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Aventyl (NORTRIPTYLINE HYDROCHLORIDE)
Aventyl (generic name: NORTRIPTYLINE HYDROCHLORIDE) is a Tricyclic Antidepressant Small molecule drug developed by Specgx Llc. It is currently FDA-approved (first approved 1964) for Depressive disorder.
Aventyl, also known as nortriptyline, is a medication used in the medical management of conditions such as Painful Diabetic Neuropathy and Peripheral Neuropathy With Type 2 Diabetes. It is being studied in a randomized-controlled trial, NCT07509671, to evaluate its effectiveness in treating Painful Diabetic Neuropathy with diet.
At a glance
| Generic name | NORTRIPTYLINE HYDROCHLORIDE |
|---|---|
| Sponsor | Specgx Llc |
| Drug class | Tricyclic Antidepressant |
| Target | Sodium-dependent noradrenaline transporter |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1964 |
Approved indications
- Depressive disorder
Boxed warnings
- Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nortriptyline hydrochloride capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride capsules are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use).
Common side effects
- Temperature regulation disorder
- Completed suicide
- Toxicity to various agents
- Food allergy
- Coeliac disease
- Immunodeficiency
- Pneumonia aspiration
- Bursitis
- Hyperhidrosis
- Coma
- Drug hypersensitivity
- Gastrooesophageal reflux disease
Drug interactions
- pargyline
- paroxetine
- phenelzine
- pimozide
- procarbazine
- quinidine
- rifabutin
- rifampicin
- rifapentine
- ritonavir
- selegiline
- sertraline
Key clinical trials
- Procedural Framing and Epidural Steroid Injection Outcomes (NA)
- Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (PHASE2)
- An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service (PHASE3)
- Management of Acute Tinnitus With Migraine Medications (PHASE4)
- Pediatric Concussion Outcomes (PHASE4)
- Nortriptyline for the Treatment of Functional Dyspepsia (PHASE3)
- RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT) (PHASE4)
- Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Aventyl CI brief — competitive landscape report
- Aventyl updates RSS · CI watch RSS
Frequently asked questions about Aventyl
What is Aventyl?
Aventyl (NORTRIPTYLINE HYDROCHLORIDE) is a Tricyclic Antidepressant drug developed by Specgx Llc, indicated for Depressive disorder.
What is Aventyl used for?
Aventyl is indicated for Depressive disorder.
Who makes Aventyl?
Aventyl is developed and marketed by Specgx Llc.
What is the generic name of Aventyl?
NORTRIPTYLINE HYDROCHLORIDE is the generic (nonproprietary) name of Aventyl.
What drug class is Aventyl in?
Aventyl belongs to the Tricyclic Antidepressant class. See all Tricyclic Antidepressant drugs at /class/tricyclic-antidepressant.
When was Aventyl approved?
Aventyl was first approved on 1964.
What development phase is Aventyl in?
Aventyl is FDA-approved (marketed).
What are the side effects of Aventyl?
Common side effects of Aventyl include Temperature regulation disorder, Completed suicide, Toxicity to various agents, Food allergy, Coeliac disease, Immunodeficiency.
What does Aventyl target?
Aventyl targets Sodium-dependent noradrenaline transporter and is a Tricyclic Antidepressant.
Related
- Drug class: All Tricyclic Antidepressant drugs
- Target: All drugs targeting Sodium-dependent noradrenaline transporter
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Depressive disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing