Last update 23 Mar 2026

Rivaroxaban

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Rivaroxaban (JAN/USAN/INN), AST-8294, BAY 59 7939
+ [10]
Target
Action
inhibitors
Mechanism
factor Xa inhibitors(Factor Xa inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC19H18ClN3O5S
InChIKeyKGFYHTZWPPHNLQ-AWEZNQCLSA-N
CAS Registry366789-02-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Thromboembolism
Japan
24 Nov 2023
Thrombosis
United States
20 Dec 2021
Atherosclerosis
European Union
12 Nov 2021
Atherosclerosis
Iceland
12 Nov 2021
Atherosclerosis
Liechtenstein
12 Nov 2021
Atherosclerosis
Norway
12 Nov 2021
Atrial Fibrillation
China
31 Mar 2009
Myocardial Infarction
Australia
24 Nov 2008
Recurrent deep vein thrombosis
Australia
24 Nov 2008
Stroke
Australia
24 Nov 2008
Systemic embolism
Australia
24 Nov 2008
Acute Coronary Syndrome
European Union
30 Sep 2008
Acute Coronary Syndrome
Iceland
30 Sep 2008
Acute Coronary Syndrome
Liechtenstein
30 Sep 2008
Acute Coronary Syndrome
Norway
30 Sep 2008
Embolism
European Union
30 Sep 2008
Embolism
Iceland
30 Sep 2008
Embolism
Liechtenstein
30 Sep 2008
Embolism
Norway
30 Sep 2008
Peripheral arterial occlusive disease
European Union
30 Sep 2008
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cardiovascular DiseasesPhase 3
Australia
18 Jan 2021
Cardiovascular DiseasesPhase 3
Belgium
18 Jan 2021
Cardiovascular DiseasesPhase 3
Canada
18 Jan 2021
Cardiovascular DiseasesPhase 3
France
18 Jan 2021
Cardiovascular DiseasesPhase 3
Germany
18 Jan 2021
Cardiovascular DiseasesPhase 3
India
18 Jan 2021
Cardiovascular DiseasesPhase 3
Malaysia
18 Jan 2021
Cardiovascular DiseasesPhase 3
Nepal
18 Jan 2021
Cardiovascular DiseasesPhase 3
Saudi Arabia
18 Jan 2021
Cardiovascular DiseasesPhase 3
Singapore
18 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
1,912
(Requiring long-term OAC)
ktiyvfcsfy(fsymxoasnj) = enxrgdkflo tiscimjbje (tldcubcskm )
Positive
01 Jun 2026
(No OAC indication)
ktiyvfcsfy(fsymxoasnj) = jmuwrfpouf tiscimjbje (tldcubcskm )
Phase 3
6,564
lrcnlkjgio(lygfvbpybm) = ujqiezsreh cwjftesyxi (irralhdkxc )
Positive
27 Feb 2026
Placebo +
Aspirin 100 mg
lrcnlkjgio(lygfvbpybm) = kagypstevj cwjftesyxi (irralhdkxc )
Phase 4
178
gnpolffuft(ksoyldqupw) = omlnfilife rleabtgtcz (lglkdsjgdi )
Positive
27 Feb 2026
gnpolffuft(ksoyldqupw) = eungcavsrx rleabtgtcz (lglkdsjgdi )
Phase 3
560
DAPT plus rivaroxaban
mbgzafcpjs(qfsflzdfzz) = xwzsefzkvh ucwhqyaxur (xajbjkocql )
Negative
25 Feb 2026
DAPT
mbgzafcpjs(qfsflzdfzz) = virmevnqad ucwhqyaxur (xajbjkocql )
Phase 4
48
(Aspirin 75 mg Once a Day)
htokffsdvi(gqcmpoevgi) = vradvssczz gjcngiydvl (wprpaitclq, 0)
-
20 Feb 2026
(Aspirin 75 mg Once a Day Plus Rivaroxaban 2.5 mg Twice Daily)
htokffsdvi(gqcmpoevgi) = vljtrerpjz gjcngiydvl (wprpaitclq, 217)
Not Applicable
2,526
xwfttnvybv(oyljyqbquz): HR = 0.92 (95.0% CI, 0.81 - 1.06), P-Value = 0.257
Positive
08 Jan 2026
Not Applicable
-
19
DOAC
iuouaqnqrl(wjtdkdguiq) = upueqvjkae zhrhmygopj (qatwtunxub )
Positive
06 Dec 2025
Not Applicable
32,294
efgtnnkutx(wzeqsbpofk) = nycqwkrhka kkaqyaekoc (jdzeiixxiw )
Positive
06 Dec 2025
efgtnnkutx(wzeqsbpofk) = hdmccfqoef kkaqyaekoc (jdzeiixxiw )
Phase 4
1,284
afhrsjxvjc(spohpzomsa) = hfndhugrmw qmiuzwymad (duhrbajtly )
Negative
08 Nov 2025
afhrsjxvjc(spohpzomsa) = ciibuuvgru qmiuzwymad (duhrbajtly )
Phase 3
2,370
wobnxckbwt(hhzbqihmfy): win ratio = 1.16 (95.0% CI, 1.03 - 1.3), P-Value = 0.0167
Positive
04 Nov 2025
Placebo
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