Drugs / Enasidenib
Enasidenib
also known as
AG-221 · CC-90007 · AG-221 mesylate · CC-90007 Free Base · Enasidenib mesilate · Enasidenib mesylat · ENASIDENIB MESYLATE · Enasidenib methanesulfonate · +1 more
Small molecule targets IDH2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | IDHIFA | — | 2020-11-24 | fda.gov ↗ |
| Approved | US (FDA) | IDHIFA | — | 2017-08-01 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02218346 Comparator | Aug → Dec 2014 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02665065 Comparator | Jun 2016 → Jun 2022 overdue | acute myeloid leukemia | Actinium Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03723057 Background | — | acute myeloid leukemia | Celgene Corporation | No longer available | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enasidenib | “Enasidenib” NCT02665065 ↗35 |
| Known as | AG-221 | “Phase 2 Trial of Enasidenib (AG-221) Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients With IDH2 Mutation” NCT03728335 ↗10“AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme.” NCT02218346 ↗ |
| Known as | AG-221 mesylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989908 ↗ |
| Known as | CC-90007 | “Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in...” NCT04310527 ↗1“AG-221 (CC-90007) Versus Conventional Care Regimens” NCT02577406 ↗ |
| Known as | CC-90007 Free Base | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989908 ↗ |
| Known as | Enasidenib mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989908 ↗ |
| Known as | Enasidenib mesylat | “Enasidenib mesylat dose escalation” NCT05282459 ↗ |
| Known as | ENASIDENIB MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989908 ↗ |
| Known as | Enasidenib methanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989908 ↗ |
| Known as | Idhifa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989908 ↗ |
| Action | Inhibit | “Enasidenib, an inhibitor of mutated IDH2 proteins, induces responses in patients with IDH2-mutated, relapsed or refractory acute myeloid leukaemia.” PMID 32145771 ↗ Mar 2020 |
| Modality | Small molecule | “Enasidenib is an oral, small-molecule inhibitor of mIDH2 proteins.” PMID 29243965 ↗ Sep 2017 |
| Route | Oral | “Enasidenib tablets administered orally every day of 28-day treatment cycles until disease progression or unacceptable toxicities.” NCT01915498 ↗ |
| Target | IDH2 | “Enasidenib (AG-221) is an allosteric inhibitor that binds to the IDH2 dimer interface and blocks the production of 2HG by IDH2 mutants9,10.” PMID 29950729 ↗ Jun 2018 |