Landmark 292 · Trial in people
TJ0113 (mitophagy inducer)
The company reports a large gain in movement scores over 12 weeks in 149 people. It is short, not yet peer reviewed, and may be symptom relief.
In short
A Chinese oral drug said to speed the clearing of damaged mitochondria cut off-medication motor scores by about 6 points more than placebo over 12 weeks in 149 people; a 300-person Phase 3 is registered, but the result is short-term and not peer-reviewed.
- What it is
- Trial in people
- Outcome
- Mixed or early results
- When
- 2024–2028
- Size
- 300 people · Phase 3
- Approach
- Help cells clean up
- Research lane
- Mitochondria & energy
- Trial registry
- NCT06596005
- Last checked
- 19 Oct 2026
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
Hangzhou PhecdaMed (drug developer); the Phase 2 was run by the Second Affiliated Hospital of Zhejiang University with six other hospitals.
What happened
- Phase 2 (NCT06596005). Randomised, quadruple-masked. 149 people with early Parkinson's, 50 on 200 mg, 48 on 400 mg and 51 on placebo, once daily for 12 weeks. Started 18 September 2024; completed September 2025; results posted 16 January 2026.
- Result (registry). Change in MDS-UPDRS part III (motor exam, off anti-Parkinson drugs for at least 12 hours): -7.06 (200 mg), -7.40 (400 mg), -0.69 (placebo). Difference from placebo at 200 mg: -6.37 points (95% CI -8.09 to -4.64), nominal p<0.0001. Serious adverse events: 2 in the 200 mg group, none in the others.
- Phase 3 (NCT07741045). Planned 300 people with early-onset Parkinson's (onset at or before age 50), 200 mg or 400 mg versus placebo (2:1 within each), 26 weeks double-blind plus 26 weeks open-label. Primary: part III change at week 26. Estimated start 3 August 2026; the record (updated 12 August 2026) still showed not yet recruiting, so the start is unconfirmed. Estimated primary completion January 2028.
- Mechanism (sponsor protocol, via search summary). It is said to bind Mcl-1 on the mitochondrial outer membrane, raise Parkin and steer it to damaged mitochondria. Animal data are in an Investigator's Brochure I could not see.
Why it moved us toward a cure
landmark 15 tied recessive Parkinson's to clearing damaged mitochondria. USP30 and PINK1 drugs are in Phase 1 (landmark 156); TJ0113 is the first mitophagy-targeting drug with a placebo-controlled result.
Outcome
Open. The benefit is large for 12 weeks and measured off medicine, so it could be symptomatic and does not show slowing. The peer-reviewed paper, the mechanism data and a Phase 3 readout are still missing.
Sources
- ClinicalTrials.gov NCT06596005 (API read 19 Oct 2026, results section)
- ClinicalTrials.gov NCT07741045
- Phase 2 protocol (sponsor) (text not readable by me; mechanism from a search summary)
- Not yet verified: mechanism and preclinical data; allowed background medicines in Phase 2; any publication; the Phase 3 start.
How it connects
Built on
- tests PINK1 and the mitophagy pathway · 2004
Led to
None recorded.