Study
Safety and Efficacy of Oral AV078 in Participants With Tuberous Sclerosis Complex Refractory Epilepsy (Phase 2)
Phase 2 trial will test AV078, a selective mTORC1 inhibitor, in 42 participants aged 12 and older with refractory epilepsy due to tuberous sclerosis complex. Sponsor Aeovian Pharmaceuticals. Not yet recruiting, primary completion September 2027.
NCT07680322 will randomise approximately 42 participants aged 12 and older to oral AV078 or placebo in a 5:1 ratio. AV078 is a selective small-molecule mTORC1 inhibitor under development by Aeovian Pharmaceuticals, a longevity-therapeutics company that has dosed its first phase 2 trial with this compound.
The indication here is refractory epilepsy due to tuberous sclerosis complex, not aging. TSC is driven by mTOR pathway overactivation, which is why an mTORC1 inhibitor is a rational therapy in this genetic disease.
The longevity angle is indirect: AV078 is the first selective mTORC1 inhibitor from a longevity-focused company to reach the clinic, and its safety data in humans will matter for the broader rapamycin programme. Rapamycin itself stays at evidence grade B. This trial is not evidence for rapamycin supplementation: different molecule, disease population, no aging endpoints.
No results possible yet. Registry status: not yet recruiting; planned start 1 September 2026, primary completion 1 September 2027.
Drug-industry trial in a genetic epilepsy population. Not an aging intervention. Any selective mTORC1 inhibitor safety data is worth tracking, but nothing here supports consumer rapamycin use.
registered-trial-no-results
Registered drug trial, not yet recruiting, no results. Registry record only, tier 4.
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Expected readout: Safety and seizure-outcome data after September 2027. · Decision recorded 2026-10-01
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