Landmark 152 · Trial in people
CDNF Phase 1/2
Safe enough in 17 people, but symptoms did not improve significantly. The company has moved to a copy of the protein given by injection under the skin.
In short
CDNF, a protein that protects dopamine cells in animals, was infused into the putamen of 17 people; it was safe enough but showed no significant symptom benefit, and its developer has since moved to a subcutaneous peptide copy, HER-096.
- What it is
- Trial in people
- Outcome
- Replaced by a newer approach
- When
- 2017–2023
- Size
- 17 people · Phase 1/2
- Approach
- Replace or repair what's lost
- Research lane
- Growth factors
- Trial registry
- NCT03295786
- 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
Herantis Pharma (Finland), with Renishaw (the infusion device) as registry collaborator. Paper: Huttunen and colleagues, Movement Disorders 2023. Sites in Finland and Sweden.
What happened
- CDNF (cerebral dopamine neurotrophic factor) is a protein that helps cells cope with stress in their protein-folding machinery. It protected dopamine neurons and improved movement in animal models.
- Phase 1/2 (NCT03295786, started 26 Sep 2017; completed Dec 2019). 17 people aged 35–75 with moderate Parkinson's (5–15 years of disease, Hoehn and Yahr 3 or less off medication) were randomised to placebo (6), 0.4 mg (6) or 1.2 mg CDNF (5). The protein was infused monthly into the putamen through a bone-anchored port and four catheters, for six months, then all had active drug for six months.
- Results. The main goals, safety and tolerability of CDNF and of the delivery system, were met. Drug-related adverse events were mild to moderate and did not differ from placebo. Severe adverse events were linked to the infusion procedure and did not recur after the procedure was changed. There were no significant differences between placebo and CDNF in the symptom measures (secondary endpoints) over the main or extension study. The authors reported possible signs of biological response, from dopamine-transporter PET (exploratory), in individual patients.
- What came next. Herantis's current lead is HER-096, a small peptide built on CDNF's active site that is given by subcutaneous injection and designed to cross the blood-brain barrier. It completed a Phase 1b, and a Phase 2 is in preparation (August 2026 report); the company is seeking a partner and has not announced a start. No further trial of intraputamenal CDNF is registered or mentioned.
- Funder report (source sweep, Oct 2026). Parkinson's UK says it committed £1.55 million from its Parkinson's Virtual Biotech to the first clinical trial of HER-096, now under way in Finland, after ending support for surgically delivered GDNF in 2024.
Why it moved us toward a cure
GDNF, in landmark 39, showed that delivering a growth factor to the putamen is technically possible but clinically uncertain. CDNF tested a different protein through the same route. The tiny trial could not settle efficacy, and the brain surgery needed to deliver the protein is the problem its successor is meant to avoid.
Outcome
Superseded. The company has set aside the brain-infused protein in favour of a peptide that does not need surgery (a 2023 expert workshop on growth factors also reviewed this trial). Whether HER-096 does what CDNF could not is untested in efficacy terms.
Sources
- Huttunen et al., Mov Disord 2023;38:1209-1222, DOI 10.1002/mds.29426, PMID 37212361 (abstract via Europe PMC)
- ClinicalTrials.gov NCT03295786 (API, 19 Oct 2026)
- Herantis topline release, Feb 2020 (via Cision) · Cure Parkinson's summary
- Herantis 1H 2026 report release, 20 Aug 2026 · Edison Group note on HER-096
- Barker et al., growth-factor workshop, J Parkinsons Dis 2024;14:1659-1676, DOI 10.1177/1877718X241301041
- Parkinson's UK Research Roundup, 3 Feb 2025
- Not yet verified: DAT-PET numbers (only the abstract was read); the 2020 topline wording that "some serious adverse events were device-related" is consistent with the paper but the paper's counts were not read; whether Herantis formally ended intraputamenal CDNF (no statement found).
How it connects
Built on
- builds on GDNF: the growth-factor idea, from infusions to gene therapy · 2003
Led to
None recorded.