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NCT07514338: Falcon-OLE
Open Label Extension to Assess Long Term Safety and Efficacy of KL1333 in Patients With Primary Mitochondrial Disease
Phase 2 trial testing Napazimone in Mitochondrial Diseases in 140 participants. Not yet recruiting.
31 March 2029
Quick facts
| Lead sponsor | Pharming Technologies B.V. |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 9 June 2026 |
| Primary completion | 31 March 2029 |
| Estimated completion | 31 March 2029 |
Drugs / interventions tested
- Napazimone — full drug profile →
Conditions studied
- Mitochondrial Diseases — all drugs for Mitochondrial Diseases →
Sponsor
Pharming Technologies B.V. — full company profile →
Who can join
18 and older, any sex, with Mitochondrial Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to investigate if the study medicine, KL1333, is safe, well-tolerated and effective long-term in improving the symptoms of fatigue and impacts on daily living and functional capacity (physical abilities) in people with PMD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07514338
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mitochondrial Diseases
Currently open trials in the same condition.
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- NCT06573866 — Enhancement of Quality of Work And Life · NA · recruiting
- NCT06535646 — Digital Health Technology for People With Mitochondrial Disease · NA · recruiting
- NCT06504433 — The Natural History of Mitochondrial Diseases · recruiting
- NCT04322734 — Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders · recruiting
Other Pharming Technologies B.V. trials
Trials by the same sponsor.
- NCT06990529 — Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation · Phase 2 · recruiting
- NCT05693129 — Pediatric Patients Aged 1 to 6 Years With APDS · Phase 3 · active not recruiting
- NCT06249997 — An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS · Phase 3 · unknown
- NCT05438407 — Pediatric Patients Aged 4 to 11 Years With APDS · Phase 3 · active not recruiting
- NCT04912141 — Prevention of Acute Kidney Injury in Patients With NSTEMI · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07514338 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharming Technologies B.V.
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07514338.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing