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
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.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/08/07 | Phase 2 | Recruiting | |||
2023/05/30 | Phase 3 | Recruiting | |||
2021/11/24 | Phase 2 | Recruiting | |||
2020/05/12 | Not Applicable | Completed | |||
2020/05/01 | Not Applicable | Completed | |||
2019/09/20 | Phase 1 | Completed | University Hospital Bispebjerg and Frederiksberg | ||
2019/05/21 | Not Applicable | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/07/01 | Phase 3 | Completed | Guiyang Medical University | ||
2011/02/21 | Phase 4 | UNKNOWN |
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 |
|---|---|---|---|---|---|
| Reboxetine Mesylate Capsules | 国药准字H20041010 | 化学药品 | 胶囊剂 | 4/14/2020 | |
| Reboxetine Mesilate Tablets | 国药准字H20080557 | 化学药品 | 片剂 | 3/23/2023 | |
| Reboxetine Mesilate Tablets | 国药准字H20051833 | 化学药品 | 片剂 | 8/30/2020 | |
| Reboxetine Mesilate Tablets | 国药准字H20080155 | 化学药品 | 片剂 | 12/13/2022 |
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 | Medicine | A | 8/24/2001 |
Help Us Improve
Your feedback helps us provide better drug information and insights.