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Drug

Fentanyl

Approved · FDA / EMA
ClassMu opioid receptor agonistEmerging researchLate-stage developmentRising momentum
Also known as 1-Phenethyl-4-(N-phenylpropionamido)piperidine, 1-phenethyl-4-N-propionylanilinopiperidine, Abstral, Actiq+22 more

1-Phenethyl-4-(N-phenylpropionamido)piperidine, 1-phenethyl-4-N-propionylanilinopiperidine, Abstral, Actiq, Droperidol-Fentanyl, Duragesic, Fentanyl CII, Fentora, Innovar, Ionsys, Lazanda, N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide, N-(1-phenethyl-4-piperidinyl)-N-phenylpropionamide, N-(1-phenethyl-4-piperidyl)propionanilide, N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide, N-phenethyl-4-(N-propionylanilino)piperidine, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide, Onsolis, Phentanyl, Sublimaze, Subsys, Fentanil, Fentanila, Fentanilo, FentaNYL Citrate, Fentanylum.

3
Research papers
23
Active clinical trials
Mu-type opioid receptor
Primary target
93
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fentanyl
Aliases & brands
1-Phenethyl-4-(N-phenylpropionamido)piperidine1-phenethyl-4-N-propionylanilinopiperidineAbstralActiqDroperidol-FentanylDuragesicFentanyl CIIFentoraInnovarIonsysLazandaN-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamideN-(1-phenethyl-4-piperidinyl)-N-phenylpropionamideN-(1-phenethyl-4-piperidyl)propionanilideN-(1-phenethylpiperidin-4-yl)-N-phenylpropionamideN-phenethyl-4-(N-propionylanilino)piperidineN-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamideOnsolisPhentanylSublimazeSubsysFentanilFentanilaFentaniloFentaNYL CitrateFentanylum
RxNorm CUI
4337
ChEMBL ID
CHEMBL596
ATC codes
N02AB03N01AH01N01AH51
UNII
UF599785JZ
Primary mechanism
Mu opioid receptor agonist
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

AGONISTMu opioid receptor agonist

Regulatory timeline

93 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2008-04-042009-07-20)
Approval / market entry confirmed across FDA and EMA (2010-08-312012-07-09)
Earliest approval
2005-01-28
Latest approval
2026-06-18
Authorities
FDA · EMA
Total events
93
fdaU.S. Food and Drug Administration· 90 events
2026-06-18Supplemental approval
Supplemental approval: FENTANYL (ANDA076258)
Evidence ↗
2026-06-18Supplemental approval
Supplemental approval: FENTANYL (ANDA077449)
Evidence ↗
2026-06-18Supplemental approval
Supplemental approval: FENTANYL TRANSDERMAL (ANDA077154)
Evidence ↗
emaEuropean Medicines Agency· 3 events
2010-08-31ApprovalMulti-authority
Approval: PecFent (EMA)
Indication: PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is aShow full indication

PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.

Evidence ↗
2009-07-20ApprovalMulti-authority
Approval: Instanyl (EMA)
Indication: Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitoryShow full indication

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.  Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Evidence ↗
2008-04-04ApprovalMulti-authority
Approval: Effentora (EMA)
Indication: Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is aShow full indication

Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

189 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
189
registered trials across all phases
LATEST COMPLETION 2026
23
Active studies
16
Recruiting
160
Late-stage (III+)
100
Completed
66
Discontinued
PHASE DISTRIBUTIONn = 189
Early Phase 15Phase 18Phase 1 / 25Phase 211Phase 2 / 37Phase 324Phase 467Phase N / A62

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20072025
Major research themes7
Analgesia, Patient-Controlled1Emergency Service, Hospital1Endosonography1Fentanyl1Mental Disorders1Opioid-Related Disorders1Substance-Related Disorders1
Journals, researchers & institutions
Top journals
  • Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver1
  • Nature communications1
  • Scientific reports1
Leading researchers
  • Abrahao A1
  • Agostoni M1
  • Arcidiacono PG1
  • Aubert I1
  • Black SE1
  • Downs A1
  • Fanti L1
  • Gemma M1
Leading institutions
free-text, unnormalised
  • Department of Laboratory Medicine and Pathobiology1
  • Harquail Centre for Neuromodulation1
  • Heersink School of Medicine1
  • Institute of Biomaterials and Biomedical Engineering1
  • Sunnybrook Health Sciences Centre1
  • Sunnybrook Research Institute1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across the same disease area as Fentanyl in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.