Data updated: Jun 28, 2026
ADENOSINE · GLAND PHARMA LTD
Generic · see ADENOSCAN Adenosine Receptor Agonists
Cardiovascular
Approved 1989-10-30
Intravenous adenosine injection, USP is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection, USP administration.
18
Indications
--
Phase 3 Trials
36
Years on Market
Details
- Status
- Prescription
- First Approved
- 1989-10-30
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
GLAND PHARMA LTD PHARMOBEDIENT Fresenius Kabi RISING Hikma AVET LIFESCIENCES Pfizer GLAND Teva WOCKHARDT LTD BEDFORD EUGIA PHARMA Viatris AM REGENT MEITHEAL
Active Ingredient: ADENOSINE
Website: ↗
ADENOSINE Approval History
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
62 FDA actions from 2004 to 2024
Jul 2024 SUPPL
Label · Labeling
Oct 2023 SUPPL
Label · Labeling
Apr 2018 ORIGINAL
Update
Feb 2018 ORIGINAL
Update
Nov 2017 ORIGINAL
Update
Nov 2017 ORIGINAL
Update
Apr 2016 SUPPL
Label
Sep 2015 SUPPL
Label
Jun 2015 SUPPL
Label
May 2015 SUPPL
Label
May 2015 SUPPL
Label
Oct 2014 ORIGINAL
Update
Sep 2014 SUPPL
Mfg
Sep 2014 ORIGINAL
Update
Mar 2014 ORIGINAL
Update
Mar 2014 ORIGINAL
Update
Mar 2014 ORIGINAL
Update
Sep 2013 SUPPL
Label
Feb 2011 SUPPL
Label
Jan 2011 SUPPL
Mfg
Jul 2010 SUPPL
Label
Mar 2010 SUPPL
Label
Mar 2010 SUPPL
Label
Mar 2010 SUPPL
Label
Mar 2010 SUPPL
Label
Feb 2010 SUPPL
Label
Nov 2009 SUPPL
Label
Jul 2009 ORIGINAL
Update
May 2009 ORIGINAL
Update
Apr 2009 ORIGINAL
Update
Oct 2008 ORIGINAL
Update
Jul 2008 ORIGINAL
Update
Apr 2008 SUPPL
Label
Jan 2008 SUPPL
Label
Jun 2007 ORIGINAL
Update
Nov 2006 SUPPL
Label
Nov 2006 SUPPL
Label
Apr 2006 SUPPL
Label
Apr 2005 ORIGINAL
Update
What ADENOSINE Treats
18 FDA approvalsOriginally approved for its first indication in 2004 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Jun 2004)Letter
- • Approved indication (Apr 2005)
- • Approved indication (Jun 2007)
- • Approved indication (Jul 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Aug 2013)Label Letter
- • Approved indication (Mar 2014)
- • Approved indication (Mar 2014)
- • Approved indication (Mar 2014)
- • Approved indication (Sep 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Nov 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Feb 2018)
- • Approved indication (Apr 2018)
📋
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 |
🔬
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.
ADENOSINE FDA Label Details
Indications & Usage
FDA Label (PDF)Intravenous adenosine injection, USP is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection, USP administration. It is important to be sure the adenosine injection, USP solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine injection, USP does not convert atrial flutter, atrial fibrill...
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Full clinical data, patents, trials, and competitive landscape for adenosine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.