Fentanyl clinical trials
Fentanyl is named as an intervention in 32 current clinical trials in our Egypt, Turkey, China, Singapore, France, Canada, USA and Denmark registers. 18 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Cairo University (4). The most-studied condition is Anesthesia. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Fentanyl is approved
All regulators →Of the three regulators tracked here, the first to approve Fentanyl was the US, on 19 Feb 1968. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Fentanyl
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Fentanyl works
All drug targets →- Mu opioid receptor agonist AgonistTarget: OPRM1 opioid receptor mu 1✓ In ChEMBL and the Guide to Pharmacology
- AgitationPhase 3
- COVID-19Phase 3
- CoughPhase 3
- DyspneaPhase 3
- Low back painPhase 3
- AbscessPhase 3
- Acute respiratory failurePhase 3
- AnxietyPhase 3
- AppendicitisPhase 3
- Cancer painPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL596, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 1626, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Fentanyl
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 49 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Fentanyl
- ChEMBL
- CHEMBL596
- DrugBank
- DB00813
- PubChem CID
- 3345
- CAS number
- 437-38-7
- FDA UNII
- UF599785JZ
- Wikidata
- Q407541
- Wikipedia
- Fentanyl
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Fentanyl
32 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Fentanyl in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Fentanyl. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Efficacy of sufentanil in urgent laparoscopic cholecystectomy: An alternative to the usual opioids for postoperative pain?
2026-525783-18-00 · CTIS ↗ · Digestive System Diseases
|
Phase 3 | Authorised | Fundacion Biomedica Galicia Sur | Spain |
|
GASPS Study: General Anaesthesia vs Spinal anaesthesia: Patient outcomes and Success in Outpatient primary total knee and hip Arthroplasty
2024-520127-89-00 · CTIS ↗ · Surgical Procedures, Operative
|
Phase 4 | Authorised | Region Oerebro Laen | Sweden |
|
Multicentre, open-label, randomized controlled non-inferiority trial comparing single dose intrathecal morphine and continuous thoracic epidural analgesia for multimodal analgesia in open colorectal surgery: the ColoREDIT protocol
2024-520262-58-01 · CTIS ↗ · Anesthesia and Analgesia
|
Phase 4 | Authorised | Region Vaestmanland | Sweden |
|
F-puff_SE_2024
2024-519131-42-02 · CTIS ↗ · Not possible to specify
|
Phase 4 | Authorised | Semmelweis University | Hungary |
Fentanyl across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
49 single-substance products containing Fentanyl on the HPRA medicines list.
- Abstral 100 microgram sublingual tabletsGrunenthal Pharma Limited. · PA2242/019/001 · Marketed
- Abstral 200 microgram sublingual tabletsGrunenthal Pharma Limited. · PA2242/019/002 · Marketed
- Abstral 300 microgram sublingual tabletsGrunenthal Pharma Limited. · PA2242/019/003 · Marketed
- Abstral 400 microgram sublingual tabletsGrunenthal Pharma Limited. · PA2242/019/004 · Marketed
- Abstral 600 microgram sublingual tabletsGrunenthal Pharma Limited. · PA2242/019/005 · Marketed
Supply shortages
- Fentanyl Citrate InjectionUS (FDA) · Current · updated 3 Nov 2026
Recent approvals
- Fentanyl Citrate Preservative FreeFDA · 3 May 2019 · Generic (ANDA) · Fresenius Kabi Usa
Conditions studied with Fentanyl
64 conditionsAll 64 conditions
| Condition (as registered) | Trials |
|---|---|
| Anesthesia | 3 |
| Cataract | 2 |
| Breakthrough Pain | 2 |
| Fentanyl | 2 |
| Fentanyl Overdose | 1 |
| Fentanyl Poisoning | 1 |
| Pediatric | 1 |
| Anesthesia Induction | 1 |
| Ciprofol | 1 |
| Laryngeal Mask Airway | 1 |
| Circumcision | 1 |
| Hydrocelectomy | 1 |
| Hernia | 1 |
| Renal Cyst | 1 |
| Paroxysmal Atrial Fibrillation | 1 |
| Limb Injury | 1 |
| Sedation | 1 |
| Hemodynamic | 1 |
| Hemodynamic Changes | 1 |
| Respiratory Distress Syndrome in Premature Infant | 1 |
| Posterior Spinal Instrumentation Patients | 1 |
| Thyroidectomy | 1 |
| Oxidative Stress | 1 |
| Intraoperative Hypotension | 1 |
| Spinal Aneshtesia | 1 |
| TURP(Transurethral Resection of Prostate) | 1 |
| Pain | 1 |
| Extracorporeal Shockwave Lithotripsy | 1 |
| Depression, Postpartum | 1 |
| Analgesia, Obstetrical | 1 |
| Anesthesia, Obstetrical | 1 |
| Labor Pain | 1 |
| Awake | 1 |
| Thoracic Epidural Anesthesia | 1 |
| General Anesthesia | 1 |
| Thoracotomy | 1 |
| Opioid Free Anesthesia | 1 |
| Ketorolac | 1 |
| Adjuvant | 1 |
| Peribulbar Block | 1 |
| Intrathecal | 1 |
| Dexmedetomidine | 1 |
| Bupivacaine | 1 |
| Procedural Pain | 1 |
| Spinal Anesthesia Duration | 1 |
| Diabete Mellitus | 1 |
| VATS | 1 |
| TIVA | 1 |
| Vaginal Delivery | 1 |
| Normal Labor | 1 |
| Epilepsy | 1 |
| Brain Tumor | 1 |
| Emergency Abdominal Surgery | 1 |
| Opioid Sparing Anaesthesia | 1 |
| Analgesia Assessment | 1 |
| Above Knee Amputation | 1 |
| Fentanyl vs Dexmedetomidine | 1 |
| Cardiac Disease Minimally Invasive Cardiac Surgery Postoperative Pain | 1 |
| Morbid Obesity | 1 |
| Cervical | 1 |
| Erector Spinae Plane Block | 1 |
| Proximal Humeral Fracture Surgery | 1 |
| Type 2 Diabetes Mellitus (T2DM) | 1 |
| Thoracic Surgery | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Cairo University | 4 |
| KK Women's and Children's Hospital | 3 |
| Ain Shams University | 3 |
| Nashwa Ahmed | 2 |
| Clear Scientific, Inc | 1 |
| Huazhong University of Science and Technology | 1 |
| Xiaguang Duan | 1 |
| China National Center for Cardiovascular Diseases | 1 |
| Assistance Publique - Hôpitaux de Paris | 1 |
| Saint-Joseph University | 1 |
| Copenhagen University Hospital, Rigshospitalet | 1 |
| Istanbul Medipol University Hospital | 1 |
| Istanbul University - Cerrahpasa | 1 |
| Malatya Egitim Ve Arastirma Hastanesi | 1 |
| Istanbul University | 1 |
+ 9 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Fentanyl trials
How many clinical trials are testing Fentanyl?
32 current trials in our Egypt, Turkey, China, Singapore, France, Canada, USA and Denmark registers name Fentanyl as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Fentanyl trials recruiting patients?
Yes. 18 of the 32 trials are recruiting: 10 with sites in Egypt, 1 with sites in Turkey, 2 with sites in China, 2 with sites in France, 1 with sites in Canada, 1 with sites in USA and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Fentanyl clinical trials?
Cairo University (4), KK Women's and Children's Hospital (3), Ain Shams University (3) and Nashwa Ahmed (2), among 24 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Fentanyl licensed in Ireland?
Yes. The HPRA medicines list includes 49 single-substance products containing Fentanyl, for example Abstral 100 microgram sublingual tablets (Grunenthal Pharma Limited.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Fentanyl shortage?
The registers we track list 1 entry for Fentanyl: US FDA: current. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Fentanyl works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Fentanyl works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Fentanyl (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.