Drugs / Glasdegib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute megakaryoblastic leukemia in adult 1 milestone | |||||
| Filed | US (FDA) | — | acute megakaryoblastic leukemia in adult | 2018-06-27 | “accepted the company’s New Drug Application and granted Priority Review designation for glasdegib” pfizer.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Daurismo | — | 2020-06-26 | europa.eu ↗ |
| Approved | US (FDA) | DAURISMO | — | 2018-11-21 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT04655391 | Jun 2022 → Dec 2023 | acute myeloid leukemia | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT03627754 | Nov 2018 → Apr 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03596567 | May → Aug 2018 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03270878 | Sep → Oct 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03162900 | Jun → Sep 2017 | — | Pfizer | Completed | Met primary |
| Phase 1 | NCT02430545 | May → Jun 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02367456 | Apr 2015 → Jan 2020 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02110342 | May → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02038777 | Mar 2014 → Feb 2021 | acute myeloid leukemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01749085 | Dec 2012 → Feb 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01286467 | May 2011 → May 2012 | cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00953758 | Mar 2010 → Sep 2012 | hematopoietic and lymphoid cell neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04111497 | Dec 2019 → Aug 2023 | chronic graft versus host disease, fasciitis | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03466450 | Mar 2018 → Nov 2023 | glioblastoma | Grupo Español de Investigación en Neurooncología | Completed | No outcome recorded |
| Phase 1/2 | NCT03415867 | Jan 2018 → Jan 2022 | chronic graft versus host disease | Grupo Espanol de trasplantes hematopoyeticos y terapia celular | Unknown | No outcome recorded |
| Phase 1/2 | NCT03390296 | Dec 2017 → Feb 2022 | acute myeloid leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT04231851 | Feb 2020 → Jun 2024 overdue | acute myeloid leukemia with multilineage dysplasia, therapy related acute myeloid leukemia and myelodysplastic syndrome | University of California, Irvine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04051996 | Dec 2019 → Jun 2020 | acute myeloid leukemia | Yale University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03226418 | Jul 2017 → Mar 2024 | therapy related acute myeloid leukemia and myelodysplastic syndrome | University of Nebraska | Completed | No outcome recorded |
| Phase 2 | NCT02226172 | Oct 2014 → Dec 2016 | myelofibrosis | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT01842646 | Aug 2013 → Jan 2016 | chronic myelomonocytic leukemia, myelodysplastic syndrome | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01841333 | Apr 2013 → May 2019 | acute myeloid leukemia | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT01546038 | Jun 2012 → Jan 2017 | acute myeloid leukemia | Pfizer | Completed | Met primary |
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT06713837 | Feb 2025 → Jan 2028 expected | acute myeloid leukemia | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Recruiting | No outcome recorded |
| Phase 3 | NCT04842604 | May 2021 → Dec 2022 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04093505 | Apr 2021 → Jun 2022 | acute myeloid leukemia | University Hospital Heidelberg | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT03416179 | Apr 2018 → Jun 2020 | acute myeloid leukemia | Pfizer | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-06-30 | Pfizer | Regulatory European Commission Approves DAURISMO™ (glasdegib) for Certain Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Commission approved DAURISMO™ (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed (de novo or secondary) acute myeloid leukemia (AML) in adult patients who are not candidates for standard chemotherapy. |
| 2018-11-21 | Pfizer | Regulatory U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option pfizer.com ↗ |
| 2018-06-27 | Pfizer | Regulatory U.S. FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia pfizer.com ↗
the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib |
| 2016-12-03 | Pfizer | Results New Phase 2 Results Show Investigational Compound Glasdegib Improved Overall Survival in Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome pfizer.com ↗ |
All press releases naming this drug 4 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | glasdegib | “the novel Hedgehog pathway Smoothened inhibitor glasdegib (PF-04449913)” PMID 29463550 ↗ Feb 201820“PF-04449913 (GLASDEGIB), an oral Hedgehog inhibitor” NCT02038777 ↗ “Glasdegib+low dose cytarabine” NCT06713837 ↗ “PF-04449913 (Glasdegib)” NCT02367456 ↗ |
| Known as | Daurismo | ChEMBL registry synonym — accepted as the source's own label CHEMBL2043437 ↗ |
| Known as | GLASDEGIB MALEATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2043437 ↗ |
| Known as | PF-04449913 | “A Phase 1, Open-label, Fixed-sequence, 2-period Study In Healthy Volunteers To Investigate The Effect Of Multiple Doses Of Rifampin On Single Dose Glasdegib (Pf-04449913)...” NCT02430545 ↗15“A PHASE 1, OPEN-LABEL, SINGLE DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF GLASDEGIB (PF-04449913) IN SUBJECTS WITH IMPAIRED RENAL FUNCTION” NCT03596567 ↗ “PLASMA PHARMACOKINETICS OF GLASDEGIB (PF-04449913) IN HEALTHY SUBJECTS WITH NORMAL HEPATIC FUNCTION AND IN SUBJECTS WITH IMPAIRED HEPATIC FUNCTION” NCT03627754 ↗ “Glasdegib (PF-04449913) is an oral small-molecule inhibitor of the Hedgehog signaling pathway under development for treating myeloid malignancies.” PMID 30977980 ↗ Apr 2019 “Glasdegib (PF-04449913)” NCT02226172 ↗ “Glasdegib (Pf-04449913)” NCT04051996 ↗ |
| Known as | PF-04449913 MALEATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2043437 ↗ |
| Known as | PF-4449913 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2043437 ↗ |
| Action | Inhibit | “This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.” NCT00953758 ↗ |
| Modality | Small molecule | “This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.” NCT00953758 ↗ |
| Route | Oral | “administered as tablets PO QD continuously in 28 day cycles” NCT00953758 ↗ |
| Target | SMO | “Hedgehog pathway Smoothened inhibitor” PMID 29463550 ↗ Feb 2018 |