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Sertraline Pill
Sertraline Pill is a SSRI Small molecule drug developed by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). It is currently in Phase 3 development for Major depressive disorder, Obsessive-compulsive disorder, Panic disorder. Also known as: Antidepressants-Sertraline, Zoloft.
Sertraline is a selective serotonin reuptake inhibitor (SSRI) that increases the levels of serotonin in the brain.
Sertraline is a small molecule medication used to treat various conditions, including depression, posttraumatic stress disorder, obsessive-compulsive disorder, and others, as indicated by ClinicalTrials.gov. It is available in pill form and is used in clinical trials to compare its effectiveness against a placebo.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sertraline Pill |
|---|---|
| Also known as | Antidepressants-Sertraline, Zoloft |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
| Drug class | SSRI |
| Target | Serotonin transporter |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
By blocking the reabsorption of serotonin, sertraline allows more serotonin to be available in the brain, which can help improve mood and reduce symptoms of depression and anxiety.
Approved indications
- Major depressive disorder
- Obsessive-compulsive disorder
- Panic disorder
- Post-traumatic stress disorder
- Premenstrual dysphoric disorder
Common side effects
- Nausea
- Headache
- Dizziness
- Fatigue
- Insomnia
Key clinical trials
- Predicting SSRI Efficacy in Veterans With PTSD (PHASE4)
- The Friendship Bench Plus Trial (NA)
- Treatment of Orthostatic Intolerance (PHASE1, PHASE2)
- Efficacy of Statins Among Major Depressive Disorder (PHASE3)
- Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD (PHASE3)
- Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder (PHASE4)
- Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder (PHASE3)
- Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities. (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sertraline Pill CI brief — competitive landscape report
- Sertraline Pill updates RSS · CI watch RSS
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) portfolio CI
Frequently asked questions about Sertraline Pill
What is Sertraline Pill?
How does Sertraline Pill work?
What is Sertraline Pill used for?
Who makes Sertraline Pill?
Is Sertraline Pill also known as anything else?
What drug class is Sertraline Pill in?
What development phase is Sertraline Pill in?
What are the side effects of Sertraline Pill?
What does Sertraline Pill target?
Related
- Drug class: All SSRI drugs
- Target: All drugs targeting Serotonin transporter
- Manufacturer: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Obsessive-compulsive disorder
- Indication: Drugs for Panic disorder
- Also known as: Antidepressants-Sertraline, Zoloft
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing