Dactinomycin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Dactinomycin: From Cytotoxic Chemotherapy to Relapsing-Remitting Multiple Sclerosis
One-Sentence Summary
Dactinomycin is a cytotoxic DNA-binding chemotherapy agent, marketed in the US as generic lyophilized injection. The TxGNN model predicts it may be effective for relapsing-remitting multiple sclerosis, but 0 clinical trials and 0 publications were found for this pairing, so the prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Relapsing-remitting multiple sclerosis |
| TxGNN Prediction Score | 99.58% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of Licenses | 5 (all ANDAs; ANDA203385 appears twice) |
| Recommended Decision | Hold |
The supplied US label records contain no approved-indication text, so the original indication is not listed here.
Why is This Prediction Reasonable?
Dactinomycin intercalates into DNA and inhibits DNA-dependent RNA synthesis, which makes it broadly cytotoxic. No MS-specific mechanism was supplied.
The link between the original use (cancer chemotherapy) and MS is weak. MS is a chronic, non-malignant immune-mediated disease. The only conceivable rationale is a general immunosuppressive or anti-proliferative effect on activated immune cells, and that is a hypothesis, not something the supplied data support. Any such benefit would also have to be weighed against the marked toxicity of a cytotoxic agent in a chronic disease. The high score (0.996) reflects the model’s network-based inference only and should not be read as clinical support.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA203385 | Dactinomycin | Lyophilized powder for injection | Eugia US LLC |
| ANDA203999 | Dactinomycin | Lyophilized powder for injection | XGen Pharmaceuticals DJB, Inc. |
| ANDA207232 | Dactinomycin | Lyophilized powder for injection | Hisun Pharmaceuticals USA, Inc. |
| ANDA213463 | Dactinomycin | Lyophilized powder for injection | Meitheal Pharmaceuticals Inc. |
All products are injectable only. No oral or other route is available, and route compatibility for MS has not been assessed.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (DNA intercalator; antitumour antibiotic) |
| Myelosuppression Risk | Please refer to the package insert warnings and precautions |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | CBC with differential, liver function (hepatopathy and veno-occlusive disease have been reported with dactinomycin-containing regimens), renal function |
| Handling Protection | Must follow cytotoxic drug handling regulations |
Safety Considerations
- Drug Interactions: No interaction records were found for this drug in the query.
- Hepatic signal (from supplied literature in other indications): Several papers report hepatopathy and veno-occlusive disease with vincristine/dactinomycin/cyclophosphamide, with younger age as a risk factor. This is relevant to any expansion of use.
Please refer to the package insert for warnings and contraindications, which were not available in the supplied data.
Conclusion and Next Steps
Decision: Hold
Rationale: The MS prediction is L5. It has no trials, no literature and no mechanistic link beyond general cytotoxicity, and the drug’s toxicity profile is a poor fit for a chronic non-malignant disease.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (currently a blocking gap for safety screening)
- A drug-specific MOA entry from DrugBank
- Preclinical or clinical evidence linking dactinomycin to MS pathophysiology, plus a risk-benefit argument against existing MS therapies
Note on other predictions in this Evidence Pack: The rhabdomyosarcoma entries are far better supported than MS. Parameningeal embryonal rhabdomyosarcoma is graded L2 (provisional, pending full-text confirmation), with a “Proceed with Guardrails” recommendation. There, dactinomycin is a backbone drug in cooperative-group VAC-based regimens, not the variable tested. Prioritising those candidates over MS is recommended.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.