ClinicalTrials.gg
Drug

Fentanyl clinical trials

Also written Sublimaze, Duragesic, CEP-25608 and Fentanest.

Includes 6 studies of Fentanyl hydrochloride and 3 studies of Fentanyl Citrate Pectin-Based Nasal Spray.

studies test it
425
open now
56
in phase 3
69
first study started
1996

How each study uses Fentanyl is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Get an email when these change. Save the Fentanyl studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.

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Approvals

The first approval found in each region, with its record

United States
19 Feb 1968 · SUBLIMAZE PRESERVATIVE FREE · NDA 016619 (FDA, Drugs@FDA)
European Union
24 Jan 2006 · Ionsys · EMEA/H/C/000612 (EMA; now withdrawn)

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

Fentanyl
237
Fentanyl Citrate
32
Fentanyl (IV)
9
Opioid
6
Durogesic
6

Brand

Sublimaze
13
Duragesic
9
Fentora
6
Abstral
4
Actiq
4
Pecfent
2
Lazanda
2
Effentora
1

Development codes

CEP-25608
3
EN3267
2
JNS020QD
2
KW-2246
1
AD 923
1

Other names

Fentanest
3
Matrifen
1

In one entry with another drug

Given together, or one or the other

Bupivacaine-fentanyl
7
Bupivacaine + Fentanyl
5
Bupivacaine, fentanyl
4
Fentanyl/Hydromorphone
3
Fentanyl and Midazolam
3
Fentanyl and Bupivacaine
2
midazolam with fentanyl
2
Dexmedetomidine and Fentanyl
2

Studies by the year they started

424 studies that test it; most in 2024 (33)

Studies that test Fentanyl, by start year
YearStudies
19962
19991
20001
20012
20023
20037
20048
20059
200613
200710
200822
200914
201012
201125
201215
201312
201421
201524
201617
201723
201816
201921
202022
202112
202217
202318
202433
202532
202612

By phase

A phase 1/2 study counts in both.

Early Phase 1
12
Phase 1
34
Phase 2
53
Phase 3
69
Phase 4
144
No phase
138

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Who runs them

Industry 64 · Other 361

Assiut University (20) · Ain Shams University (15) · Cairo University (9) · Tanta University (8) · M.D. Anderson Cancer Center (7) · Kyowa Kirin Co., Ltd. (6) · INSYS Therapeutics Inc (6) · Cephalon (6)

Often tested with

Tested in the same studies.

Dexmedetomidine (51) · Bupivacaine (37) · Midazolam (33) · Propofol (31) · Morphine (19) · Lidocaine (18) · Ketamine (18) · Ropivacaine (16)

Related medicines

As reviewed, each with the page that says it.

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Tested against it · 3 phase 3 studies under way

Fentanyl is the comparator. A study of two new drugs counts under both.

  • 2Ketamine · Children's Cancer Hospital Egypt 57357, Jason Sperry · next primary completion Mar 2027
  • 1Dexmedetomidine · Indonesia University
Reaching primary completion within a year · 19, 2 in phase 3

Studies that test Fentanyl, phase 3 first.

Studies

Open first, then newest update. How each study uses Fentanyl is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 425

See all 425 studies that test Fentanyl →

Given beside what is tested · 134 — Fentanyl is usual care or a partner of the new treatment

Showing 20 of 134.

As the comparator · 138 — what is tested is compared with Fentanyl

Showing 20 of 138.

What changed recently

From the registry's own updates since Oct 15, 2026.

Codes

What other systems call Fentanyl · ClinicalTrials.gg INT007483

  • MeSH (NLM) D005283FentanylConfirmed ClinicalTrials.gov, NLM, Wikidata
  • UNII (FDA) UF599785JZFENTANYLConfirmed FDA, NLM, Wikidata
  • RxNorm 4337Confirmed FDA, Wikidata
  • Wikidata Q407541fentanylConfirmed FDA, NLM, Wikidata
  • NCI Thesaurus C494FentanylOne source FDA
  • DrugBank DB00813One source Wikidata

Also registered as fentanyl citrate (UNII MUN5LYG46H · RxNorm 142436).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.