Duragesic-100

(Fentanyl Citrate)

Phase 3Small molecule

Duragesic-100 is a small molecule that works as a Mu Opioid Receptor Agonist.[2] It is being investigated across 9 indications, with its most advanced program in Phase 3.[1]

Duragesic-100 is one of 204 small molecule programs targeting Chronic pain. It is currently in Phase 3.

Indications

Total Trials

Active Trials

203

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Chronic PainUnknown

Separation Anxiety DisorderActive, not recruiting

Migraine DisorderUnknown

Breast CancerActive, not recruiting

Neonatal PainNot yet recruiting

Intravenous AnesthesiaRecruiting

Fasting ConditionsCompleted

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Chronic PainPreclinical

Unknown

Separation Anxiety DisorderPreclinical

Active, not recruiting

Migraine DisorderPreclinical

Unknown

Breast CancerPreclinical

Active, not recruiting

Neonatal PainPreclinical

Not yet recruiting

Intravenous AnesthesiaPhase 2

Recruiting

Fasting ConditionsPreclinical

Completed

Hematopoietic and Lymphoid Cell NeoplasmPhase 3

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Duragesic-100

CCephalon

Phase 3

2 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Spravato

WWim Janssens

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Hematopoietic and Lymphoid Cell Neoplasm

NCT04188418

Q2 2028

PreclinicalNot yet recruiting

Neonatal Pain

NCT07112430

Q3 2029

Phase 3Recruiting

Analgesia

NCT05437575

Clinical

Trials by Indication[1]

Fentanyl4 trials

Studying Fentanyl in Patients With Cancer

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins··NCT00899951·2 enrolled

Effect of Fentanyl on Main Opioid Receptor (OPRM1) on Human Granulosa Cells.

Unknown status·GGeorge Papanicolaou Hospital··NCT03248076·30 enrolled

Effect of Sublingual Fentanyl on Breathlessness in COPD

Terminated·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 2/3·NCT04004117·40 enrolled

Show 1 more trial

Fentanyl Patch Pharmacokinetics in Healthy Adults

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT02531971·24 enrolled

Intravenous3 trials

Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

Completed·IINSYS Therapeutics Inc·Phase 1·NCT02576353·50 enrolled

Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

Completed·IINSYS Therapeutics Inc·Phase 1·NCT01780233·40 enrolled

Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children

Completed·UUniversity College Dublin·Phase 4·NCT03682211·31 enrolled

Breast Cancer2 trials

Effect of TIVA Propofol vs Sevoflurane Anaesthetic on Serum Biomarkers and on PBMCs in Breast Cancer Surgery

Withdrawn·TTata Memorial Centre·N/A·NCT03005860

Morphine for the Treatment of Pain in Patients With Breast Cancer

Completed·RRoswell Park Cancer Institute··NCT00003000·18 enrolled

Epidural Analgesia2 trials

Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Not yet recruiting·WWomen's Hospital HUS··NCT06094946·100 enrolled

Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

Completed·WWomen's Hospital HUS·Phase 4·NCT04645823·60 enrolled

Dyspnea2 trials

Inhaled Fentanyl Citrate & Dyspnea

Completed·MMcGill University·Phase 1·NCT01853449·14 enrolled

Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators

Completed·—·Phase 4·NCT03405090·20 enrolled

29 more indications

Perioperative Pain Management1 trial

Perioperative Pain Management for Lumbar Spine Surgery

Completed·—·N/A·NCT06662318·75 enrolled

General Anesthesia1 trial

Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia

Unknown status·TTang-Du Hospital·Phase 4·NCT02141737·272 enrolled

Esketamine1 trial

Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Unknown status·—·Phase 4·NCT03421275·105 enrolled

Patient-Controlled Analgesia1 trial

Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer

Completed·UUniversity of California, San Francisco··NCT00295945·240 enrolled

Premedication1 trial

Effects on Recovery of Children of Intravenous Formulation of Fentanyl Citrate and Midazolam Orally for Premedication

Active, not recruiting·—·N/A·NCT05500599·60 enrolled

Effectiveness1 trial

Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients

Withdrawn·UUNICANCER·Phase 2·NCT03809455

Interstitial Lung Disease1 trial

Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea

Completed·—·Phase 3·NCT03018756·21 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery

Unknown status·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 4·NCT03296488·110 enrolled

Obstructive Sleep Apnea1 trial

Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

Completed·—·Phase 1·NCT05051189·90 enrolled

Analgesic Efficacy1 trial

Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia

Completed·NNanjing Medical University·Phase 4·NCT00738192·150 enrolled

Analgesia1 trial

Prehospital Analgesia INtervention Trial (PAIN)

