TheraRadar
Data updated: May 26, 2026

JESDUVROQ (daprodustat)

Trial Activity: Declining 1 active trials
First-in-Class
Renal Approved 2023-02-01
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

GlaxoSmithKline conducting 8 trials (80%)
5 indications explored (Moderate)
→ anaemia (9 trials)
→ anemia (1 trials)
→ renal insufficiency, chronic (1 trials)
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
Discontinued
First Approved
2023-02-01
Patent Cliff
2038

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

GSK
Active Ingredient: DAPRODUSTAT

JESDUVROQ Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2023 to 2023
Feb 2023 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What JESDUVROQ Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)
📋

Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
NCT07300111 QLG1218-301 Ph 3 not yet recruiting A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
NCT05682326 ASCEND-P results posted 214066 Ph 3 completed Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
NCT04640311 results posted 213022 Ph 1 completed Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
NCT05951192 ROQ-IT USRC-2023-001 Ph 4 completed A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease
NCT02876835 results posted 200808 2016-000542-65 Ph 3 completed Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
NCT03446612 results posted 205767 2017-002268-42 Ph 2 terminated Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)
NCT03457701 results posted 201771 Ph 2 completed Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
NCT02879305 results posted 200807 2016-000541-31 Ph 3 completed Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
NCT03029208 results posted 201410 2016-000507-86 Ph 3 completed Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
NCT03029247 results posted 205665 Ph 2 completed Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

JESDUVROQ FDA Label Details

View full patent landscape →
6 OB patents · 2 families · 78 international docs across 31 countries

JESDUVROQ Patents & Exclusivity

Latest Patent: Mar 2038
Exclusivity: Feb 2028

Patents (6 active)

US11117871 Expires Mar 13, 2038
US11649217 Expires Mar 13, 2038
US8324208 Expires Dec 11, 2028
US8815884 Expires Jun 22, 2027
US8557834 Expires Jun 22, 2027
US11643397 Expires Jun 22, 2027

Exclusivity

NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
NCE Until Feb 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for JESDUVROQ

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2038
  • • 150 active patents

Trial Analysis

  • • 10 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA216951 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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