GV1001

GV1001 (Tertomotide)

Evidence & Status

  • Moderate Evidence
  • Moderate

At a Glance

An hTERT-derived peptide with mixed posted PSP trial results and separate Alzheimer’s randomized research; established PSP benefit has not been demonstrated.

Plain English

GV1001 is being studied in specific neurological diseases, not as a general memory or focus supplement. Its PSP trial results differed between dose groups and do not establish efficacy. Cell and mouse findings cannot be treated as proven effects in people.

Overview

GV1001 is a peptide derived from human telomerase reverse transcriptase (hTERT). The PSP trial registry describes a lyophilized peptide and associates tertomotide naming; differing dose-qualified labels are not interchangeable dose equivalents. Human neurological studies and PSP-relevant cell/mouse research are separate evidence layers. Neither preclinical findings nor trial registration establishes human neuroprotection, tau reduction or disease modification.

Research Summary

NCT05819658 was a completed 24-week randomized, placebo-controlled, subcutaneous Phase 2a PSP study with 78 actual participants. Its title describes double-blinding; structured registry fields report quadruple masking. Results posted February 10, 2026 report mean 24-week PSP-rating-scale changes of 4.10 with placebo, 2.14 with the lower dose and 6.46 with the higher dose, among 22, 20 and 25 completers respectively. These are mixed descriptive findings, not established PSP efficacy. Serious adverse events affected 3/24, 2/24 and 5/28 safety participants respectively; zero deaths were reported. These events are not automatically attributable to the drug. Separately, a 96-participant, 24-week Alzheimer’s randomized trial in patients already receiving donepezil found less decline on its primary cognitive endpoint with the higher GV1001 dose; most secondary endpoints were not significantly different. That trial does not establish PSP benefit. A separate PSP-relevant publication reports reduced pathological 4R tau and functional findings in cell and mouse models only; it does not demonstrate human tau reduction or disease modification.

Research Areas

  • Progressive supranuclear palsy research
  • Alzheimer’s disease research
  • Preclinical 4R tau research

Safety & Risks

Serious Risks

  • Serious adverse events occurred in all PSP trial groups, including 5/28 participants in the higher-dose safety group; drug attribution and longer-term risks are not established.

Reported Side Effects

  • Injection-site erythema and dizziness were among adverse events reported in the PSP registry; causality was not established
United States
Investigational neurological research; no approved clinical use is asserted by this record.
United Kingdom
Current authorization status not established in this record.
Australia
Current authorization status not established in this record.
Canada
Current authorization status not established in this record.

Citations & Sources