Overview
A reversible monoamine oxidase inhibitor (MAOI) selective for isoform A (RIMA) used to treat major depressive disorder. Most meta-analyses and most studies indicate that in the acute management of depression, moclobemide is more efficacious than placebo medication and similarly efficacious as tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors (SSRIs). Due to negligible anticholinergic and antihistaminic actions, moclobemide has been better tolerated than tri- or heterocyclic antidepressants .
Background
A reversible monoamine oxidase inhibitor (MAOI) selective for isoform A (RIMA) used to treat major depressive disorder. Most meta-analyses and most studies indicate that in the acute management of depression, moclobemide is more efficacious than placebo medication and similarly efficacious as tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors (SSRIs). Due to negligible anticholinergic and antihistaminic actions, moclobemide has been better tolerated than tri- or heterocyclic antidepressants .
Indication
For the treatment of major depressive disorder and bipolar disorder .
Associated Conditions
- Major Depressive Disorder (MDD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/01/05 | Phase 2 | Terminated | |||
2015/03/02 | Phase 3 | Terminated | |||
2013/08/21 | Phase 2 | Completed | Jed E. Rose |
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 |
---|---|---|---|---|---|
MOCLOBEMIDE HEXAL TABLET 150mg | SIN13093P | TABLET | 150mg | 4/21/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Moclobemide Capsules | 国药准字H19990322 | 化学药品 | 胶囊剂 | 7/14/2020 | |
Moclobemide Tablets | 国药准字H20000294 | 化学药品 | 片剂 | 2/8/2020 | |
Moclobemide Tablets | 国药准字H20020388 | 化学药品 | 片剂 | 4/19/2021 | |
Moclobemide Tablets | 国药准字H19991138 | 化学药品 | 片剂(薄膜衣) | 7/2/2020 | |
Moclobemide Tablets | 国药准字H20010093 | 化学药品 | 片剂 | 5/11/2024 | |
Moclobemide Tablets | 国药准字H20030145 | 化学药品 | 片剂 | 2/6/2020 |
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 |
---|---|---|---|---|---|
CLOBEMIX moclobemide 150 mg film-coated tablet blister pack | 184084 | Medicine | A | 4/19/2012 | |
MOCLOBEMIDE-ARX moclobemide 150 mg film-coated tablet blister pack | 333640 | Medicine | A | 5/4/2020 | |
MOCLOBIN moclobemide 300 mg film-coated tablet blister pack | 184081 | Medicine | A | 4/19/2012 | |
MOCLOBEMIDE SANDOZ moclobemide 300mg tablet blister pack | 76935 | Medicine | A | 12/7/2000 | |
MOCLOBEMIDE-ARX moclobemide 300 mg film-coated tablet blister pack | 333641 | Medicine | A | 5/4/2020 | |
AURORIX moclobemide 300mg tablet blister pack | 51626 | Medicine | A | 3/15/1995 | |
MOCLOBEMIDE-WGR moclobemide 300 mg film-coated tablet blister pack | 333639 | Medicine | A | 5/4/2020 | |
AURORIX 150mg tablet blister pack | 9987 | Medicine | A | 8/2/1991 | |
CLOBEMIX moclobemide 300 mg film-coated tablet blister pack | 184085 | Medicine | A | 4/19/2012 | |
APO-MOCLOBEMIDE moclobemide 300mg tablet blister pack | 73835 | Medicine | A | 8/17/2000 |