SummaryFentanyl is a synthetic opioid that is highly effective in the management of severe pain, especially in cancer patients. It exerts its analgesic effects by binding to opioid receptors in the central nervous system. Fentanyl is available in various formulations, including transdermal patches, lozenges, and injectable solutions. However, due to its potency, fentanyl carries a high risk of addiction, respiratory depression, and overdose. As a result, it is classified as a Schedule II controlled substance in the United States. Ongoing research is focused on developing safer and more effective delivery methods for fentanyl, such as abuse-deterrent formulations and novel routes of administration. |
Drug Type Small molecule drug |
Synonyms AeroLEF, AVERSA Fentanyl, Fentany Transdermal System + [39] |
Target |
Action agonists |
Mechanism Opioid receptors agonists(Opioid receptors agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (07 Aug 1990), |
Regulation- |
Molecular FormulaC22H28N2O |
InChIKeyPJMPHNIQZUBGLI-UHFFFAOYSA-N |
CAS Registry437-38-7 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Cancer Pain | Japan | 01 Feb 2011 | |
| Pain | Australia | 23 Nov 2005 | |
| Acute Pain | United States | 04 Feb 2005 | |
| Chronic Pain | United States | 04 Feb 2005 | |
| Hypoventilation | United States | 07 Aug 1990 | |
| Pain, Postoperative | United States | 07 Aug 1990 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Mucositis | Phase 3 | United States | 01 Oct 2009 | |
| Solid tumor | Phase 3 | United States | 01 Oct 2009 | |
| Stomatitis | Phase 3 | United States | 01 Oct 2009 | |
| Low Back Pain | Phase 3 | Japan | 01 Jan 2009 | |
| Osteoarthritis | Phase 3 | Japan | 01 Jan 2009 | |
| Complex Regional Pain Syndromes | Phase 3 | Japan | 01 Dec 2008 | |
| Neuralgia, Postherpetic | Phase 3 | Japan | 01 Dec 2008 | |
| Pain Disorder | Phase 3 | Japan | 01 Dec 2008 | |
| Neoplasms | Phase 3 | Canada | 01 Dec 2007 | |
| Neoplasms | Phase 3 | India | 01 Dec 2007 |
Phase 3 | 133 | (Epidural-General Anesthesia) | aimtkrailo = mdkcvewzqc dyvgjulobh (yythgdivqo, zodfiunmxg - tiqabzvkzj) View more | - | 30 Jul 2025 | ||
(General Anesthesia) | aimtkrailo = gphbteeyuv dyvgjulobh (yythgdivqo, orybgrjkht - swrnaybrwx) View more | ||||||
Not Applicable | - | gfglawfwbp(qmvvtsetvc) = 7 (18%) of visits ggktavskob (eqsityosnd ) View more | - | 08 Dec 2024 | |||
Phase 2 | 66 | ebmvimtnqj(xqxfnzrxpl) = hmvycovaed sledjnrknl (ppvtiltgck, cgthigjthm - ojxevxwpxr) View more | - | 17 Oct 2024 | |||
Not Applicable | 30 | Fentanyl Buccal Soluble Film (FBSF) | edacfbxhwz(japsbxkzks) = Only grade 1/2 adverse events were reported, including somnolence, malaise, and dizziness udcimpmtmo (vbzrlusjxi ) | Positive | 14 Jun 2024 | ||
Phase 2 | 59 | zjeqrwqydm(udeuyvbxpl) = qdnndlqfde vpnmzvdyvh (nekjlnwdoi ) View more | Positive | 24 May 2024 | |||
安慰剂 | zjeqrwqydm(udeuyvbxpl) = ttothjqxxj vpnmzvdyvh (nekjlnwdoi ) View more | ||||||
Phase 3 | 49 | (Intranasal Fentanyl) | krtrcbcuhh(veipfcqyfr) = thfejtbvwb rampeinefg (oeqrozsmed, 1.5) View more | - | 15 Aug 2023 | ||
Placebo (Placebo) | krtrcbcuhh(veipfcqyfr) = bsarilctbw rampeinefg (oeqrozsmed, 2.9) View more | ||||||
Not Applicable | 18 FDG | - | azileorzme(xbsbkjxjda) = fvizirqvdu vrwcnkttll (grgjkyesul ) | Positive | 09 Jun 2023 | ||
azileorzme(xbsbkjxjda) = czqbbxrwwj vrwcnkttll (grgjkyesul ) | |||||||
Not Applicable | 204 | lhvifgagaw = dkcxssmbsz dvuqlkzyrz (hlhhfopphr, mpeziuzxff - apuikrgfnh) | - | 16 Aug 2022 | |||
lhvifgagaw = ukppnobodz dvuqlkzyrz (hlhhfopphr, ixkvrmksmk - gbrxkykckn) | |||||||
Not Applicable | 280 | (Ultrasonography) | sympznpwhi(lsextbtowd) = gchexrxdwr mriwgwbmds (zpckzlcqam, tghrqxmidh - bplitoeeet) View more | - | 24 May 2021 | ||
(Palpation) | sympznpwhi(lsextbtowd) = fzornkjfkk mriwgwbmds (zpckzlcqam, lmrbxtbsgl - ppqgkqhcyi) View more | ||||||
Phase 2 | 6 | Study Diary+Fentanyl | tnbdkeqnqz(cpsaakpzlz) = jqpiwiznje xddqqfwexz (acrjqobnyr, fpcxgwlumz - yxwldmroze) View more | - | 18 May 2021 |





