RO7568282 (TARBELA-PD, NLRP3)

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

Hoffmann-La Roche. Roche bought NLRP3 specialist Inflazome in September 2020; whether RO7568282 itself came from Inflazome is not confirmed (see What happened).

What happened

• TARBELA-PD (NCT07781644). Registered as Phase 1/2 (the title says Phase II). Randomised, double-blind, low dose, high dose or placebo, capsules. Planned 474 adults aged 40 to 85 with idiopathic Parkinson's, on stable levodopa alone for at least 2 months, with no motor complications (MDS-UPDRS part IV of 0) and Hoehn and Yahr stage 3 or less.
• Measures. Primary: time to a confirmed motor progression event on MDS-UPDRS part III. Secondary: part III change at week 104, safety, drug levels. That is a progression-style design.
• Dates. Registry (updated 21 September 2026): not yet recruiting; estimated start 30 September 2026; primary completion 15 December 2028; study end April 2032. I could not confirm that enrolment has begun.
• Earlier work. Roche's patient page for Phase 1 study BP45361 says RO7568282 is designed to block NLRP3 and "could potentially slow the progression"; it covers healthy volunteers and early Parkinson's (ages 40 to 75). No results are public.
• Inflazome. On 21 September 2020 Inflazome announced Roche would buy it for €380 million upfront (about $448 million as reported) plus milestone payments, with full rights to its clinical and preclinical oral NLRP3 inhibitors (Biospace copy of release). No source I could read names RO7568282 as an Inflazome compound; public sources link Inflazome to inzomelid and to selnoflast (see landmark 55).

Why it moved us toward a cure

Synuclein clumps switch on the NLRP3 alarm complex in microglia, and blocking it protected neurons in mice (landmark 55). VTX3232 showed in about 10 people that a brain-penetrant NLRP3 blocker lowers inflammation markers (landmark 185), but it had no control group. TARBELA-PD, with 474 people, is the first test large and long enough to ask whether such a drug slows motor decline. The terminated VENT-02 study is in landmark 291.

Outcome

Pending. No efficacy data exist. Primary completion is estimated for late 2028.

Sources

• ClinicalTrials.gov NCT07781644 (API read 19 Oct 2026)
• Roche for-patients page, TARBELA-PD · Phase 1 BP45361 page
• Not yet verified: actual start; whether RO7568282 came from Inflazome (the purchase itself is confirmed); Phase 1 size and results; the chemical class.