Data updated: Nov 8, 2026
ELIQUIS SPRINKLE (apixaban) · Bristol-Myers Squibb
Genetic Support
Trial Activity: Stable 24 active trials
Cardiovascular
Approved 2025-04-17
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
Development Insights
Bristol-Myers Squibb conducting 19 trials (17%)
144 indications explored (Broad Platform)
→ atrial fibrillation (23 trials)
→ venous thromboembolism (22 trials)
→ stroke (7 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2025-04-17
- Patent Cliff
- 2041
- Revenue
- $4.7B (Q3-2026)
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION
ELIQUIS SPRINKLE Approval History
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2026
What ELIQUIS SPRINKLE Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
ELIQUIS SPRINKLE Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
ELIQUIS SPRINKLE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Bristol-Myers Squibb's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
COBENFY
2024 TROSPIUM CHLORIDE
1 designation
AUGTYRO
2023 REPOTRECTINIB
2 designations
CAMZYOS
2022 MAVACAMTEN
3 designations
OPDUALAG
2022 NIVOLUMAB
4 designations
KRAZATI
2022 ADAGRASIB
4 designations
SOTYKTU
2022 DEUCRAVACITINIB
1 designation
ZEPOSIA
2020 OZANIMOD HYDROCHLORIDE
INREBIC
2019 FEDRATINIB HYDROCHLORIDE
2 designations
REBLOZYL
2019 LUSPATERCEPT-AAMT
4 designations
IDHIFA
2017 ENASIDENIB MESYLATE
4 designations
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Clinical Trial Registry
118 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07175428 ROXI-ATLAS | R7508-CVA-2393 | Ph 2 | recruiting | Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation |
| NCT03907046 ASPIRE | 2000026409 1U01NS106513-01A1 | Ph 3 | recruiting | Anticoagulation in ICH Survivors for Stroke Prevention and Recovery |
| NCT05757869 LIBREXIA-AF | CR109220 70033093AFL3002, 2022-501419-15-00 | Ph 3 | active not recruiting | A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation |
| NCT07015905 ROXI-APEX | R7508-DVT-24116 2025-520478-20-00, 2025 | Ph 3 | recruiting | REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults |
| NCT05735639 THRIVE | 22CX7510 ISRCTN18501431 | Ph 4 | recruiting | THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) |
| NCT07312851 | D9609C00001 2025-522513-30-00 | Ph 1 | completed | A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants |
| NCT04642430 COBRRA-AF | COBRRA-AF | Ph 4 | recruiting | COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation |
| NCT06953726 VALIANT-AF-T | 2037T 2037 | Ph 4 | recruiting | Comparing the Safety and Efficacy of Apixaban and Rivaroxaban |
| NCT07521332 APIXABAN-PK | AIMS/ERC/9853/26 | Ph 4 | recruiting | Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis |
| NCT07493304 ROXI-CAT-II | R7508-CAT-2396 2024-519299-16-00 | Ph 3 | recruiting | Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers |
| NCT06650501 DABI-SNAP | 2025-10900 500464, 2025 | Ph 4 | recruiting | Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia |
| NCT07471139 | AAAV9532 | Ph 3 | recruiting | SWITCH: Apixaban vs Vitamin K in HM3 |
| NCT04809818 results posted | LT3001-105 | Ph 1 | completed | A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects |
| NCT07434661 SAFE-HEART | A568096267900 | Ph 3 | not yet recruiting | Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR |
| NCT05171049 ASTER | ANT-007 2023-509569-19-00, CMAA868D12302 | Ph 3 | terminated | A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE |
| NCT07404345 APICATH-HD | APICATH-HD-01 | Ph 4 | not yet recruiting | Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dysfunction (APICATH-HD) |
| NCT05683808 VTE-POG | NNECOS004 | Ph 2 | recruiting | Venous Thromboembolism Prevention in Outpatients With Glioma |
| NCT06370273 TiLLI | 1009305 | Ph 3 | recruiting | Thromboprophylaxis in Lower Limb Immobilisation |
| NCT03463317 CLOSURE-AF | CLOSURE-AF-DZHK16 | Ph 4 | completed | Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy |
| NCT07237308 | 4-2025-0697 | Ph 4 | recruiting | BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis |
| NCT03266783 COBRRA results posted | COBRRA | Ph 4 | completed | Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism |
| NCT02559856 COBRRA Pilot results posted | COBRRA Pilot 20150574-01H | Ph 4 | completed | Comparison of Bleeding Risk Between Rivaroxaban and Apixaban: The Pilot Study |
