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ION717

Phase 1

Prion Disease | Small molecule | Neurology |Ionis Pharmaceuticals, Inc.|Last Updated: Aug 26, 2026

Target and mechanism

Molecular targetPRNP
Target classGene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

ION717 · 1 trial · 1 indication

Phase 1 1
NCT06153966PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717Prion Disease
ACTIVE NOT_RECRUITING85 Analytics
PHASE1ACTIVE NOT_RECRUITING
PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717
Prion DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events.
Baseline up to Week 33

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) of ION717
on Day 1 and Week 9
Area Under the Plasma Concentration-time Curve (AUC) of ION717
on Day 1 and Week 9
Half-life (t1/2λz) of ION717 in Plasma
on Day 1 and Week 9
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ION717 + Placebo, Regimen 1EXPERIMENTALParticipants will receive multiple doses of study drug (ION717 and placebo) during the 30-week treatment period; the order of doses is blinded. Participants will then receive multiple doses of ION717 during the 142-week open-label extension period.
ION717 + Placebo, Regimen 2EXPERIMENTALParticipants will receive multiple doses of study drug (ION717 and placebo) during the 30-week treatment period; the order of doses is blinded. Participants will then receive multiple doses of ION717 during the 142-week open-label extension period.
ION717, Regimen 3EXPERIMENTALParticipants will receive multiple doses of ION717 during the 30-week treatment period and the 142-week open-label extension period.

Interventions

NameTypeDescription
ION717DRUGION717 will be administered by IT injection.
PlaceboDRUGPlacebo-matching ION717 will be administered by IT injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria * A confirmed diagnosis of probable or definite prion disease. * Early-stage prion disease at the time of Screening. * Willing to meet all study requirements, including travel to Study Center, procedures, measurements and visits. * Patients must have a caregiver who is ≥ 18 y...

Countries:United StatesAustraliaCanadaFranceGermanyIsraelItalyJapanSpain
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Recent Changes (Last 90 Days)

LOWAug 26, 2026NCT06153966lastUpdatePostDate: changed
LOWAug 26, 2026NCT06153966lastUpdatePostDate: changed
MEDIUMAug 20, 2026NCT06153966Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 20, 2026NCT06153966Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 20, 2026NCT06153966Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 20, 2026NCT06153966Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 5, 2026NCT06153966lastUpdatePostDate: changed

Frequently asked questions about ION717

What is ION717 used for?

ION717 is an investigational drug being developed for the treatment of prion disease, a rare and fatal neurodegenerative condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ION717 target?

ION717 targets the PRNP gene, which encodes the prion protein. By targeting this gene, the drug aims to reduce the production of the prion protein, which is central to the pathology of prion disease.

Who is developing ION717?

ION717 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IONS on the NASDAQ exchange.

What phase is ION717 in?

ION717 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use and is still undergoing clinical trials to assess its safety and efficacy.

What clinical trials is ION717 in?

ION717 is being studied in a Phase 1 clinical trial with the identifier NCT06153966. This trial, known as PrProfile, is assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ION717 in patients with prion disease. The trial is active but not recruiting participants.

Is ION717 the same as any other drug?

ION717 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available information.