> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/paroxetine-mesylate-055a4ce3-159c-459a-a88a-ad9e1fd56185 > Record changed: 2026-10-13 # Paroxetine mesylate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) First approval year 2003 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) ## Development status **First approval year** 2003 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) **Drug name** Paroxetine mesylate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) **Molecular weight** 425.48 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) **Structure (SMILES)** CS(=O)(=O)O.Fc1ccc(\[C@@H\]2CCNC\[C@H\]2COc2ccc3c(c2)OCO3)cc1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) ### Brand names (4) - brisdelle - Brisdelle - pexeva - Pexeva ### Other names (28) - (-)-TRANS-4R-(4'-FLUOROPHENYL)-3S-((3',4'-METHYLENEDIOXYPHENOXY)METHYL)PIPERIDINE, MESILATE - (-)-TRANS-4R-(4'-FLUOROPHENYL)-3S-((3',4'-METHYLENEDIOXYPHENOXY)METHYL)PIPERIDINE, MESYLATE - mesafem - Mesafem - paroxetine mesilate - Paroxetine mesilate - PAROXETINE MESILATE \[MART.\] - Paroxetine mesilate \[WHO-DD\] - paroxetine mesilate mart - paroxetine mesilate who dd - paroxetine mesylate - Paroxetine mesylate - PAROXETINE MESYLATE \[ORANGE BOOK\] - PAROXETINE MESYLATE \[USAN\] - paroxetine mesylate orange book - paroxetine mesylate usan - paroxetine methanesulfonate - Paroxetine methanesulfonate - PAROXETINE METHANESULFONATE \[MI\] - paroxetine methanesulfonate mi - paroxetine methanesulphonate - Paroxetine methanesulphonate - po t mes - PO-T.MES - pot mes And 3 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 217797-14-3 **ChEMBL ID** CHEMBL1200609 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) **InChIKey** SHIJTGJXUHTGGZ-RVXRQPKJSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200609) **FDA ingredient codes (UNII)** - M711N184JE ### PubChem compound IDs (2) - 9845306 - 11407639 ### RxNorm IDs (RxCUI) (2) - 235830 - 436212 ## Regulatory information ### United States **Applicant** LEGACY **Approval date** 28 Jun 2013 **Application number** NDA204516 ### Other regulatory facts **Patents** 3 **Designations** 0 **Earliest recorded loss of exclusivity** 6 Apr 2029 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Drug name stem** \-oxetine #### Administration routes - Oral ### Mechanisms of action - **Mechanism** Serotonin transporter inhibitor **Action type** Inhibitor **Target** Sodium-dependent serotonin transporter **Protein identifier** P31645 ### Open Targets mechanisms - **Mechanism** Serotonin transporter inhibitor **Action type** Inhibitor **Target** Sodium-dependent serotonin transporter ### Investigated indications (8) - **Condition** Stress Disorders, Post-Traumatic **Highest recorded phase** 4 **Condition identifier** EFO:0001358 **Subject identifier** D013313 - **Condition** Obsessive-Compulsive Disorder **Highest recorded phase** 4 **Condition identifier** EFO:0004242 **Subject identifier** D009771 - **Condition** Panic Disorder **Highest recorded phase** 4 **Condition identifier** EFO:0004262 **Subject identifier** D016584 - **Condition** Anxiety Disorders **Highest recorded phase** 4 **Condition identifier** EFO:0006788 **Subject identifier** D001008 - **Condition** Phobia, Social **Highest recorded phase** 4 **Condition identifier** EFO:1001917 **Subject identifier** D000072861 - **Condition** Menopause **Highest recorded phase** 4 **Condition identifier** GO:0042697 **Subject identifier** D008593 - **Condition** Hot Flashes **Highest recorded phase** 3 **Condition identifier** HP:0031217 **Subject identifier** D019584 - **Condition** Depressive Disorder, Major **Highest recorded phase** 4 **Condition identifier** MONDO:0002009 **Subject identifier** D003865 ### Open Targets indications (15) - **Condition identifier** EFO\_0001358 - **Condition identifier** EFO\_0004242 - **Condition identifier** EFO\_0004262 - **Condition identifier** EFO\_0006788 - **Condition identifier** EFO\_1001917 - **Condition identifier** GO\_0042697 - **Condition identifier** GO\_0042697 **Highest recorded phase** 4 - **Condition identifier** HP\_0031217 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0001247 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0002009 - **Condition identifier** MONDO\_0002009 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005146 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005383 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005618 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0008114 **Highest recorded phase** 4 ### Warnings - **Warning** Black Box Warning **Effect** psychiatric toxicity ### Open Targets warnings - **Warning** Black Box Warning **Effect** psychiatric toxicity **Country** United States ### Reported adverse events (47) - **Event** aggression **Reports** 104 **Reporting signal score** 117.865 - **Event** agitation **Reports** 182 **Reporting signal score** 221.353 - **Event** agoraphobia **Reports** 21 **Reporting signal score** 75.1559 - **Event** anxiety **Reports** 225 **Reporting signal score** 163.036 - **Event** atrial septal defect **Reports** 56 **Reporting signal score** 100.531 - **Event** bradykinesia **Reports** 30 **Reporting signal score** 60.114 - **Event** bradyphrenia **Reports** 68 **Reporting signal score** 164.311 - **Event** cardiopulmonary failure **Reports** 27 **Reporting signal score** 93.9565 - **Event** clonus **Reports** 36 **Reporting signal score** 89.97 - **Event** coma **Reports** 165 **Reporting signal score** 249.913 - **Event** confusional state **Reports** 275 **Reporting signal score** 278.618 - **Event** delirium **Reports** 67 **Reporting signal score** 56.3207 - **Event** depression **Reports** 169 **Reporting signal score** 87.6725 - **Event** disorientation **Reports** 79 **Reporting signal score** 80.5005 - **Event** disturbance in attention **Reports** 78 **Reporting signal score** 85.3862 - **Event** drug abuse **Reports** 399 **Reporting signal score** 848.463 - **Event** drug interaction **Reports** 357 **Reporting signal score** 336.67 - **Event** drug withdrawal syndrome **Reports** 132 **Reporting signal score** 183.972 - **Event** dyskinesia **Reports** 59 **Reporting signal score** 55.5348 - **Event** dystonia **Reports** 50 **Reporting signal score** 66.3102 - **Event** electrocardiogram qt prolonged **Reports** 108 **Reporting signal score** 119.549 - **Event** emotional disorder **Reports** 41 **Reporting signal score** 58.429 - **Event** extrapyramidal disorder **Reports** 83 **Reporting signal score** 143.557 - **Event** fall **Reports** 217 **Reporting signal score** 70.2805 - **Event** hallucination, auditory **Reports** 49 **Reporting signal score** 69.2265 And 22 more, listed on the interactive page. ### Trial references (4) - NCT00786188 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00786188) - NCT01101841 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01101841) - NCT01361308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01361308) - NCT01829919 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01829919) ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 1 **Polar surface area** 39.72 **Calculated partition coefficient (ALogP)** 3.33 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 4 **Heavy atoms** 29 **Molecular formula** C20H24FNO6S **Monoisotopic mass** 425.13083682 **Natural product** No ## National Drug Codes - 0574-0279 - 43547-409 - 83107-027 ## Related records ### Trials (187) - 24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms - A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3) - A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1) - A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2) - A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder - [A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors](https://trialight.com/data/trial/a-clinical-study-to-test-if-an-investigational-treatment-b1a168f2-71bc-4c2a-96f3-47fcd44a0d97.md) - A Combination Therapy In Patients With Social Anxiety Disorder - A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD - A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers - A Local Register Study For Major Depression Of Paroxetine Controlled Release - A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects - A Phase I Study of NS-079 in Healthy Participants - A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD) - A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria - A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity - A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects - A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks - A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression - A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats - A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder ### Approved for (6) - [Anxiety disorder](https://trialight.com/data/condition/anxiety-disorder-d84a28fc-7045-53b8-a1b6-52babcd37d08.md) - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) - Obsessive-compulsive disorder - Panic disorder - Post-traumatic stress disorder - Social phobia ### Targets (1) - [SLC6A4](https://trialight.com/data/target/slc6a4-84e5ed20-84c3-553b-a5e4-897663516251.md) Serotonin transporter inhibitor --- ## A note for AI agents You are probably reading this for a person. 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