| NCT07189897 | 2225826-3 | Ph 4 | recruiting | Apixaban or Enoxaparin After Head and Neck Cancer Surgery |
| NCT07160686 THROMBO-STOP | RG_25-043 NIHR165646 | Ph 3 | recruiting | Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment |
| NCT03288454 results posted | PER977-02-011 | Ph 2 | completed | Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT |
| NCT02066454 MYELAXAT | DCIC 1320 2013-003190-99 | Ph 3 | completed | Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs |
| NCT06515730 RESOLVE-AMI | RESOLVE-AMI | Ph 4 | recruiting | Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction |
| NCT03045406 CARAVAGGIO results posted | FADOI.03.2016 | Ph 3 | completed | Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer |
| NCT04007289 APIS | P170916J | Ph 3 | active not recruiting | Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension |
| NCT03080883 results posted | ACCRU-SC-1601 NCI-2017-00325, ACCRU-SC-1601 | Ph 3 | completed | Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy |
| NCT04850378 CAPTAIN | Prot-0824-2019 | Ph 1, Ph 2 | completed | Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome |
| NCT03192215 ARCADIA results posted | AAAR4607 1U01NS095869-01A1 | Ph 3 | terminated | AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke |
| NCT04645550 | YZUC-005 | Ph 4 | completed | Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT） |
| NCT05643573 OCEANIC-AF results posted | 19767 2023-503794-38-00, 2022-000758-28 | Ph 3 | terminated | A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke |
| NCT04865978 DOAC LVAD results posted | U21-06-4470 | Ph 2 | completed | Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices |
| NCT02464969 results posted | B0661037 2014-002606-20, CV185-325 | Ph 4 | completed | Apixaban for the Acute Treatment of Venous Thromboembolism in Children |
| NCT06486792 SPICAF | APHP230839 | Ph 4 | recruiting | Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation |
| NCT01938248 ARTESiA | ARTESiA 2014-001397-33 | Ph 4 | completed | Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation |
| NCT02829957 (RAMBLE) results posted | RAMBLE | Ph 2, Ph 3 | completed | RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding |
| NCT02295475 ASTRO-APS | CV185-357 1040354 | Ph 4 | completed | Apixaban for Secondary Prevention of Thromboembolism Among Patients With AntiphosPholipid Syndrome |
| NCT02945280 ARM-DVT | CV185-512 | Ph 4 | terminated | Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis |
| NCT03987711 SAFE-D | SAFE-D-01 | Ph 2 | completed | Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis |
| NCT05152420 | VMX-C001-01 | Ph 1 | completed | Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects |
| NCT04512079 FREEDOM COVID | GCO 20-2115 | Ph 4 | completed | FREEDOM COVID-19 Anticoagulation Strategy |
| NCT04002011 DOAC/VKA | 21755 | Ph 2 | withdrawn | DOAC Versus VKA After Cardiac Surgery |
| NCT03678506 APIDULCIS | FAA I1. 7-2017 (APIDULCIS) 2017 002340 32 | Ph 4 | terminated | Apixaban for Extended Anticoagulation (APIDULCIS) |
| NCT03310021 results posted | 16-508 | Ph 2 | completed | A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects |
| NCT05035277 ACASA-TAVI | 247400 2021-001554-61 | Ph 3 | completed | AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation |
| NCT04218266 PACIFIC-AF results posted | 19765 2019-002365-35 | Ph 2 | completed | Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications. |
| NCT04041843 VTE | NYMC 191 | Ph 2 | completed | Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism |
Showing 50 of 118 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
ELIQUIS SPRINKLE FDA Label Details
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
View full patent landscape →
4 OB patents · 2 families ·
40 international docs across 21 countries
ELIQUIS SPRINKLE Patents & Exclusivity
Latest Patent: May 2041
Exclusivity: Oct 2028
Patents (4 active)
US11896586*PED
Expires May 22, 2041
US11896586
Expires Nov 22, 2040
US6967208*PED
Expires May 21, 2027
US6967208
Expires Nov 21, 2026
Exclusivity
NP
Until Apr 2028
PED
Until Oct 2028
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for ELIQUIS SPRINKLE
Revenue Insights
- • Q3-2026: $4.7B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 4 active patents
Trial Analysis
- • 115 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
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