Recruiting·JJason Sperry·Phase 3·NCT05437575·994 enrolled

Intravenous Anesthesia1 trial

Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study

Recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT06017141·80 enrolled

Bupivacaine1 trial

Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery

Completed·RRoswell Park Cancer Institute·N/A·NCT00538499·30 enrolled

Vaso-occlusive Crisis1 trial

Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Completed·MMontefiore Medical Center·Phase 4·NCT01482091·124 enrolled

General Anaesthesia1 trial

Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Completed·YYonsei University·Phase 4·NCT01308320·42 enrolled

Ropivacaine1 trial

Comparison of Ropivacaine With or Without Fentanyl in Spinal Anaesthesia for Lower Limb Surgeries

Unknown status·TTribhuvan University Teaching Hospital, Institute Of Medicine.·Phase 4·NCT04199013·74 enrolled

Cancer Pain1 trial

Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

Completed·AArchimedes Development Ltd·Phase 3·NCT00589823·135 enrolled

Catheter1 trial

Talc Outpatient Pleurodesis With Indwelling Catheter

Unknown status·TThe Cooper Health System·N/A·NCT03973957·124 enrolled

Malignant Tumors1 trial

A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors

Recruiting·LLee's Pharmaceutical Limited·Phase 1·NCT06953453·100 enrolled

Anesthesia1 trial

Propofol-butorphanol Anesthesia During Uterine Curettage

Completed·NNanjing Medical University·Phase 4·NCT00795314·150 enrolled

Breakthrough Pain1 trial

An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.

Withdrawn·UUniversity of Louisville·Phase 4·NCT01839552

Fasting Conditions1 trial

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Completed·IINSYS Therapeutics Inc·N/A·NCT02138396·12 enrolled

Cardiovascular1 trial

Attenuation of Airway and Cardiovascular Responses to Extubation in Chronic Smokers

Unknown status·NNational Cancer Institute, Egypt·Phase 1·NCT04659642·66 enrolled

Local Anesthetic1 trial

Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

Completed·WWake Forest University Health Sciences·Phase 2·NCT01516684·33 enrolled

Epidural Block1 trial

Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

Completed·SSir Ganga Ram Hospital·N/A·NCT03812731·30 enrolled

Thoracic Paravertebral Block1 trial

Thoracic Paravertebral Block Versus IV Fentanyl Infusion

Unknown status·—·Phase 1/2·NCT03903367·44 enrolled

Acute Pain1 trial

Fentanyl OR Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Terminated·AAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Phase 3·NCT06051227·235 enrolled

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Efficacy and Safety of Rapid-Onset Opioids for Exertional Dyspnea in Cancer Patients

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 3·NCT04188418·150 enrolled

Neonatal Pain1 trial

Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial

Not yet recruiting·IIWK Health Centre·Preclinical·NCT07112430·58 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

