Overview

Reboxetine is an antidepressant drug used in the treatment of clinical depression, panic disorder and ADD/ADHD. Its mesylate (i.e. methanesulfonate) salt is sold under tradenames including Edronax, Norebox, Prolift, Solvex, Davedax or Vestra. Reboxetine has two chiral centers, but it only exists as two enantiomers, (R,R)-(-)- and (S,S)-(+)-reboxetine.

Indication

For the treatment of clinical depression.

Associated Conditions

Major Depressive Disorder (MDD)

Research Report

Published: Jun 10, 2025

Comprehensive Analysis of CampETEC: An Investigational Therapeutic for Enteric Diseases

1. Executive Summary

CampETEC is an orally administered, investigational hyperimmune bovine colostrum (HBC) product developed by Immuron Ltd., primarily targeting the prevention of diarrhea caused by Campylobacter bacteria, and with potential activity against Enterotoxigenic Escherichia coli (ETEC) based on the immunizing vaccine used in recent trials. Its development involves significant collaboration, notably with the U.S. Naval Medical Research Command (NMRC), which sponsored and conducted a key Phase II Controlled Human Infection Model (CHIM) study (NCT06122870). This study aimed to assess the safety and efficacy of CampETEC in preventing campylobacteriosis.

The therapeutic rationale for CampETEC is rooted in the substantial global burden of enteric diseases caused by Campylobacter and ETEC, which affect travelers, military personnel, and particularly children in low- and middle-income countries, where such infections can lead to severe complications, including malnutrition and developmental issues. CampETEC employs a passive immunotherapy approach, delivering polyclonal antibodies derived from the colostrum of cows vaccinated with specific bacterial antigens. In the NMRC trial, these antigens were from a conjugated vaccine targeting the Campylobacter jejuni capsule and an ETEC colonization factor.

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Reboxetine for Sleep Apnoea After ENT Surgery	2023/08/07	NCT05978505	Phase 2	Recruiting	Flinders University
The Role of the Brain in Mental and Physical Fatigue	2023/05/30	NCT05880342	Phase 3	Recruiting	Vrije Universiteit Brussel
Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD	2021/11/24	NCT05133804	Phase 2	Recruiting	University of Haifa
Studying the Role of Brain Molecules for Decision Making	2020/05/12	NCT04384562	Not Applicable	Completed	University of Zurich
The Role of Dopaminergic and Noradrenergic Neurotransmission in Value- and Salience-based Decision-Making	2020/05/01	NCT04371146	Not Applicable	Completed	University of Zurich
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	2019/09/20	NCT04097288	Phase 1	Completed	University Hospital Bispebjerg and Frederiksberg
Noradrenaline, Acetylcholine and Dynamic Learning in Healthy Humans	2019/05/21	NCT03957174	Not Applicable	Completed	University of Oxford
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Antidepressants and Bone Mineral Density	2014/07/01	NCT02179268	Phase 3	Completed	Guiyang Medical University
Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia	2011/02/21	NCT01300364	Phase 4	UNKNOWN	Fundació Sant Joan de Déu

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EDRONAX reboxetine 4mg (as mesilate) tablet blister pack	79745	Pfizer Australia Pty Ltd	Medicine	A	8/24/2001

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
IRENOR 4 mg COMPRIMIDOS	Pfizer S.L.	63157	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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Reboxetine