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Drug

Sufentanil citrate

Approved · FDA / EMA
Late-stage development
Also known as Sufenta, Fentathienil citrate, Sufentanyl citrate, Sulfentanil citrate+2 more

Sufenta, Fentathienil citrate, Sufentanyl citrate, Sulfentanil citrate, Sulphentanil citrate, sufentanil (as citrate).

RxNorm58964
4
Active clinical trials
11
Regulatory events
Latest activity
beta

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

Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Function in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial

Clinical trial2026-06-25Results expected Q3 2026 · ClinicalTrials.gov

Label change: SUFENTANIL CITRATE (ANDA074534)

Regulatory2026-06-25FDA

the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery: a Randomized, Double-blind, Positive-drug Parallel-controlled, Multi-center Clinical Study

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

Label change: SUFENTANIL CITRATE (ANDA074534)

Regulatory2024-08-22FDA

Label change: SUFENTANIL CITRATE (ANDA074534)

Regulatory2024-01-26FDA

The Safety and Efficacy of Long-term-opioid-free Anesthesia in Anterior Cervical Surgery: a Prospective Randomized Controlled Trial

Clinical trial2023-12-31Completed · ClinicalTrials.gov

Label change: SUFENTANIL CITRATE (ANDA074534)

Regulatory2021-06-25FDA

Label change: SUFENTANIL CITRATE (ANDA074534)

Regulatory2021-06-25FDA

Whether Opioids Are Factor That Induced Postoperative Delirium?

Clinical trial2020-12-31Completed · ClinicalTrials.gov

Approval: Dzuveo (EMA)

Regulatory2018-06-25EMA

Profile

Identifiers & mechanism

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

Canonical name
Sufentanil citrate
Aliases & brands
SufentaFentathienil citrateSufentanyl citrateSulfentanil citrateSulphentanil citratesufentanil (as citrate)
RxNorm CUI
58964
Regulatory jurisdictions
emafda

Regulatory timeline

11 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.

Earliest approval
1996-12-11
Latest approval
2018-06-25
Authorities
FDA · EMA
Total events
11
fdaU.S. Food and Drug Administration· 10 events
2026-06-25Label change
Label change: SUFENTANIL CITRATE (ANDA074534)
Evidence ↗
2024-08-22Label change
Label change: SUFENTANIL CITRATE (ANDA074534)
Evidence ↗
2024-01-26Label change
Label change: SUFENTANIL CITRATE (ANDA074534)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2018-06-25Approval
Approval: Dzuveo (EMA)

Indication: Dzuveo is indicated for the management of acute moderate to severe pain in adult patients.

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

7 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
7
registered trials across all phases
LATEST COMPLETION 2023
4
Active studies
4
Recruiting
7
Late-stage (III+)
3
Completed
PHASE DISTRIBUTIONn = 7
Phase 31Phase 43Phase N / A3

Late-stage studies

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

the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery: a Randomized, Double-blind, Positive-drug Parallel-controlled, Multi-center Clinical Study

Not yet recruitingPH IVXiangya Hospital of Central South Universityn=6062026

Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial

Enrolling by invitationPH IVWest China Hospitaln=5702025

Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries

CompletedPH IVNanjing Medical Universityn=1502009

Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery

RecruitingPH IIIBrugmann University Hospitaln=802025
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.