Friday, July 10, 2026

Drug profile · INN

fentanyl

fentanyl (ABSTRAL) is a mu opioid receptor agonist. Associated with Apotex Pty Ltd. Route of administration: buccal. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N02) N02AB03
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — fentanyl
US status
approved
Class
Nervous system (N02)
Route
BUCCAL
Patents
0
Programs
5
Data quality
0.84

Quick answer

fentanyl (ABSTRAL) is a mu opioid receptor agonist. Associated with Apotex Pty Ltd. Route of administration: buccal. Current US regulatory status: approved.

Key facts

INN fentanyl
Brand ABSTRAL
Mechanism Mu opioid receptor agonist
Target Mu-type opioid receptor
Therapeutic class Nervous system (N02)
Route BUCCAL
Formulation SPRAY
ATC code N02AB03
Originator Apotex Pty Ltd

Mechanism of action

Mu opioid receptor agonist

Primary target: Mu-type opioid receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. CLP22001 Phase 1 · Alphapharm · Bioequivalence trial in healthy volunteers
  2. CLP24001 Phase 1 · Alphapharm · Bioequivalence trial in healthy volunteers
  3. Duragesic reference fentanyl TDS Approved · BRIGHT MINDS BIOSCIENCES · Peer Review, Research
  4. Fentanyl hameln 50 microgram/ml for healthy volunteers, opioid use… Approved · Disc Medicine · healthy volunteers, opioid use disorder
  5. fentanyl Unknown · Hospital Authority · Anesthesia, Spinal

Related & competitor drugs

  1. alvimopan Mu opioid receptor antagonist
  2. aripiprazole Nervous system (N05)
  3. brexpiprazole Nervous system (N05)
  4. brivaracetam Nervous system (N03)
  5. bupivacaine Nervous system (N01)
  6. buprenorphine Nervous system (N07)

Frequently asked questions

What is fentanyl?

fentanyl (ABSTRAL) is a mu opioid receptor agonist. Associated with Apotex Pty Ltd. Route of administration: buccal. Current US regulatory status: approved.

What is the brand name for fentanyl?

ABSTRAL is a marketed brand name for fentanyl. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fentanyl?

fentanyl has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.