Data updated: Jul 17, 2026
ADENOCARD (adenosine) · ASTELLAS
Cardiovascular
Approved 1989-10-30
1
Indication
--
Phase 3 Trials
1
Priority Reviews
36
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1989-10-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ADENOCARD Approval History
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 1989 to 2013
Dec 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
Feb 2011 SUPPL
Label · Labeling
Sep 2001 SUPPL Priority
Mfg
Feb 2000 SUPPL Priority
Mfg
Nov 1999 SUPPL Priority
Mfg
Apr 1999 SUPPL
Label
Feb 1997 SUPPL Priority
Mfg
Jul 1996 SUPPL
Label
Feb 1996 SUPPL
Label
Dec 1995 SUPPL Priority
Mfg
Jun 1995 SUPPL Priority
Mfg
Jun 1995 SUPPL
Label
Apr 1994 SUPPL Priority
Mfg
Oct 1993 SUPPL Priority
Mfg
Jun 1992 SUPPL
Label
Nov 1990 SUPPL Priority
Mfg
Sep 1990 SUPPL
Label
May 1990 SUPPL
Label
Dec 1989 SUPPL Priority
Mfg
Oct 1989 ORIGINAL Priority
New Drug
What ADENOCARD Treats
1 FDA approvalsOriginally approved for its first indication in 1989 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 1989) Priority
ASTELLAS's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06993038 COMFORT-ED | 202412202 | Ph 4 | recruiting | Adenosine vs Diltiazem for Treatment of SVT in the ED |
| NCT03218137 | 1609017561 | Ph 4 | recruiting | Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions |
| NCT06578234 HYPER | 2023-505248-20-00 | Ph 4 | recruiting | Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses |
| NCT06717685 | PIC001/2024 | Ph 3 | recruiting | Efficacy of Adenosine as Compared to Verapamil in Paroxysmal Supraventricular Tachycardia (pSVT) Patients |
| NCT04666454 | BROKEN SWEDEHEART | Ph 4 | recruiting | BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. |
| NCT03557385 ACCELERATION results posted | Pro00093001 | Ph 4 | completed | Adenosine Contrast CorrELations in Evaluating RevAscularizaTION |
| NCT05014061 A-STAMI | EudraCT number: 2021-001466-37 | Ph 3 | withdrawn | Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction |
| NCT04588441 | IRB202002127 OCR39505 | Ph 2 | withdrawn | The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19 |
| NCT03236311 results posted | ACT14656 2016-000629-38, U1111-1182-1709 | Ph 2 | terminated | A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI |
| NCT04392362 AHAvsSIM results posted | UPretoria | Ph 3 | completed | A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT) |
| NCT04699110 | ERC-76/2020 | Ph 4 | completed | Adrenaline for the Treatment of No-Reflow in Normotensive Patients |
| NCT03249272 results posted | Pro00082447 | Ph 4 | terminated | Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve |
| NCT02867878 TITAN | 160596 | Ph 2 | terminated | Adenosin to Rapidly Reverse Left Ventricle Impairment in Takotsubo Syndrome |
| NCT01690884 | 120477 | Ph 1 | completed | Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake |
| NCT02462941 | AAAO8054 | Ph 1 | completed | Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart |
| NCT03032965 results posted | HUM00048922 | Ph 2 | completed | Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation |
| NCT03231371 CFR-OHT results posted | HUM23585 | Ph 3 | completed | Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients |
| NCT01161121 results posted | Rega-9I06 | Ph 1 | completed | Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia |
| NCT01234870 results posted | CR1_STU00006013 ASCA-9J02 | Ph 2, Ph 3 | completed | Comprehensive Evaluation of Ischemic Heart Disease Using MRI |
| NCT01809743 | NL42049.060.12 | Ph 3 | completed | Regadenoson and Adenosine |
| NCT00781404 PROMISE | HUValldHebronRI 2007-006671-36 | Ph 3 | completed | Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI |
| NCT00590070 REOPEN-AMI | REOPEN-AMI 2007-006794-93 2007-006794-93 | Ph 2, Ph 3 | completed | THE REOPEN-AMI STUDY - Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction |
| NCT01148147 PREVENT-ICARUS | CE 93/09 2009-013681-92 | Ph 3 | completed | Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty |
| NCT01123525 | AdCard 2010 2008-004274-40 | Ph 1, Ph 2 | completed | Adenosine Cardioplegia; Improved Cardioprotection? |
| NCT00881686 | xinzangwaike0002 | Ph 1, Ph 2 | completed | Myocardial Protection With Adenosine Preconditioning |
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Pro Active Pipeline
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.
ADENOCARD FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.