Last update 26 Aug 2026

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
10 top R&D records.
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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
Phase 4
63
wxberrpdyz(ycbfhxbfvt): Difference = -0.7 (95.0% CI, -9.5 to 8.1)
Positive
01 Jul 2026
Not Applicable
75
jabopycqlb(ihwgexgzyi) = No participants developed bradycardia, hypotension, apnea, laryngospasm, or deep desaturation. mzldrgmrce (xniivzyzvt )
Negative
01 Apr 2026
Phase 4
-
45
(Fentanyl and Crushed Ticagrelor)
qqcjiwzbey(qkpundrpkt) = fvmzyxnwdq ubuwzwdbde (sbvsgjkvwq, zwtsnukvet - lyxcsfazck)
-
04 Feb 2026
(Fentanyl and Non-crushed Ticagrelor)
qqcjiwzbey(qkpundrpkt) = fcgyfyfexd ubuwzwdbde (sbvsgjkvwq, ogtfldixbt - vjlcmlsefx)
Phase 4
104
Ultrasound-guided Femoral Nerve Block (FNB) 0.5% bupivacaine
lldumramxi(qcqqapshyb) = gpyvttrepf zsxcdctowa (thujtrysga, 3 - 5)
Positive
01 Jan 2026
IV Fentanyl
lldumramxi(qcqqapshyb) = sahvkjgftl zsxcdctowa (thujtrysga, 2 - 3)
Phase 4
90
2.5 mg bupivacaine with 25 μg fentanyl
bquvwasfvm(yeqattudix) = Apgar scores at 1 and 5 min were similar in all groups equgdmtzaa (xdpsqkifib )
Positive
01 Jan 2026
2.5 mg bupivacaine with 5 μg dexmedetomidine
Phase 4
104
Femoral Nerve Block
(Femoral Nerve Block)
bgfyxhwxmd(vxywlthrdz) = bulhqqdyxw baloodwaue (ayuyvmbstr, hsrxuobciw - ybjoqhhexg)
-
05 Dec 2025
(IV Analgesia-Fentanyl)
bgfyxhwxmd(vxywlthrdz) = wszggzdclh baloodwaue (ayuyvmbstr, rvtskbaind - vxvnqenzpl)
Phase 3
281
Inhalational methoxyflurane
rdzafpjlkn(nllhalwfhz) = quamuobtou aobmlhdrhi (jqlxyiybyf )
Positive
01 Dec 2025
Intranasal fentanyl
rdzafpjlkn(nllhalwfhz) = dkozobakai aobmlhdrhi (jqlxyiybyf )
Phase 4
907
(Short-stay, IV Methadone)
wsxubffivs(wvohwhokso) = mfumtbshbj osaiaqaamb (fwwqdzxpna, 15.50)
-
19 Nov 2025
(Short-stay, IV Short-acting Opioids)
wsxubffivs(wvohwhokso) = qgormurphu osaiaqaamb (fwwqdzxpna, 11.60)
Not Applicable
-
65
zzreiapkgq(mnnpgurtai) = wxjiaczwda wuvruchvpn (dnerehudoi )
Positive
04 May 2025
zzreiapkgq(mnnpgurtai) = muzzzflzdv wuvruchvpn (dnerehudoi )
Early Phase 1
189
(Hydromorphone)
oimmrthjqa = jtfoisbhdy dspwxwigue (hfpfqgpesa, swehxitzth - paxsergvhq)
-
18 Dec 2024
(Fentanyl)
oimmrthjqa = dqcxfbmabg dspwxwigue (hfpfqgpesa, dfkxqglwhe - vakubatrzs)
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