HLX15 History and Updates

9 events · 2023 – present

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

0
FDA Approvals
0
Label Revisions
9
Trial Milestones
0
Pivotal Publications
HLX15 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202320242025202620272028Trial: NCT07477587 2026-05-27 → 2027-05-25 (primary completion)Trial: NCT06895512 2025-04-30 → 2027-07-31 (primary completion)Trial: NCT05679258 2023-01-31 → 2024-03-16 (primary completion)today (2026-05-25)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-25Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for HLX15 since 2023, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07477587
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Le
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06895512
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-i

Past events

2026
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07477587
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Le
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06895512
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-i
2024
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05679258
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects
2023
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05679258
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects

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.