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Sulfentanyl

Shenzhen Third People's Hospital · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 32/100

Sulfentanyl is a Small molecule drug developed by Shenzhen Third People's Hospital. It is currently in Phase 1 development for General anesthesia, Postoperative pain. Also known as: sulfentanil.

Sulfentanyl is a medication that has been studied in clinical trials for various conditions, including sedation and colon cancer, and has been compared to other anesthetics such as etomidate and propofol. The exact mechanism of action of sulfentanyl is not specified in the provided facts, but it is likely related to its opioid receptor activity as indicated by its presence in ChEMBL.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameSulfentanyl
Also known assulfentanil
SponsorShenzhen Third People's Hospital
TargetSolute carrier family 22 member 1, Delta-type opioid receptor, Kappa-type opioid receptor
ModalitySmall molecule
Therapeutic areaPain
PhasePhase 1

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Sulfentanyl

What is Sulfentanyl?

Sulfentanyl is a Small molecule drug developed by Shenzhen Third People's Hospital, indicated for General anesthesia, Postoperative pain.

What is Sulfentanyl used for?

Sulfentanyl is indicated for General anesthesia, Postoperative pain.

Who makes Sulfentanyl?

Sulfentanyl is developed by Shenzhen Third People's Hospital (see full Shenzhen Third People's Hospital pipeline at /company/shenzhen-third-people-s-hospital).

Is Sulfentanyl also known as anything else?

Sulfentanyl is also known as sulfentanil.

What development phase is Sulfentanyl in?

Sulfentanyl is in Phase 1.

What are the side effects of Sulfentanyl?

Common side effects of Sulfentanyl include apnea, pain, hypotension, COVID, DVT, bladder spasms.

What does Sulfentanyl target?

Sulfentanyl targets Solute carrier family 22 member 1, Delta-type opioid receptor, Kappa-type opioid receptor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing