Active Ingredient History
Fluoxetine hydrochloride is the first agent of the class of antidepressants known as selective serotonin-reuptake inhibitors (SSRIs). Fluoxetine is a racemic mixture of the R- and S- enantiomers and are of equivalent pharmacologic activity. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Fluoxetine is marketed under the trade names Prozac and Sarafem among others. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). PROZAC is a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years • Acute and maintenance treatment of Bulimia Nervosa in adult patients • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine. Antagonism of muscarinic, histaminergic, and α1-adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs. Fluoxetine binds to these and other membrane receptors from brain tissue much less potently in vitro than do the tricyclic drugs. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
Combination drugs
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Bulimia Nervosa (approved 1987)
Obsessive-Compulsive Disorder (approved 1987)
Panic Disorder (approved 1987)
Alcoholism (Phase 4)
Alcohol-Related Disorders (Phase 4)
Anorexia Nervosa (Phase 4)
Antidepressive Agents (Phase 4)
Anxiety (Phase 3)
Anxiety Disorders (Phase 4)
Anxiety, Separation (Phase 3)
Autistic Disorder (Phase 3)
Back Pain (Phase 2)
Bipolar Disorder (Phase 4)
Body Dysmorphic Disorders (Phase 4)
Borderline Personality Disorder (Phase 4)
Brain Diseases (Phase 2)
Brain Infarction (Phase 2)
Brain Ischemia (Phase 2)
Brain Neoplasms (Early Phase 1)
Central Nervous System Diseases (Phase 2)
Cerebral Hemorrhage (Phase 3)
Cerebral Infarction (Phase 2)
Cerebrovascular Disorders (Phase 2)
Cocaine-Related Disorders (Phase 2)
COVID-19 (Phase 4)
Cytokine Release Syndrome (Phase 4)
Dementia (Phase 3)
Depression (Phase 4)
Depressive Disorder, Major (Phase 4)
Depressive Disorder, Treatment-Resistant (Phase 3)
Diabetes Mellitus, Type 1 (Early Phase 1)
DiGeorge Syndrome (Phase 4)
Domestic Violence (Phase 2)
Down Syndrome (Phase 4)
Dysthymic Disorder (Phase 4)
Epilepsy (Phase 3)
Fatigue (Phase 2)
Feeding and Eating Disorders (Phase 4)
Fibromyalgia (Phase 4)
Fluoxetine (Phase 4)
Fragile X Syndrome (Phase 4)
Gastroesophageal Reflux (Phase 2/Phase 3)
Growth Hormone (Phase 2)
Healthy Volunteers (Phase 4)
Heart Diseases (Phase 1/Phase 2)
Hemodialysis, Home (Phase 4)
HIV Infections (Phase 2)
Hypochondriasis (Phase 1/Phase 2)
Hypoglycemia (Early Phase 1)
Hypoxia (Phase 3)
Influenza, Human (Phase 4)
Influenza Vaccines (Phase 4)
Ischemic Stroke (Phase 2)
Kidney Failure, Chronic (Phase 4)
Lung Neoplasms (Phase 2)
Marijuana Abuse (Phase 4)
Menopause (Phase 4)
Mental Disorders (Phase 4)
Mental Health (Phase 4)
Mood Disorders (Phase 4)
Motor Activity (Phase 3)
Multiple Sclerosis, Chronic Progressive (Phase 2)
Multiple Sclerosis, Relapsing-Remitting (Phase 4)
Multiple System Atrophy (Phase 2)
Musculoskeletal Diseases (Early Phase 1)
Mutism (Phase 2)
Nervous System Diseases (Phase 2)
Nocturnal Enuresis (Phase 3)
Obesity (Phase 2)
Obsessive Behavior (Phase 4)
Obsessive-Compulsive Disorder (Phase 4)
Personality Disorders (Phase 3)
Pharmacogenetics (Phase 4)
Phobia, Social (Phase 3)
Postmenopause (Phase 2)
Premenstrual Dysphoric Disorder (Phase 4)
Premenstrual Syndrome (Phase 4)
Prostatic Hyperplasia (Phase 3)
Prostatic Neoplasms (Phase 2/Phase 3)
Psychophysiologic Disorders (Phase 3)
Psychotic Disorders (Phase 3)
Pulmonary Arterial Hypertension (Phase 2)
Risk Factors (Phase 3)
Schizophrenia (Phase 4)
Sciatica (Phase 2)
Signs and Symptoms (Phase 2)
Smoking (Phase 3)
Stress Disorders, Post-Traumatic (Phase 4)
Stroke (Phase 4)
Substance-Related Disorders (Phase 4)
Sudden Unexpected Death in Epilepsy (Phase 2)
Suicide (Phase 4)
Suicide, Attempted (Phase 2/Phase 3)
Tobacco Use Disorder (Phase 3)
Vascular Diseases (Phase 2)
Venlafaxine Hydrochloride (Phase 4)
Visual Fields (Phase 2)
Williams Syndrome (Phase 4)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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