INQOVI (cedazuridine)
INQOVI is indicated for the treatment of Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia with Ringed Sideroblasts; Refractory Anemia with Excess Blasts; Chronic Myelomonocytic Leukemia.
How INQOVI Works
Inqovi combines decitabine, a nucleoside metabolic inhibitor, with cedazuridine, a cytidine deaminase (CDA) inhibitor. Decitabine is incorporated into DNA where it inhibits DNA methyltransferase, resulting in DNA hypomethylation. This restores normal function to genes critical for cellular differentiation and proliferation, ultimately inducing apoptosis in rapidly dividing cancer cells. Because decitabine is rapidly degraded by CDA in the gastrointestinal tract and liver, the addition of cedazuridine inhibits this metabolism, significantly increasing the oral bioavailability and systemic exposure of decitabine.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-07-07
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
INQOVI Approval History
What INQOVI Treats
5 indicationsINQOVI is approved for 5 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelodysplastic Syndromes
- Refractory Anemia
- Refractory Anemia with Ringed Sideroblasts
- Refractory Anemia with Excess Blasts
- Chronic Myelomonocytic Leukemia
INQOVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INQOVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INQOVI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to INQOVI
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04256317 | ASTX030-01 2024-515098-93 | Ph 2, Ph 3 | recruiting | A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) |
| NCT04980404 | 21-214 | Ph 1 | active not recruiting | Inqovi Maintenance Therapy in Myeloid Neoplasms |
| NCT03875287 | J18115 IRB00182038, ASTX727 | Ph 1 | active not recruiting | Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors |
| NCT05799079 results posted | VICCHEM2163 | Ph 2 | terminated | Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant |
| NCT05918055 results posted | 10001541 001541-C | Ph 1, Ph 2 | terminated | Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes |
| NCT04953923 | E7727-02 | Ph 1 | completed | Thorough QT Assessment of Cedazuridine in Healthy Subjects |
| NCT04985656 PEVOBINE | Pevonedistat-2003 | Ph 2 | withdrawn | A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INQOVI FDA Label Details
Indications & Usage
FDA Label (PDF)INQOVI is indicated for the treatment of Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia with Ringed Sideroblasts; Refractory Anemia with Excess Blasts; Chronic Myelomonocytic Leukemia.
INQOVI Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for INQOVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 11 active patents
Trial Analysis
- • 7 total trials
- • Stage: Stable
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment