ULTIVA (remifentanil hydrochloride)
Ultiva (remifentanil hydrochloride) is an intravenous opioid agonist indicated for use as an analgesic agent during the induction and maintenance of general anesthesia for both inpatient and outpatient surgical procedures. In adult patients, it is also indicated for use as an analgesic component of monitored anesthesia care (MAC) and for the continuation of analgesia into the immediate postoperative period under the direct supervision of an anesthesia practitioner.
How ULTIVA Works
Ultiva is a $\mu$-opioid agonist characterized by a rapid onset, peak effect, and very short duration of action. Unlike other opioids, remifentanil is rapidly metabolized by hydrolysis via nonspecific blood and tissue esterases rather than by the liver or plasma cholinesterase. This unique metabolic pathway ensures that its duration of action is brief and predictable, even after prolonged infusions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-07-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ULTIVA Approval History
What ULTIVA Treats
1 indicationsULTIVA is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
ULTIVA Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA Addiction, Abuse, and Misuse Because the use of ULTIVA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory d...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA Addiction, Abuse, and Misuse Because the use of ULTIVA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of ULTIVA, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ULTIVA are essential [see Warnings and Precautions (5.2) ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of ULTIVA and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA See full prescribing information for complete boxed warning. • ULTIVA exposes users to the risks of addiction, abuse, and misuse. Assess patient’s risk before prescribing and reassess regularly for the development of these behaviors and conditions.(5.1) • Serious, life-threatening, or fatal respiratory depression may occur with use of ULTIVA, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ULTIVA are essential. ( 5.2 ) • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and
ULTIVA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ULTIVA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05391555 results posted | 21-34917 | Ph 2, Ph 3 | completed | Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age |
| NCT03167905 CODEPAD | 2017/2090 | Ph 2, Ph 3 | active not recruiting | CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery) |
| NCT02967029 | IstanbulUn | Ph 4 | completed | Effect of Controlled Hypotension on Cerebral Oxygen Saturation |
| NCT02566733 | Remifentanil_CPB | Ph 4 | completed | Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ULTIVA FDA Label Details
Indications & Usage
FDA Label (PDF)ULTIVA is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA Addiction, Abuse, and Misuse Because the use of ULTIVA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reasse...
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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