed its primary endpoint and the higher dose worsened more than placebo.
Tertomotide is the 16-residue fragment of human telomerase reverse transcriptase spanning residues 611 to 626, built as a promiscuously HLA class II-binding T-cell epitope and given with GM-CSF into the skin in its cancer programs. In its later brain and prostate programs it is injected with no adjuvant, under the skin in the brain trials and into the skin in the prostate trials, and the reported action there is not immune at all: it binds the gonadotropin-releasing hormone receptor, although no affinity figure has been published. GemVax & KAEL owns it, Samsung Pharm holds the Korean rights, and the clinical drug substance is the hydrochloride.
What it's used for
Nothing is approved. It is given in clinical trials, mainly for progressive supranuclear palsy, and to a small number of Korean patients under named-patient permissions.
How does Tertomotide (GV1001) work?
What it does in the body, and where.Tertomotide is a short piece of telomerase, the enzyme almost every tumor switches back on, used as a flag to point the immune system at the cells carrying it.
- 01Calling in the cells that teachIn the cancer trials GM-CSF goes into the same patch of skin 5 to 15 minutes before the peptide. It pulls dendritic cells to the site and switches them on, so there is something waiting to pick the fragment up.
- 02Telomerase as a targetThe fragment is loaded onto MHC class II and reported to bind promiscuously across many HLA class II types. That breadth is what allows one peptide to be used in an unselected population. Helper T cells specific for hTERT 611 to 626 expand, and cytotoxic T cells follow. Tumor cells overexpress telomerase while most adult cells keep it switched off, so the target is comparatively specific.
- 03A second action that is not immune at allIn the brain and prostate programs it is given alone, and the reported mechanism is receptor binding: it binds the gonadotropin-releasing hormone receptor, and blocking that receptor removed its protection against amyloid beta in cells. In Alzheimer's model mice it lowered amyloid beta 42, BACE and phospho-tau, and it crosses the blood-brain barrier in mice. No binding affinity figure has been published for any of this.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Pancreatic cancer, the UK phase 3
tested-and-failed- Human trialTeloVac randomized 1,062 patients: median overall survival 7.9 months on chemotherapy alone, 6.9 months with sequential GV1001 and 8.4 months with concurrent GV1001 (overall p=0.11).
- No dataThe sequential arm trended worse than chemotherapy alone (HR 1.19, p=0.05), so this is not a neutral result.
Pancreatic cancer, the Korean phase 3
Investigational- Human trialKG4/2015 randomized 148, assigning only patients with serum eotaxin above 81.02 pg/mL to GV1001 and adding 37 eotaxin-low patients to the control arm: overall survival 11.3 against 7.5 months (p=0.021), time to progression 7.3 against 4.5 months (p=0.021).
- Human trialResponse rates were essentially the same (26.7% against 27.4%, p=0.920), the survival gain came without more tumor shrinkage, and the paper reports no hazard ratio.
- RegulatoryThis trial was the condition on the Korean approval. Its report was not filed by the deadline and the approval was canceled in 2020.
Alzheimer's disease
Investigational- Human trial96 patients with moderate-to-severe disease on donepezil: the Severe Impairment Battery favored 1.12 mg by 6.6 points at week 24 (p=0.027), and by 7.1 points in the per-protocol set (p=0.018).
- Human trialThe 0.56 mg arm missed, and the daily-living, dementia-rating, MMSE and global scores did not separate at either dose.
- No dataNo pharmacokinetic profile could be built because blood concentrations were extremely low.
Enlarged prostate
tested-and-failed- Human trialThe 423-patient phase 3 at 23 Korean sites tested superiority over finasteride 5 mg and did not show it: symptom scores fell 4.78 points at 0.56 mg, 4.99 at 1.12 mg and 5.51 on finasteride.
- Human trialErectile function scores fell on finasteride and not on the peptide,.
Progressive supranuclear palsy
Investigational- Human trialThe 78-patient phase 2a missed its primary endpoint. Posted results give the 24-week change in the PSP Rating Scale as +4.10 on placebo, +2.14 at 0.56 mg and +6.46 at 1.12 mg, so the higher dose worsened more than placebo.
- Human trialSerious adverse events were 3 of 24 on placebo, 2 of 24 at 0.56 mg and 5 of 28 at 1.12 mg, with no deaths.
- No dataThe 72-week extension has no placebo arm. The company compared 5.61 points of worsening at 72 weeks in the 0.56 mg group, in the Richardson syndrome subtype only, against 10.66 points over 52 weeks in an external control built by matching-adjusted indirect comparison from three published placebo arms (p<0.0001), an indirect comparison over a longer follow-up rather than a randomized one.
