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Peripheral intravenous norepinephrine
Peripheral intravenous norepinephrine is a Catecholamine vasopressor Small molecule drug developed by University Hospital, Bordeaux. It is currently in Phase 3 development for Hypotension in acute care / septic shock (peripheral administration), Cardiogenic shock.
Norepinephrine is a catecholamine that binds to alpha and beta adrenergic receptors to increase blood pressure and cardiac output, used peripherally to treat hypotension.
Norepinephrine is a catecholamine that binds to alpha and beta adrenergic receptors to increase blood pressure and cardiac output, used peripherally to treat hypotension. Used for Hypotension in acute care / septic shock (peripheral administration), Cardiogenic shock.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 name | Peripheral intravenous norepinephrine |
|---|---|
| Sponsor | University Hospital, Bordeaux |
| Drug class | Catecholamine vasopressor |
| Target | Alpha-1 adrenergic receptor, Beta-1 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular / Critical Care |
| Phase | Phase 3 |
Mechanism of action
Norepinephrine acts as a sympathomimetic agent, stimulating alpha-1 adrenergic receptors to cause vasoconstriction and beta-1 adrenergic receptors to increase heart rate and contractility. When administered via peripheral intravenous line (rather than central line), this represents a clinical approach to managing hypotensive states in acute care settings, though peripheral administration carries higher risk of extravasation injury.
Approved indications
- Hypotension in acute care / septic shock (peripheral administration)
- Cardiogenic shock
Common side effects
- Extravasation injury / tissue necrosis
- Hypertension
- Tachycardia
- Arrhythmias
- Headache
Key clinical trials
- Early Vasopressors in Sepsis (PHASE3)
- Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery (PHASE3)
- Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2 (NA)
- Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine (PHASE3)
- Early Administration of Norepinephrine in Sepsis (PHASE4)
- Diastolic Performance and Norepinephrine in Spinal-Induced Hypotension for Cesarean Delivery
- Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly (PHASE2, PHASE3)
- Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- Peripheral intravenous norepinephrine CI brief — competitive landscape report
- Peripheral intravenous norepinephrine updates RSS · CI watch RSS
- University Hospital, Bordeaux portfolio CI
Frequently asked questions about Peripheral intravenous norepinephrine
What is Peripheral intravenous norepinephrine?
How does Peripheral intravenous norepinephrine work?
What is Peripheral intravenous norepinephrine used for?
Who makes Peripheral intravenous norepinephrine?
What drug class is Peripheral intravenous norepinephrine in?
What development phase is Peripheral intravenous norepinephrine in?
What are the side effects of Peripheral intravenous norepinephrine?
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Related
- Drug class: All Catecholamine vasopressor drugs
- Target: All drugs targeting Alpha-1 adrenergic receptor, Beta-1 adrenergic receptor
- Manufacturer: University Hospital, Bordeaux — full pipeline
- Therapeutic area: All drugs in Cardiovascular / Critical Care
- Indication: Drugs for Hypotension in acute care / septic shock (peripheral administration)
- Indication: Drugs for Cardiogenic shock
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing