TheraRadar
Data updated: May 26, 2026

ABSTRAL (fentanyl citrate)

Pain Approved 2011-01-07
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Discontinued
First Approved
2011-01-07
Routes
SUBLINGUAL
Dosage Forms
TABLET

Companies

SENTYNL THERAPS INC
Active Ingredient: FENTANYL CITRATE

ABSTRAL Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 2011 to 2019
Oct 2019 SUPPL
Label · Labeling
FDA Letter Label
Sep 2017 SUPPL
Update · REMS
FDA Letter
Dec 2016 SUPPL
Label · Labeling
FDA Letter Label

What ABSTRAL Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
📋

Clinical Trial Registry

14 trials
Trial Sponsor ID Phase Status Title
NCT05437575 PAIN STUDY22010164 HT9425-25-F-0041 Ph 3 recruiting Prehospital Analgesia INtervention Trial (PAIN)
NCT06051227 FORE-PAIN FP-2023 2022-500176-63-00, U1111-1287-7486 Ph 3 recruiting Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
NCT04645823 Versio4_22112020 2020-005506-26 Ph 4 completed Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
NCT03018756 DMED-1921-16 Ph 3 completed Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea
NCT03405090 DMED-1926-16 Ph 4 completed Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators
NCT06017141 STUDY00149314 NCI-2023-05587, IIT-2022-VIVA Ph 2 recruiting Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
NCT03809455 FARADI UC-0106/1607 SdS 02 FARADI Ph 2 withdrawn Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
NCT01516684 results posted IRB00017079 NCI-2012-00019, CCCWFU 01211 Ph 2 completed Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures
NCT03682211 SCC01 2011-005161-20, ISRCTN67469672 Ph 4 completed Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children
NCT01482091 results posted 11-09-343 Ph 4 completed Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
NCT02576353 INS002-15-049 Ph 1 completed Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
NCT01308320 4-2009-0111 Ph 4 completed Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
NCT00795314 PABADUC NMU-2008-FY10MZ31 NJFY0811-MZ02 Ph 4 completed Propofol-butorphanol Anesthesia During Uterine Curettage
NCT00738192 CARAN NMU-FY2008-311 NJFY0807311M Ph 4 completed Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ABSTRAL FDA Label Details

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Data Sources

FDA Approval: NDA022510 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.