The most repeated error is that GV1001 is approved in South Korea. It held a conditional approval from September 15, 2014, with marketing approval passing to Samsung Pharm in April 2015, and the MFDS canceled it on August 25, 2020; nothing is approved anywhere now. The second is reporting one pancreatic phase 3 when there are two with opposite results: TeloVac found no survival gain, and the Korean KG4/2015, a trial that assigned only eotaxin-high patients to the peptide while adding 37 eotaxin-low patients to its control arm, found 11.3 against 7.5 months. TeloVac is often quoted at 1,110 patients, the estimate still shown on its registry record, and as running at 45 or 52 centers; the published paper gives 1,062 randomized of 1,572 screened at 51 UK hospitals. It is usually summarized as not improving survival, and that is generous: the sequential arm trended worse than chemotherapy alone (6.9 against 7.9 months, HR 1.19, p=0.05). Coverage of the progressive supranuclear palsy phase 2a emphasizes the 0.56 mg arm worsening 48% less than placebo and an external-control comparison at p<0.0001; the posted results show the primary endpoint missed and the 1.12 mg arm worsening more than placebo (+6.46 against +4.10). The hTERT region is reported as 616 to 626, impossible for a 16-residue peptide,; residues 611 to 626 is the figure used by the NCI and the discovery group. The GM-CSF dose gets transposed: 30 micrograms in the 2006 dose-escalation study, 75 micrograms in both phase 3 trials. It is also called a telomerase activator or an anti-aging peptide, when it was built as an immunogen against telomerase-expressing cells, and the one report of raised telomerase activity is in mice. Ownership is sometimes attributed to Enzychem; no link between that company and this peptide turns up. Unusually for a well-known peptide, a targeted search in October 2026 turned up no research-peptide seller listing it at all.
The published record
Papers and trials about Tertomotide (GV1001)
75 papers tagged human · 41 not reviews or lab · 11 clinical trial publications
18 registered trials · 1 with posted results
Furthest stage reached: Phase 3, completed, no results posted
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Tertomotide (GV1001)
Evidence
Investigational
Category
Immune support
Common vial
Varies
Half-life
Not established
How much, and do you cycle it?
The range, and whether you take breaks.0.56 to 1.12 mg per dose (phase 2a trial), weekly for 4 weeks, then every 2 weeks. A fixed 24-week course, with boosters in the cancer trials Trial dose
Every trial has used a set course rather than open-ended dosing: a short run of closely spaced injections to prime the response, then spaced boosters. The cancer trials continued monthly or every 6 months, the brain trials stopped at week 24 and offered an extension.
Not establishedNo figure
No published human half-life exists. In the Alzheimer's phase 2 no profile could be obtained at all because blood concentrations were extremely low. A review of the compound gives an in vivo half-life of about 30 minutes without naming a species, and notes that no terminal half-life, peak time, bioavailability or clearance figure has been documented. A dedicated single- and multiple-dose study in 59 healthy subjects finished on August 25, 2025 and measured all of these; its results have not been located. Metabolism and route of elimination have never been described.
Source: Koh SH et al., Alzheimer's Research & Therapy 2021, section on pharmacokinetics
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How is it given?
Dosing context and source notes.Given in hospital from a prepared product, so there is nothing to mix.
Trial range: 0.56 up to 1.12 mg per dose. ClinicalTrials.gov, progressive supranuclear palsy phase 2a (NCT05819658)
Injected into the skin in the cancer and prostate trials and under the skin in the brain trials. Across every study the dose has run from 0.112 mg to 4.48 mg: the 2006 phase 1/2 in pancreatic cancer compared 0.112, 0.56 and 1.87 mg, both pancreatic phase 3 trials used 0.56 mg, the prostate trials used 0.4, 0.56 or 1.12 mg, the Alzheimer's and progressive supranuclear palsy trials used 0.56 or 1.12 mg, and a healthy-volunteer study went up to 4.48 mg. The 0.56 mg standard comes from the 2006 trial, where the middle of three doses gave the longest median survival. In the cancer trials every injection was paired with GM-CSF at the same site, 30 micrograms in the 2006 study and 75 micrograms in both phase 3 trials; the Alzheimer's, prostate and progressive supranuclear palsy trials gave the peptide alone, with no adjuvant, so the word vaccine does not fit those programs. The usual schedule is weekly for 4 weeks, then every 2 weeks to week 24, with monthly or 6-monthly boosters in the cancer trials. How it is supplied has never been published, no renal or hepatic adjustment data exist, and it is not sold anywhere, so the calculator starts with an empty dose field.
How do you store it?
Before mixing, and after.Given in a hospital or trial clinic, so the pharmacy stores it.
