Peptide Library

Human study PLS-00244

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Other design · 313 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)registry entry · NCT06373731 (ACTIVE_NOT_RECRUITING, no results posted, planned enrollment 313)

Design and participants

Design
Other design
Population
Subjects with dry age-related macular degeneration (dry AMD)
Conditions
Age Related Macular Degeneration (ARMD), Dry age-related macular degeneration
Planned enrollment (registry)
313
Enrolled
313
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • Elamipretide (intervention) · elamipretide · Elamipretide; the registry also lists elamipretide HCL as an intervention · subcutaneous injection · Not reported assigned
  • Placebo (comparator) · Placebo · placebo · subcutaneous injection · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Efficacy in dry AMD (specific measure not stated in record)

unclear outcome · patient-important

  • No results reported.

Safety

unclear outcome · safety

  • No results reported.

Pharmacokinetics

unclear outcome · surrogate

  • No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: The title states that safety is assessed. The record gives no monitoring details.

The authors concluded (paraphrased): No conclusions are available. The registration is active, not recruiting, and has no posted results.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • abstract only: The only source is a registry entry with no publication, abstract or posted results.
  • other: The record reports no outcome results, so no efficacy or safety findings can be appraised.
  • inadequate randomization: The registry fields in the record do not state whether allocation was randomized or how it was concealed.
  • inappropriate population: Participants have dry AMD, which differs from the Barth syndrome and mitochondrial myopathy populations in the claim questions.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

Where each value comes from

  • arms: NCT NCT06373731, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT06373731, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT06373731, title (study title) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT06373731, registry (enrollment field (actual)) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT06373731, registry (conditions field) · extracted by AI (automated, not verified by a person)

  • Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).