Data updated: May 26, 2026
NOREPINEPHRINE BITARTRATE
Trial Activity: Mature 12 active trials
Cardiovascular
Approved 2003-03-03
Norepinephrine bitartrate is a catecholamine used to raise blood pressure in adults experiencing severe, acute hypotension. It helps patients in acute hypotensive states by restoring blood pressure to more stable levels. This medication is typically used in critical situations where a rapid increase in blood pressure is necessary.
Source: FDA Label • RISING
How NOREPINEPHRINE BITARTRATE Works
This drug works by acting as a peripheral vasoconstrictor through alpha-adrenergic activity to narrow blood vessels. It also provides beta-adrenergic action, which stimulates the heart and dilates the coronary arteries. Together, these actions help restore blood pressure and improve circulation to the heart muscle.
Source: FDA Label
Development Insights
Centre Hospitalier Universitaire, Amiens conducting 3 trials (5%)
79 indications explored (Broad Platform)
→ septic shock (7 trials)
→ hypotension (7 trials)
→ cesarean section complications (7 trials)
19
Indications
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Prescription
- First Approved
- 2003-03-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
RISING Novartis Sun Pharma BRECKENRIDGE MSN Viatris ZYDUS PHARMS CAPLIN BIOCON PHARMA Hikma GLAND Baxter ANTHEA PHARMA MEITHEAL AMNEAL Fresenius Kabi ASPIRO METRICS PHARM
Active Ingredient: NOREPINEPHRINE BITARTRATE
Website: ↗
NOREPINEPHRINE BITARTRATE Approval History
2004
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2018
2019
2020
2021
2022
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Original
New Indication
New Form
Label Update
26 FDA actions from 2003 to 2025
Dec 2025 ORIGINAL
Update
Nov 2025 ORIGINAL
Update
Mar 2025 ORIGINAL
Update
Jan 2025 ORIGINAL
Update
May 2024 ORIGINAL
Update
Sep 2023 ORIGINAL
Update
Jul 2022 ORIGINAL
Update
May 2021 ORIGINAL
Update
Apr 2021 SUPPL
Label
Feb 2021 SUPPL
Label
Jan 2021 ORIGINAL
Update
Jan 2021 ORIGINAL
Update
Nov 2020 ORIGINAL
Update
Oct 2020 SUPPL
Label
Sep 2020 SUPPL
Label
Aug 2020 SUPPL
Label
Dec 2018 ORIGINAL
Update
Nov 2018 ORIGINAL
Update
Oct 2018 ORIGINAL
Update
Oct 2018 ORIGINAL
Update
Aug 2015 SUPPL
Mfg
Mar 2012 ORIGINAL
Update
Sep 2004 ORIGINAL
Update
Oct 2003 ORIGINAL
Update
Mar 2003 ORIGINAL
Update
What NOREPINEPHRINE BITARTRATE Treats
1 indicationsNOREPINEPHRINE BITARTRATE is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypotension
Source: FDA Label
NOREPINEPHRINE BITARTRATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
9
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
8
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
8
Same indication, different mechanism — what else might this patient receive?
Unlock 19 more competitors across all three rings.
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Drugs Similar to NOREPINEPHRINE BITARTRATE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
57 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06746753 MANTRA | IRB00115287 R01HL177834 | Ph 4 | not yet recruiting | Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock |
| NCT06802224 VEGA-2 | 23-39683 R01DK139484 | Ph 4 | recruiting | The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery |
| NCT05179499 EVIS | GN20AE342 2021-006886-39 | Ph 3 | recruiting | Early Vasopressors in Sepsis |
| NCT07322133 DONE | 2339428 GFDS25 | Ph 4 | recruiting | Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE) |
| NCT06344442 | APHP220827 | Ph 3 | recruiting | Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial) |
| NCT07327320 NORPHE-CD | TA2.24.03 | Ph 4 | completed | Norepinephrine vs. Phenylephrine for Hypotension in Low-Dose Spinal Anesthesia for Cesarean Delivery |
| NCT02118467 | 14-0047 | Ph 4 | recruiting | Vasoactive Drugs in Intensive Care Unit |
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT06921473 NEO-FET | GYEAH-OB-NE-EF-001 | Ph 4 | completed | Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia |
| NCT05568160 NOVACC | GUINOT PHRCI 2019 | Ph 3 | active not recruiting | Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation |
| NCT04789330 VEGA-1 results posted | A135759 | Ph 4 | completed | Norepinephrine vs Phenylephrine During General Anesthesia |
| NCT01426529 | 2010P002187 1R01HL104032-01 | Ph 1 | active not recruiting | Caveolin-1 and Vascular Dysfunction |
| NCT05276596 EPON | PI2021_843_0060 | Ph 3 | completed | Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction |
| NCT02473263 SSS | 2014-A01030-47 | Ph 3 | completed | Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock |
| NCT02479529 SNEAD | PI2014_843_0014 2014-002707-22 | Ph 3 | completed | Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative. |