Tertomotide (GV1001) is prepared and given by hospital, clinic or trial staff, following the product label or the trial protocol. Some products like this arrive ready to use and others are mixed just before the dose, often with hours rather than weeks of shelf life once prepared. It is not a medicine people store at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 44% charged residues, 56% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- No product is approved anywhere, so there is no label and no official list of contraindications
- Not studied in pregnancy or while breastfeeding: no data have been published
- Not studied in children; every trial has enrolled adults
- Not available outside a trial, apart from Korean named-patient permissions for fewer than 25 people with progressive supranuclear palsy
Stop and get help
- An injection-site reaction that keeps spreading or hardening: all 48 patients in the phase 1/2 pancreatic trial developed redness or hardening where the peptide went in
- Fever, chills or persistent nausea after a dose, the drug-related effects recorded in that trial (nausea 12%, chills 10%, fever 2%)
Common effects
- Injection-site redness or hardening in all 48 patients in the phase 1/2 pancreatic trial, with drug-related nausea 12%, chills 10%, pain 6%, fever 2%, fatigue 2% and vomiting 2%
- In the 96-patient Alzheimer's phase 2, adverse event rates were similar across the three groups, and both severe events happened in the placebo arm
- In the progressive supranuclear palsy phase 2a, serious adverse events occurred in 3 of 24 on placebo, 2 of 24 at 0.56 mg and 5 of 28 at 1.12 mg, with no deaths
- Added to gemcitabine and capecitabine, grade 3 or worse events were 77.3% against 73.1% on chemotherapy alone (p=0.562), almost all attributed to the chemotherapy
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Tertomotide (GV1001) approved?
And where the numbers on this page come from.No. Tertomotide (GV1001) is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteInto the skin (intradermal), or under the skin
- Checked21 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA GSRS substance record, tertomotide (UNII 55R7RG342O)NCI Thesaurus concept C62756Middleton G et al., Lancet Oncology 2014;15:829-840 (TeloVac)Jo JH et al., British Journal of Cancer 2024;130:43-52 (KG4/2015)Bernhardt SL et al., British Journal of Cancer 2006;95:1474-1482Koh SH et al., Alzheimer's Research & Therapy 2021;13:66ClinicalTrials.gov, progressive supranuclear palsy phase 2a (NCT05819658)ADDF Cognitive Vitality report, tertomotide (GV1001)Kormedi, report on the Riavax approval historyDailyPharm, report on the Riavax cancellationDailyPharm, report on the prostate phase 3MTN, report on the current program statusFierce Biotech, report on the phase 2a resultKorea Biomedical Review, GemVax & KAEL and GV1001
What has happened recently
The only approval tertomotide has ever held was in South Korea, and it no longer exists. The Ministry of Food and Drug Safety granted GemVax & KAEL a conditional approval for Riavax injection on September 15, 2014, for locally advanced or metastatic pancreatic cancer in patients whose serum eotaxin was above 81.02 pg/mL, described at the time as Korea's 21st domestically developed new drug; the marketing approval passed to Samsung Pharm in April 2015, once manufacturing was in place. The condition attached to it was to file the clinical study report for the 148-patient phase 3 by March 12, 2020. The report was not filed, and the MFDS canceled the approval on its own initiative on August 25, 2020. Samsung Pharm said it would seek an injunction against the cancellation; the approval was not restored, nothing had been refiled by August 2022, and the pancreatic indication no longer appears among the active programs. There has never been a US marketing application. For progressive supranuclear palsy the FDA granted orphan drug designation and then fast track designation in May 2025, the latter on May 7, 2025. GemVax reported on May 29, 2025 that the EMA had granted an orphan designation as well, a claim resting on the company's own announcement rather than a retrieved register entry. The MFDS separately permitted treatment use in 2 patients with COVID-19 on April 3, 2020, and in 2 to fewer than 25 patients with progressive supranuclear palsy on May 7, 2025, with all 24 available places now filled, so that people from the Korean phase 2 could keep dosing; both are named-patient permissions, not marketing authorizations. Samsung Pharm filed a phase 3 protocol amendment for that disease in July 2026, withdrew and resubmitted it on September 28, 2026 alongside an adaptive phase 2b/3 design, and a Korean conditional-approval review is pending. The peptide originated in the 1990s with Gustav Gaudernack at the Norwegian Radium Hospital in Oslo, passed from GemVax AS to KAEL-GemVax in 2008, and is now owned by GemVax & KAEL.
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What else is like Tertomotide (GV1001)?
Others in Immune support, side by side.If you're weighing Tertomotide (GV1001), it's worth reading Darobactin A, Thymalin, and Vilon in the same class.
A 16-amino-acid piece of telomerase, injected with GM-CSF to make T cells attack tumors. It is the rare investigational peptide that was approved, in South Korea, and then had the approval taken away.
