Asset profile
Galinpepimut-S
Vaccine
Evidence outlook · registrational
Acute Myeloid Leukemia: registrational readout pending
Entered Phase 3 on weak signal mid-stage evidence. The registry's posted readout date (2025-12) has passed without a status update. Check News for topline announcements.
NCT01266083: This was a small, single-group, open-label study of 22 participants with no placebo or active comparator and no randomization or blinding. The primary endpoint was the hard clinical measure of 3-year overall survival, reported as 47% among 19 evaluable participants, but without a control arm there was no formal treatment comparison.
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
61 competitors in this universe: 0 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 11 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Galinpepimut-S: this drug | Phase 3 | Vaccine | WT1 (Wilms Tumor-1 protein) | ||
| 3D189 | Phase 1 | Peptide | WT1 (Wilms Tumor-1 protein) | ||
| ASTX727 | Approved | Small molecule | Decitabine/cedazuridine fixed combination (DNMT + CDA inhibition) | ||
| Enasidenib | Approved | Small molecule | IDH2 | ||
| Gemtuzumab Ozogamicin | Approved | Antibody–drug conjugate | CD33 | ||
| Gilteritinib | Approved | Small molecule | FLT3 | ||
| Midostaurin | Approved | Small molecule | FLT3;KIT;PKC;PDGFR | ||
| Olutasidenib | Approved | Small molecule | Mutant IDH1 | ||
| Quizartinib | Approved | Small molecule | FLT3 | ||
| Revumenib | Approved | Small molecule | Menin | ||
| Tretinoin (Vesanoid) | Approved | Small molecule | RARA (retinoic acid receptor alpha); degrades the PML-RARA fusion oncoprotein in APL | ||
| Venetoclax | Approved | Small molecule | BCL-2 | ||
| Vyxeos | Approved | Small molecule | DNA synthesis (cytarabine, antimetabolite) / Topoisomerase II | ||
| 131I-Apamistamab | Phase 3 | Monoclonal antibody | CD45 | ||
| AK117 | Phase 3 | Monoclonal antibody | CD47 | ||
| APG-2575(Lisaftoclax ) | Phase 3 | Small molecule | BCL-2 |
…and 46 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
No upcoming readouts on record for this asset.
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.