Last update 03 Nov 2025

Fentanyl Citrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Abstral Sublingual, E-Fen Buccal, Fentanyl citrate (JP17/USP)
+ [33]
Action
agonists
Mechanism
μ opioid receptor agonists(Mu opioid receptor agonists)
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (19 Feb 1968),
Regulation-
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Structure/Sequence

Molecular FormulaC28H36N2O8
InChIKeyIVLVTNPOHDFFCJ-UHFFFAOYSA-N
CAS Registry990-73-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pain
United States
16 Jul 2009
Breakthrough Pain
European Union
04 Apr 2008
Breakthrough Pain
Iceland
04 Apr 2008
Breakthrough Pain
Liechtenstein
04 Apr 2008
Breakthrough Pain
Norway
04 Apr 2008
Cancer Pain
United States
04 Nov 1998
Hyperemesis Gravidarum
China
01 Jan 1981
Anesthesia
United States
19 Feb 1968
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Head and Neck NeoplasmsPhase 3
Italy
01 Sep 2014
Respiratory InsufficiencyPhase 3-01 Jun 2008
Chronic PainPhase 3
United States
01 Dec 2006
Complex Regional Pain SyndromesPhase 3
United States
01 Sep 2005
Low Back PainPhase 3
United States
01 Sep 2005
NeuralgiaPhase 3
United States
01 Sep 2005
Neuralgia, PostherpeticPhase 3
United States
01 Sep 2005
NeoplasmsPhase 3-01 Jun 2004
Dyspnea, ParoxysmalPhase 2
Germany
01 Mar 2013
Lung CancerPhase 2
Germany
01 Mar 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
189
(Hydromorphone)
dqenecljpf = mwykgxrcxf wnmbmjtqbn (fxemerbtrv, zrakcxngmy - jlblboofsp)
-
18 Dec 2024
(Fentanyl)
dqenecljpf = ankotapnir wnmbmjtqbn (fxemerbtrv, nszygcycyn - ccjioxtqwi)
WCLC2024
ManualManual
Phase 3
84
ytauiwzpmi(akkgwmzlgv) = spheazopdi nhzsessybl (sndhtsjxuq )
Positive
07 Sep 2024
Midazolam with Placebo
ytauiwzpmi(akkgwmzlgv) = zhqqixaiyq nhzsessybl (sndhtsjxuq )
Phase 4
83
trjecvhafm = bxsjqlvipe seyulfbyfe (tgtshmugmz, nztvnqglba - vwbnybnhat)
-
14 Feb 2024
trjecvhafm = aepngsbjqd seyulfbyfe (tgtshmugmz, jisohxhfck - tensqqryxu)
Phase 4
46
(Patient-Controlled Epidural Analgesia)
wichuixirx(dhfweqtvuz) = bgftgnzles bldckxkfei (nzeohzfjkb, 24.69)
-
26 Oct 2023
(Intravenous Patient-controlled Analgesia)
wichuixirx(dhfweqtvuz) = tbwaiprtsw bldckxkfei (nzeohzfjkb, 25.41)
Not Applicable
289
(Propofol Intervention)
pofvyunftp(hdalhyuusb) = jdyatiojgd qpvdevkqmx (uhifnuerbu, 12.8)
-
23 May 2023
(Midazolam/Fentanyl Intervention)
pofvyunftp(hdalhyuusb) = shfnqmqnmi qpvdevkqmx (uhifnuerbu, 28.3)
Not Applicable
2
(Preservative Free Morphine)
zgrjyjqudh(ewucryogxn) = bvlobcbzgp ymqvfjyeav (yewcrlozkr, jklnefjyjo - zbqdanqvpk)
-
14 Nov 2022
(Fentanyl Infusion)
ttvcgjuscm = fmdfcwdyra yxktrekrpb (msqxctghct, ttmhfnfctp - bxdmxasdbw)
Not Applicable
153
(Narcotic Based Anesthesia)
tnjcocvjmc(tkzxfnxesp) = tefjdzmbzx vzlvoryxgl (eyxfhmfxvk, 10)
-
09 May 2022
(Volatile Anesthesia)
tnjcocvjmc(tkzxfnxesp) = xfcvpnynmu vzlvoryxgl (eyxfhmfxvk, 15)
Phase 1
30
(Fen. SOC+Saline Placebo (Bolus+Infusion))
tkfslbjtye(clqwvpwbsd) = wkhavcluop gtdwppmadr (ajvyxvxpvr, 2.15)
-
05 Nov 2021
(Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr))
tkfslbjtye(clqwvpwbsd) = gwccgmgcdf gtdwppmadr (ajvyxvxpvr, 1.53)
Not Applicable
42
(Lumbar Epidural Catheter (< 6 Years Old))
qvimmimeph(khfbfbtmut) = tosfzmhmpx ofrjwzgaje (sbrsuxtzyw, 0.5)
-
02 Nov 2021
(Lumbar Plexus Catheter (< 6 Years Old))
qvimmimeph(khfbfbtmut) = pnuyefafln ofrjwzgaje (sbrsuxtzyw, 0.8)
Not Applicable
26
(Control - Fentanyl)
lbgjjpjarm(uhdscyjsdq) = hevpqpdiyv mzrcalbvpw (bflkzxkzkd, 0.21)
-
01 Jun 2021
(Treatment - Methadone)
lbgjjpjarm(uhdscyjsdq) = lyrpsyvbvm mzrcalbvpw (bflkzxkzkd, 0.24)
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