ELIQUIS SPRINKLE (apixaban)
Eliquis Sprinkle helps patients with nonvalvular atrial fibrillation by lowering their risk of stroke and systemic blood clots. It is also used for patients recovering from hip or knee replacement surgery to prevent deep vein thrombosis and subsequent pulmonary embolisms. Furthermore, the medication treats active deep vein thrombosis and pulmonary embolisms while helping to prevent these conditions from recurring after initial therapy.
How ELIQUIS SPRINKLE Works
This medication works by selectively inhibiting Factor Xa, an enzyme essential for blood clot formation. It targets both free and clot-bound Factor Xa to decrease the generation of thrombin and the development of thrombi. While it does not directly affect platelets, it indirectly inhibits platelet aggregation by reducing thrombin levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-04-17
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION
ELIQUIS SPRINKLE Approval History
What ELIQUIS SPRINKLE Treats
5 indicationsELIQUIS SPRINKLE is approved for 5 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Stroke
- Systemic Embolism
- Atrial Fibrillation
- Deep Vein Thrombosis
- Pulmonary Embolism
ELIQUIS SPRINKLE Boxed Warning
BOXED WARNING WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. If anticoagulation with apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another antico...
BOXED WARNING WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. If anticoagulation with apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.4), Warnings and Precautions (5.1), and Clinical Studies ( 14.1)] . (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of apixaban and neuraxial procedures is not known [see Warnings and Precautions ( 5.3 )] Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions ( 5.3 )]. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions ( 5.3 )]. WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) PREMATURE DISC
ELIQUIS SPRINKLE Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
ELIQUIS SPRINKLE 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 ELIQUIS SPRINKLE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ELIQUIS SPRINKLE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ELIQUIS SPRINKLE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
110 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 | 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 | recruiting | 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 | not yet 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 | not yet recruiting | Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers |
| NCT06650501 DABI-SNAP | 2025-10900 500464 | Ph 4 | recruiting | Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia |
| NCT07471139 | AAAV9532 | Ph 3 | not yet 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 | not yet recruiting | BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis |
| NCT03266783 COBRRA | COBRRA | Ph 4 | completed | Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism |
| NCT02559856 COBRRA Pilot | 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 | not yet 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 |
| NCT06603870 STREAM-Line | STREAM-Line | Ph 4 | recruiting | Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis |
| 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 | not yet 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 | recruiting | 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. |
Showing 50 of 110 trials
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.
ELIQUIS SPRINKLE FDA Label Details
Indications & Usage
FDA Label (PDF)ELIQUIS SPRINKLE is indicated for the treatment of Stroke; Systemic Embolism; Atrial Fibrillation; Deep Vein Thrombosis; Pulmonary Embolism.
BOXED WARNING WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including apixaban, increases t...
ELIQUIS SPRINKLE Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ELIQUIS SPRINKLE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 4 active patents
Trial Analysis
- • 115 total trials
- • Stage: Stable
Competitive Landscape
- • 20 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