- Dose
- 0.56 to 1.12 mg per dose (phase 2a trial)
- How often
- Weekly for 4 weeks, then every 2 weeks
Seven amino acids stitched into two fused rings by bacteria that live inside insect-killing nematodes. It blocks the machine that builds the outer wall of Gram-negative bacteria, a target nothing in the clinic hits.
- Dose
- No human dose exists: no person has received it
- How often
- Not applicable
A thymus peptide taken in courses to refresh immune function and aging.
- Dose
- 5 up to 10 mg per day (start low, increase slowly)
- How often
- 10-day courses
A tiny bioregulator taken in courses for immunity and aging, with thin evidence.
- Dose
- Varies (course-based)
- How often
- Courses
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- FDA GSRS substance record, tertomotide (UNII 55R7RG342O)(2026)Sequence EARPALLTSRLRFIPK, 16 residues, no modifications; C85H146N26O21, MW 1870.0; CAS 915019-08-8; INN list 8929; salt record for the hydrochloride (UNII EBE6EA8IZM).
- NCI Thesaurus concept C62756(2026)Defines tertomotide as the 16-residue hTERT 611 to 626 fragment; synonyms GV1001 and PrimoVax.
- Middleton G et al., Lancet Oncology 2014;15:829-840 (TeloVac)(2014)1,062 of 1,572 screened randomized at 51 UK hospitals: median overall survival 7.9 months on chemotherapy alone, 6.9 months sequential (HR 1.19, p=0.05) and 8.4 months concurrent (HR 1.05, p=0.64); overall p=0.11.
- Jo JH et al., British Journal of Cancer 2024;130:43-52 (KG4/2015)(2024)148 patients, the 75 on GV1001 all with serum eotaxin above 81.02 pg/mL and the 73 controls including 37 eotaxin-low patients: overall survival 11.3 against 7.5 months (p=0.021), time to progression 7.3 against 4.5 months, response rate 26.7% against 27.4%; no hazard ratio reported.
- Bernhardt SL et al., British Journal of Cancer 2006;95:1474-1482(2006)48 patients at 0.112, 0.56 and 1.87 mg with GM-CSF 30 micrograms: immune response in 24 of 38 evaluable, median survival 119, 260 and 153 days; all 48 had injection-site reactions.
- Koh SH et al., Alzheimer's Research & Therapy 2021;13:66(2021)96 patients: Severe Impairment Battery difference 6.6 points at 1.12 mg against placebo at week 24 (p=0.027); 0.56 mg not significant; no pharmacokinetic profile obtainable because blood levels were extremely low.
- ClinicalTrials.gov, progressive supranuclear palsy phase 2a (NCT05819658)(2026)Results posted February 10, 2026: PSP Rating Scale change at 24 weeks +4.10 on placebo, +2.14 at 0.56 mg and +6.46 at 1.12 mg; serious adverse events 3 of 24, 2 of 24 and 5 of 28; no deaths.
- ADDF Cognitive Vitality report, tertomotide (GV1001)(2025)Trial inventory, gonadotropin-releasing hormone receptor binding, an in vivo half-life of about 30 minutes with no terminal figure, FDA orphan and fast track for progressive supranuclear palsy, and the prostate phase 2 and 3 numbers.
- Kormedi, report on the Riavax approval history(2022)MFDS conditional approval on September 15, 2014; marketing approval to Samsung Pharm in April 2015; cancellation on August 25, 2020 for non-submission; nothing refiled as of August 2022.
- DailyPharm, report on the Riavax cancellation(2020)The MFDS canceled the approval because the phase 3 report was not submitted by the March 12, 2020 deadline; Samsung Pharm said it would seek an injunction.
- DailyPharm, report on the prostate phase 3(2023)423 patients at 23 Korean sites: IPSS change -4.78 at 0.56 mg, -4.99 at 1.12 mg and -5.51 on finasteride 5 mg, so superiority was not shown.
- MTN, report on the current program status(2026)Adaptive phase 2b/3 for progressive supranuclear palsy resubmitted to the MFDS on September 28, 2026; Korean Alzheimer's phase 3 filed in 2022 and still not enrolling; pancreatic indication absent from the active programs.
- Fierce Biotech, report on the phase 2a result(2024)The 78-patient trial at 5 Korean centers missed its primary endpoint; the 0.56 mg arm's smaller worsening was not statistically significant.
- Korea Biomedical Review, GemVax & KAEL and GV1001(2018)Origin with Gustav Gaudernack at the Norwegian Radium Hospital; GemVax AS ran the early European trials; KAEL-GemVax acquired the rights in 2008; prostate phase 2 in 161 patients.
Beyond these, 104 records are indexed. Browse the records