Data updated: May 26, 2026
DSUVIA (sufentanil citrate)
Trial Activity: Mature 11 active trials
Pain
Approved 2018-11-02
Development Insights
Peking University First Hospital conducting 3 trials (6%)
72 indications explored (Broad Platform)
→ pain (4 trials)
→ pain, postoperative (3 trials)
→ acute pain (3 trials)
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-11-02
- Patent Cliff
- 2038
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
DSUVIA Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2018 to 2025
What DSUVIA Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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Clinical Trial Registry
52 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06784999 | 21583 | Ph 4 | recruiting | Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction |
| NCT05072704 OFATHA | 2021/04 | Ph 3 | completed | Opioid Free Anesthesia in Total Hip Arthroplasty |
| NCT05446623 OFFLOW | 2020-A02873-36 | Ph 2, Ph 3 | completed | Cardiac Index and General Anesthesia Without Opioid. |
| NCT07018375 | IRB2025-YX-199-01 | Ph 4 | not yet recruiting | The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy |
| NCT00577200 MACDrive | ABuv110507 | Ph 4 | active not recruiting | Safety of Driving After Minor Surgery With Monitored Anesthesia Care |
| NCT02962830 2IAS | 2014_19 2015-001721-16 | Ph 2 | completed | Sufentanil Pharmacokinetics After Intra Amniotic Injection |
| NCT03726268 OSPREy results posted | Pro00089977 1R01DA042985-01 | Ph 4 | completed | Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement) |
| NCT06530563 | XiangyaHMZK | Ph 4 | not yet recruiting | the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery |
| NCT02095366 ALGOFINE-2 | ALGOFINE-2 | Ph 4 | completed | Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting |
| NCT05718544 | 2023-017 | Ph 4 | completed | Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes |
| NCT07026162 | LYEC2024-0425 | Ph 4 | recruiting | Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery |
| NCT04959812 results posted | STU-2021-0579 | Ph 1, Ph 2 | completed | Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil |
| NCT06958393 | opioid-free anaesthesia | Ph 4 | not yet recruiting | Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery |
| NCT05831345 | CHUB-Methadone | Ph 3 | recruiting | Intraoperative Methadone for the Prevention of Postoperative Pain |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT05826327 | IRB-20230021-R | Ph 4 | recruiting | Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients |
| NCT04396587 | NAESHO | Ph 4 | completed | Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone |
| NCT05750056 | K2020-05-029-02 | Ph 4 | completed | Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection |
| NCT06037330 | QFSYXLL-KY-2022(092) | Ph 4 | recruiting | Nalbuphine in ARDS Patients After Surgery |
| NCT06041425 | 2023-SR-093 | Ph 4 | completed | The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE |
| NCT06232785 | 2021/018 | Ph 4 | completed | Gynecologic Endoscopic Surgery of Female Motion Sickness Patients |
| NCT05698407 | 2022-368 | Ph 4 | completed | Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia |
| NCT06181695 INVOPE | APHP211035 | Ph 3 | not yet recruiting | Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric |
| NCT04561375 results posted | 20-642 | Ph 4 | terminated | Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery |
| NCT05508594 | PDC 01-0205 | Ph 2, Ph 3 | completed | Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 |
| NCT04716413 results posted | 2021-12649 | Ph 4 | terminated | Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment |
| NCT05901441 | MCHH_002 | Ph 2 | completed | Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia |
| NCT02989597 MAPS results posted | 2016-6985 | Ph 4 | terminated | Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients |
| NCT04791059 | 2020-465 | Ph 4 | completed | Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia |
| NCT04464512 SUPER-ERAS | 1802003669 | Ph 4 | withdrawn | Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population |
| NCT02573597 results posted | 34734 | Ph 4 | terminated | PIEB vs CEI for Labor Analgesia: An MLAC Study |
| NCT05576675 | xijingHospital | Ph 3 | completed | Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery |
| NCT04807335 | PDC 01-0204 | Ph 1 | completed | Study of CT001 in Healthy Volunteers |
| NCT02741219 | OBGynFudanU | Ph 4 | completed | A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section |
| NCT04443946 | CINI-AD-20205-19 | Ph 4 | completed | Different Anesthesia Maintain Protocol Effect the Outcome of the Patients |
| NCT03036384 results posted | NB076201627436 | Ph 2 | completed | Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery |
| NCT03901716 | Opioid2019 | Ph 4 | completed | Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation |
| NCT02857465 DEXAPER | 2015/CHU/12 | Ph 3 | withdrawn | Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome |
| NCT02563821 PCEA-IMG | I14032 (PCEA-IMG) | Ph 3 | completed | Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG) |
| NCT01012999 results posted | 32225 | Ph 1, Ph 2 | terminated | A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain |
| NCT00656773 | 07 139 03 N° EUDRACT 2007-004049-14 | Ph 3 | completed | A Randomized, Double-blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain |
| NCT01356732 REANURSUF | 09 162 02 | Ph 4 | completed | Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients |
| NCT01954368 InSPEED | 13-AOI-10 2013-003308-38 | Ph 4 | completed | Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay |
| NCT00772616 | 2007/13 | Ph 4 | completed | Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption |
| NCT01320475 | 2009/04 | Ph 4 | terminated | Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine |
| NCT02544282 | GZA-ANE-PECS-01 | Ph 4 | completed | Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery |
| NCT00943566 | STDS0901 | Ph 2 | withdrawn | A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer |
| NCT02053818 PRECON2 | 2010-022428-58 | Ph 4 | completed | Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers. |
| NCT01777100 SAIRA | UNESP | Ph 4 | completed | Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia |
| NCT01235637 DOLOREAPEDIA | DCIC 10 10 | Ph 3 | completed | Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction |
Showing 50 of 52 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DSUVIA FDA Label Details
View full patent landscape →
21 OB patents · 8 families ·
129 international docs across 20 countries
DSUVIA Patents & Exclusivity
Latest Patent: Feb 2038
Patents (21 active)
US11672738
Expires Feb 2, 2038
US8945592
Expires Jul 29, 2031
US8202535
Expires Oct 22, 2030
US8865743
Expires Oct 22, 2030
US12033733
Expires Mar 16, 2030
US10896751
Expires Mar 16, 2030
US8574189
Expires Mar 16, 2030
US11676691
Expires Mar 16, 2030
US8778393
Expires Jan 5, 2027
US9320710
Expires Jan 5, 2027
US8226978
Expires Jan 5, 2027
US8865211
Expires Jan 5, 2027
US10245228
Expires Jan 5, 2027
US10507180
Expires Jan 5, 2027
US8535714
Expires Jan 5, 2027
US8778394
Expires Jan 5, 2027
US9744129
Expires Jan 5, 2027
US8252329
Expires Jan 5, 2027
US10342762
Expires Jan 5, 2027
US8252328
Expires Jan 5, 2027
US8231900
Expires Jan 5, 2027
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for DSUVIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 21 active patents
Trial Analysis
- • 51 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment