Fentanyl Citrate

Phase 3Small molecule

Fentanyl Citrate is a small molecule that works as a Mu Opioid Receptor Agonist.[2] It is being investigated across 17 indications, with its most advanced program in Phase 3.[1]

Fentanyl Citrate is one of 375 small molecule programs targeting Neuropathic Pain. It is currently in Phase 3.

Indications

Total Trials

Active Trials

374

Competitors

Pipeline

Status by Indication[3][1]

Indication

Neuropathic PainActive, not recruiting

Low Back PainActive, not recruiting

Migraine DisorderUnknown

Colon AdenocarcinomaActive, not recruiting

Retinopathy of PrematurityActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

Cancer PainActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Chronic PainUnknown

BurnActive, not recruiting

Neuropathic PainPhase 3

Active, not recruiting

Low Back PainPhase 3

Active, not recruiting

Migraine DisorderPreclinical

Unknown

Colon AdenocarcinomaPhase 2

Active, not recruiting

Retinopathy of PrematurityPhase 1/Phase 2

Active, not recruiting

Obstructive Sleep ApneaPhase 1

Active, not recruiting

Cancer PainPhase 3

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 2

Active, not recruiting

Chronic PainPreclinical

Unknown

BurnPhase 1

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Fentanyl Citrate

IINSYS Therapeutics Inc

Phase 3

2 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Malignant Tumors

NCT06953453

Q3 2027

Phase 3Active, not recruiting

Dyspnea

NCT04188418

Q2 2028

PreclinicalNot yet recruiting

Neonatal Pain

NCT07112430

Q3 2029

Phase 3Recruiting

Analgesia

NCT05437575

Clinical

Trials by Indication[1]

Fentanyl4 trials

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

Fentanyl Patch Pharmacokinetics in Healthy Adults

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

Show 1 more trial

Studying Fentanyl in Patients With Cancer

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

Dyspnea3 trials

Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

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

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

Completed·—·Phase 4·NCT03405090·20 enrolled

Inhaled Fentanyl Citrate & Dyspnea

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

Intravenous3 trials

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

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

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

Breast Cancer2 trials

Morphine for the Treatment of Pain in Patients With Breast Cancer

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

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

Withdrawn·TTata Memorial Centre·N/A·NCT03005860

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

27 more indications

Esketamine2 trials

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

Recruiting·—·Phase 3·NCT06051227·608 enrolled

Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

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

Thoracic Paravertebral Block1 trial

Thoracic Paravertebral Block Versus IV Fentanyl Infusion

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

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

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

Anesthesia1 trial

Propofol-butorphanol Anesthesia During Uterine Curettage

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

Perioperative Pain Management1 trial

Perioperative Pain Management for Lumbar Spine Surgery

Completed·—·N/A·NCT06662318·75 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

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

Epidural Block1 trial

Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

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

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

Cardiovascular1 trial

Attenuation of Airway and Cardiovascular Responses to Extubation in Chronic Smokers

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

Local Anesthetic1 trial

Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

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

Catheter1 trial

Talc Outpatient Pleurodesis With Indwelling Catheter

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

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

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

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]
SEC EDGAR — INSYS Therapeutics Inc 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: IINSYS Therapeutics Inc

Fentanyl Citrate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q3 2027

Q2 2028

Q3 2029

Trials by Indication[1]

Fentanyl4 trials

Dyspnea3 trials

Intravenous3 trials

Breast Cancer2 trials

Epidural Analgesia2 trials

Esketamine2 trials

Thoracic Paravertebral Block1 trial

Interstitial Lung Disease1 trial

Efficacy and Safety1 trial

Obstructive Sleep Apnea1 trial

Analgesic Efficacy1 trial

Analgesia1 trial

Ropivacaine1 trial

Anesthesia1 trial

Cancer Pain1 trial

Perioperative Pain Management1 trial

Bupivacaine1 trial

Vaso-occlusive Crisis1 trial

Breakthrough Pain1 trial

Fasting Conditions1 trial

Epidural Block1 trial

General Anesthesia1 trial

Malignant Tumors1 trial

Cardiovascular1 trial

General Anaesthesia1 trial

Local Anesthetic1 trial

Patient-Controlled Analgesia1 trial

Premedication1 trial

Catheter1 trial

Effectiveness1 trial

Intravenous Anesthesia1 trial

Neonatal Pain1 trial

References

Drug Info

Quick Facts

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