Desipramine
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
Desipramine: From Tricyclic Antidepressant to ADHD, Inattentive Type
One-Sentence Summary
Desipramine is a tricyclic antidepressant that is currently marketed in the United States as several generic oral products. The TxGNN model predicts it may be effective for Attention Deficit Hyperactivity Disorder, Inattentive Type. For this subtype, 0 clinical trials and 0 publications were retrieved, so the prediction is supported by the model score only.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Attention deficit hyperactivity disorder, inattentive type |
| TxGNN Prediction Score | 99.81% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
The supplied data lists no approved indication text, so the original indication is not shown here.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Desipramine is known to be a norepinephrine reuptake inhibitor. In ADHD, this pathway is also targeted by atomoxetine, and it is plausibly relevant to the subtype predicted here.
No trials or literature were retrieved specifically for the inattentive subtype. The subtype is best evaluated under the parent entry, attention deficit-hyperactivity disorder (TxGNN score 99.78%). That entry has 14 retrieved publications, including systematic reviews such as a Cochrane review of tricyclic antidepressants in children and adolescents (PMID 25238582). Trial-level phase and desipramine-specific effect sizes were not verified from the supplied data, so that entry is only tentatively rated L2 and labelled a research question.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for this specific subtype.
US Market Information
The 20 authorizations are all oral generic (ANDA) products. The supplied data has no approved-indication text for any of them. The main unique authorizations are listed below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA208105 | Desipramine Hydrochloride | Tablet, film coated | Amneal Pharmaceuticals NY LLC |
| ANDA207433 | Desipramine Hydrochloride | Tablet | Chartwell RX, LLC |
| ANDA204963 | Desipramine Hydrochloride | Tablet | Ingenus Pharmaceuticals, LLC |
| ANDA074430 | Desipramine Hydrochloride | Tablet, film coated | Actavis Pharma, Inc. |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is model-only (L5), with no trials or literature for the inattentive subtype. The stronger evidence sits under the parent ADHD entry. That entry also carries cardiovascular safety concerns in paediatric use and tricyclic overdose risk, which limit it to a research question at most.
To proceed, the following is needed:
- Re-evaluate under the parent ADHD indication, and verify phase and desipramine-specific effect sizes in the retrieved systematic reviews (for example the Cochrane review, PMID 25238582).
- Obtain the FDA package insert warnings and contraindications, which are currently a blocking data gap.
- Obtain the mechanism of action data from DrugBank.
- Assess paediatric cardiovascular safety and overdose risk before any clinical direction is considered.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.