Prozac
(Fluoxetine)ApprovedSmall molecule
Fluoxetine is used to treat depression, anxiety, obsessive-compulsive disorder, and panic disorder by helping to balance chemicals in the brain that affect mood and emotions.[2] Prozac is currently approved and in use across 40 indications[4].[1]
Prozac is one of 705 small molecule programs targeting Depression. It is currently in Approved.
40
Indications
185
Total Trials
23
Active Trials
704
Competitors
6
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 39 indications
Competition
Competitive Landscape
317 competitors in COVID-19
#DrugCompanyPhaseTrials
1Prozac
VVitae Pharmaceuticals Inc., an Allergan affiliate
Approved
Aldactone
PfizerPreclinical
Nexavar
BayerPreclinical
Activella
Eli LillyPreclinical
Angiomax
BBaxter Healthcare Corporation
Preclinical
Tricor
JJagotec
Preclinical
Precedex
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Preclinical
Benadryl
PParkedale
Preclinical
Nitrostat
VViatris Specialty LLC
Preclinical
Low-Molecular-Weight Heparin
Daiichi SankyoPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Major Depressive Disorder15 trials
Show 12 more trials
TDCS in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemic
Unknown status·EEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez·Phase 2/3·NCT04780152·172 enrolled
The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy
Completed·—·Phase 2·NCT04272476·20 enrolled
Depression14 trials
Show 11 more trials
Adolescent8 trials
Show 5 more trials
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
Recruiting·FFirst Affiliated Hospital of Chongqing Medical University·Phase 1/2·NCT05814640·520 enrolled
Stroke8 trials
Show 5 more trials
Acupuncture for Ischemic Post-stroke Depression
Completed·—·N/A·NCT02472613·208 enrolled
"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"
Terminated·—·N/A·NCT02063425·6 enrolled
Treatment8 trials
Treatment of Childhood Social Phobia
Completed·—·Phase 3·NCT00043537·139 enrolled
Show 5 more trials
Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)
Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00006204·106 enrolled
Treatment of Hypochondriasis With CBT and/or SSRI
Completed·—·Phase 1/2·NCT00339079·195 enrolled
89 more indications
Treatment Resistant Depression5 trials
Autism5 trials
Major Depression5 trials
Ischemic stroke4 trials
Obsessive-Compulsive Disorder4 trials
Bulimia Nervosa3 trials
Bipolar Disorder3 trials
COVID-193 trials
Prevention3 trials
Postmenopausal Women2 trials
Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression
Completed·—·Phase 4·NCT01824433·189 enrolled
Antidepressants2 trials
Bipolar Depression2 trials
Borderline personality disorder2 trials
Oral2 trials
Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?
Unknown status·—·Phase 3·NCT02562053·300 enrolled
Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in Severe Premenstrual Syndrome
Unknown status·—·Phase 3·NCT02488538·300 enrolled
Enuresis2 trials
Elective2 trials
Constipation2 trials
Fluoxetine for Refractory Constipation
Completed·—·N/A·NCT06750445·316 enrolled
Pulmonary Arterial Hypertension2 trials
Single Dose1 trial
Intracerebral Hemorrhage1 trial
Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage
Terminated·—·Phase 3·NCT01737541·32 enrolled
Musculoskeletal1 trial
Post-Traumatic Stress Disorder1 trial
Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)
Completed·—·Phase 3·NCT00000379
NAC1 trial
Anorexia Nervosa1 trial
Partial Epilepsy1 trial
Severe Depression1 trial
End-Stage Renal Disease1 trial
Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
Withdrawn·—·Phase 4·NCT00573547
Cohort Study1 trial
Anxiety1 trial
MPA1 trial
Adult Subject1 trial
Mental Disorders1 trial
Menstrual Cycle1 trial
Medication1 trial
Refractory1 trial
Treatment Duration1 trial
Glioma1 trial
Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)
Active, not recruiting·—·Phase 1·NCT05634707·10 enrolled
Generalized Anxiety Disorder1 trial
Respiratory Depression1 trial
Electroacupuncture1 trial
Multiple Sclerosis1 trial
Non-Small Cell Lung Cancer1 trial
Age1 trial
Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome
Unknown status·—·Phase 3·NCT02427334·210 enrolled
Intermittent Explosive Disorder1 trial
Acute Kidney Injury1 trial
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02320240·3,255,526 enrolled
Type 1 Diabetes Mellitus1 trial
Clinical Trial1 trial
Effectiveness1 trial
Depressive Symptoms1 trial
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Completed·—·Phase 3·NCT00578669·206 enrolled
Refractory Depression1 trial
Relapsing-Remitting Multiple Sclerosis1 trial
Anxiety Disorder1 trial
Fluoxetine vs CBT in Childhood Anxiety Disorders
Active, not recruiting·—·Phase 3·NCT04760275·316 enrolled
Menopausal Women1 trial
Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Unknown status·—·N/A·NCT02188225·140 enrolled
Injury1 trial
Refractory Constipation1 trial
Colorectal Adenocarcinoma1 trial
Unspecified9 trials
Effect of Fluoxetine (Prozac) on Domestic Violence
Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00011765·104 enrolled
Show 6 more trials
Regulatory
FDA Approval Timeline[5]
Apr 24, 1991
PROZAC
NDA NDA020101
Dec 23, 1992
PROZAC
NDA NDA018936
Mar 9, 1999
PROZAC
NDA NDA020974
Feb 26, 2001
PROZAC WEEKLY
NDA NDA021235
May 19, 2006
SARAFEM
NDA NDA021860
Oct 6, 2011
FLUOXETINE HYDROCHLORIDE
NDA NDA202133
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Prozac drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Fluoxetine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details