SUBLIMAZE PRESERVATIVE FREE

NDA NDA016619

Jan 12, 1985

FENTANYL CITRATE

NDA NDA019115

Jan 30, 1985

FENTANYL CITRATE

NDA NDA019101

Nov 5, 1985

FENTANYL CITRATE

NDA NDA019101

Nov 5, 1985

FENTANYL CITRATE

NDA NDA019101

Nov 19, 1986

FENTANYL CITRATE

NDA NDA019101

May 17, 1989

FENTANYL CITRATE

NDA NDA019115

Nov 16, 1989

FENTANYL CITRATE

NDA NDA019101

Jan 11, 1990

FENTANYL CITRATE

NDA NDA019101

Jul 9, 1990

FENTANYL CITRATE

NDA NDA019115

Aug 7, 1990

DURAGESIC-100

NDA NDA019813

May 1, 1991

FENTANYL CITRATE

NDA NDA019101

Jul 18, 1991

FENTANYL CITRATE

NDA NDA019115

Jul 18, 1991

FENTANYL CITRATE

NDA NDA019115

Aug 7, 1991

FENTANYL CITRATE

NDA NDA019101

Aug 7, 1991

FENTANYL CITRATE

NDA NDA019101

Mar 10, 1992

FENTANYL CITRATE

NDA NDA019115

Apr 8, 1992

FENTANYL CITRATE

NDA NDA019115

Jun 25, 1992

FENTANYL CITRATE

NDA NDA019101

Jul 30, 1993

FENTANYL CITRATE

NDA NDA019115

Aug 30, 1993

FENTANYL CITRATE

NDA NDA019115

Mar 25, 1994

FENTANYL CITRATE

NDA NDA019101

Oct 30, 1995

FENTANYL

NDA NDA020195

Aug 15, 1996

FENTANYL CITRATE

NDA NDA019101

Oct 3, 1996

FENTANYL CITRATE

NDA NDA019115

Nov 2, 1998

FENTANYL CITRATE

NDA NDA019101

Nov 4, 1998

ACTIQ

NDA NDA020747

May 20, 1999

FENTANYL CITRATE

NDA NDA019101

Aug 4, 1999

FENTANYL CITRATE

NDA NDA019115

Jun 29, 2001

FENTANYL CITRATE

NDA NDA019101

Aug 28, 2001

FENTANYL CITRATE

NDA NDA019101

Oct 7, 2002

FENTANYL CITRATE

NDA NDA019115

Oct 25, 2002

FENTANYL CITRATE

NDA NDA019115

Jul 19, 2005

FENTANYL CITRATE

NDA NDA019115

May 22, 2006

IONSYS

NDA NDA021338

Sep 25, 2006

FENTORA

NDA NDA021947

Jul 16, 2009

ONSOLIS

NDA NDA022266

Feb 25, 2010

FENTANYL CITRATE

NDA NDA019101

Jan 7, 2011

ABSTRAL

NDA NDA022510

Jun 30, 2011

LAZANDA

NDA NDA022569

Jan 4, 2012

SUBSYS

NDA NDA202788

Feb 13, 2012

FENTANYL CITRATE

NDA NDA019101

Feb 6, 2013

FENTANYL CITRATE

NDA NDA019101

Mar 20, 2014

FENTANYL CITRATE

NDA NDA019101

May 21, 2014

FENTANYL CITRATE

NDA NDA019101

Jan 20, 2015

FENTANYL CITRATE

NDA NDA019101

Nov 9, 2015

FENTANYL CITRATE

NDA NDA019101

Feb 12, 2016

FENTANYL CITRATE

NDA NDA019101

May 26, 2016

FENTANYL CITRATE

NDA NDA019101

Dec 16, 2016

FENTANYL CITRATE

NDA NDA019101

Dec 16, 2016

FENTANYL CITRATE

NDA NDA019115

Dec 16, 2016

FENTANYL CITRATE

NDA NDA019115

Dec 16, 2016

FENTANYL CITRATE

NDA NDA019115

Jan 24, 2019

FENTANYL CITRATE

NDA NDA019101

May 3, 2019

FENTANYL CITRATE PRESERVATIVE FREE

NDA ANDA210762

Oct 7, 2019

FENTANYL CITRATE

NDA NDA019115

Oct 8, 2019

FENTANYL CITRATE

NDA NDA019101

Jun 17, 2021

FENTANYL CITRATE

NDA ANDA212086

Jan 20, 2023

FENTANYL CITRATE

NDA NDA019101

Feb 8, 2023

FENTANYL CITRATE

NDA NDA215870

Mar 3, 2023

FENTANYL CITRATE

NDA NDA019101

Dec 15, 2023

FENTANYL CITRATE

NDA NDA019101

Dec 15, 2023

FENTANYL CITRATE

NDA NDA019115

Dec 15, 2023

FENTANYL CITRATE

NDA NDA019101

Apr 24, 2025

FENTANYL CITRATE PRESERVATIVE FREE

NDA ANDA210762

Apr 24, 2025

FENTANYL CITRATE PRESERVATIVE FREE

NDA ANDA210762

Apr 24, 2025

FENTANYL CITRATE PRESERVATIVE FREE

NDA ANDA210762

Sep 25, 2025

FENTANYL CITRATE

NDA NDA019101

Dec 22, 2025

FENTANYL CITRATE

NDA NDA019115

Dec 22, 2025

FENTANYL CITRATE

NDA NDA019101

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Fentanyl Citrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fentanyl Citrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fentanyl Citrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA019115). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cephalon company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mu Opioid Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCephalon

Duragesic-100

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q2 2028

Q3 2029

Trials by Indication[1]

Fentanyl4 trials

Intravenous3 trials

Breast Cancer2 trials

Epidural Analgesia2 trials

Dyspnea2 trials

Perioperative Pain Management1 trial

General Anesthesia1 trial

Esketamine1 trial

Patient-Controlled Analgesia1 trial

Premedication1 trial

Effectiveness1 trial

Interstitial Lung Disease1 trial

Efficacy and Safety1 trial

Obstructive Sleep Apnea1 trial

Analgesic Efficacy1 trial

Analgesia1 trial

Intravenous Anesthesia1 trial

Bupivacaine1 trial

Vaso-occlusive Crisis1 trial

General Anaesthesia1 trial

Ropivacaine1 trial

Cancer Pain1 trial

Catheter1 trial

Malignant Tumors1 trial

Anesthesia1 trial

Breakthrough Pain1 trial

Fasting Conditions1 trial

Cardiovascular1 trial

Local Anesthetic1 trial

Epidural Block1 trial

Thoracic Paravertebral Block1 trial

Acute Pain1 trial

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Neonatal Pain1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News