REGN13335 History and Updates

7 events · 2023 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
7
Trial Milestones
0
Pivotal Publications
REGN13335 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20242025202620272028Trial: NCT07318597 2026-04-30 → 2028-03-08 (primary completion)Trial: NCT06137482 2023-12-06 → 2025-02-11 (primary completion)today (2026-06-01)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-01Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for REGN13335 since 2023, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Past events

2026
2025
Primary completion· ClinicalTrials.gov
A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Health
2023
Trial started· ClinicalTrials.gov
A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Health

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.