| NCT04592744 | 20-001402 | Ph 4 | enrolling by invitation | Angiotensin 2 for AKI After OLT |
| NCT05264870 | 002105 | Ph 4 | terminated | Norepinephrine in Caesarian Section |
| NCT04934748 | HSC-MS-24-1026 (vasopressor) | Ph 4 | enrolling by invitation | The GUARDIAN Trial - Vasopressor Sub-Study |
| NCT06574555 | 240816002 | Ph 4 | completed | Norepinephrine ED90 Bolus After Spinal Anesthesia in Cesarean Section |
| NCT06496061 | M728 | Ph 4 | completed | Leg Wrapping and Norepinephrine for Prevention of Post Spinal Hypotension in C.S |
| NCT06977659 ENTHeS | MURA2025/335 | Ph 1, Ph 2 | enrolling by invitation | Early Norepinephrine in Trauma Patients With Hemorrhagic Shock |
| NCT04501861 results posted | 20-301 | Ph 3 | completed | Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: |
| NCT05836272 EA-NE-TUN | Tunisian ICUs association | Ph 4 | recruiting | Early Administration of Norepinephrine in Sepsis |
| NCT03864094 VH | 2019/374 2019-000965-19 | Ph 4 | completed | Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine. |
| NCT05355974 RAPID PRESS | IRB-2022-43 IRB-2022-43 | Ph 3 | completed | Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure |
| NCT06498115 | 2024-k21 | Ph 4 | recruiting | Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia |
| NCT05521152 | MD-12-2021 | Ph 3 | completed | Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy |
| NCT06461390 | 23-12-2106 | Ph 2, Ph 3 | completed | The Effect of Early Norepinephrine on Stroke Volume Index, Cardiac Index, Lactate, and Arterial Elastance in Pediatric Septic Shock |
| NCT03483753 VANCSIII | 62586316.6.0000.0065 | Ph 2, Ph 3 | withdrawn | Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery |
| NCT03965117 | 2019/0395 | Ph 4 | completed | Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy. |
| NCT05368415 | Levo bolus in CS | Ph 4 | completed | Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia |
| NCT04991662 | SFY2021-HZ08-11 | Ph 4 | completed | Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery |
| NCT04536194 | mzk-0003-2020 | Ph 3 | completed | Dopamine Versus Norepinephrine Under General Anesthesia |
| NCT04195321 | D-7-2019 | Ph 4 | completed | Norepinephrine Versus Phenylephrine for Preventing Spinal Anesthesia Induced Hypotension in Elderly |
| NCT03849508 PHENAD | CHRO-2018-10 | Ph 4 | completed | Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia |
| NCT04789005 | 439/(6-11)E²/076/077 | Ph 3 | completed | Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension |
| NCT03806582 | TPO 1051 | Ph 4 | completed | Effect of a Higher Blood-pressure on Right Ventricular Function |
| NCT03833895 | CINI-AD-201812-3 | Ph 2, Ph 3 | completed | The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section |
| NCT03163914 | Vasopressor | Ph 4 | completed | Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension |
| NCT03302650 | N-68-2017 | Ph 3 | suspended | Angiotensin II for Septic Shock Treatment |
| NCT03328533 | N-82-2017 | Ph 4 | completed | Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery |
| NCT02203630 results posted | IRB 140141 UL1RR024975-01, UL1TR000445-06 | Ph 4 | terminated | Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients |
| NCT01718613 VANCS II | NP 1079/17 | Ph 3 | completed | Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients |
| NCT02428062 THE BRIDGE | TB-POCD | Ph 2, Ph 3 | suspended | Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly |
| NCT02085291 | 2014ZDll.2 Targeting microcirculation | Ph 4 | completed | Effect of Different Strategies for Titrating a High MAP on Microcirculation |
| NCT03215797 | Ph Vs N in SVV GDT | Ph 3 | completed | Phenylephrine or Norepinephrine for a Better Hemodynamic Stability |
| NCT02454348 NOVEL | 204265 | Ph 4 | withdrawn | NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock |
| NCT02477501 | UTEM NAD | Ph 4 | completed | Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section |
| NCT02854787 NorPN | UniversityTunis el manar | Ph 4 | completed | Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia |
| NCT03015857 | cesarean sections | Ph 2 | completed | Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension |
Showing 50 of 57 trials
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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.
NOREPINEPHRINE BITARTRATE FDA Label Details
Indications & Usage
NOREPINEPHRINE BITARTRATE is indicated for the treatment of Hypotension.
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Full clinical data, patents, trials, and competitive landscape for norepinephrine bitartrate.
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