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NeOnc's NEO100 nears 2026 glioma data after nine-year, six-slip delay

NeOnc's intranasal perillyl alcohol trial in recurrent IDH1-mutant glioma has no direct comparator in development, and its primary completion date has moved six times since 2020.

Trial NCT02704858

Executive Summary

  • NeOnc is heading toward a 2026 data readout for its intranasal perillyl alcohol program in recurrent IDH1-mutant glioma, a trial that has been running for close to a decade.
  • The primary completion date has been pushed back repeatedly since 2020, and the current 2026 guidance is itself a narrowing of an earlier full-year window, which puts execution discipline as much in focus as the underlying biology.
  • No other industry-sponsored trial targets the same mechanism in this glioma population, so the readout will be the first data point on this specific approach rather than a comparison against a rival program.
  • The trial is early-phase and not designed for registration, so its most direct contribution will be to determine whether an intranasal, nose-to-brain delivery strategy can produce a signal the company's later-stage plans can build on.

The catalyst

NeOnc Technologies Holdings said it expects topline data during 2026 from the Phase 2a portion of its trial evaluating NEO100 in recurrent or progressive Grade III or IV IDH1-mutant glioma. The trial, registered as NCT02704858, is testing an intranasal formulation of perillyl alcohol designed to reach the brain directly through the nasal passage rather than through systemic circulation. The company's most recent disclosure narrowed its guidance to 2026 after earlier windows had pointed to the first half of the year and then a May completion. NeOnc's+1NeOnc's Global Expansion Accelerates After Abu Dhabi IND Approval for NEO212Jun 17, 2026Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated GliomaNCT02704858

A nine-year trial

The study first posted on ClinicalTrials.gov in March 2016 and started enrolling in August 2017. Its primary completion date has moved six separate times: from June 2020 to June 2021, then to June 2022, June 2024, December 2024, October 2025, and now March 30, 2026. Enrollment target rose from 43 to 49 patients in 2020, a change that predates the recent completion-date shifts and does not itself signal distress. The trial remains listed as Recruiting, with a planned enrollment of 49 patients across sites in the United States. NCT02704858Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated GliomaNCT02704858

The prior signal

NeOnc has said prior clinical observations from the program showed tumor remission in approximately 24% of recurrent glioblastoma patients treated with NEO100, a figure the company has cited while cautioning that larger studies will determine clinical significance. No primary endpoint, effect-size threshold, or statistical result has posted for the current Phase 2a analysis on ClinicalTrials.gov. The 2026 topline readout is the event that will test whether that early remission signal holds in the full IDH1-mutant analysis population. NeOnc'sNeOnc's Global Expansion Accelerates After Abu Dhabi IND Approval for NEO212Jun 17, 2026

The competitive frame

No industry-sponsored trial anywhere pairs NEO100's Protein Farnesyltransferase and Ras mechanism with this glioma population, making it the only asset in clinical testing on that specific target-indication combination. The nearest trials in the broader glioma field, including IDH1-targeted small molecules like vorasidenib and safusidenib and other modality classes such as gene therapy and tumor-treating fields devices, share the indication but not the mechanism. Field activity data show only 1 recent trial against 21 older trials studying this target, a decline that reflects a lightly populated mechanism rather than one where multiple sponsors have already tested and failed.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.