Reteplase
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Reteplase: From Myocardial Infarction to Posterolateral Myocardial Infarction
One-Sentence Summary
Reteplase is a recombinant thrombolytic (plasminogen activator) whose established clinical role is dissolving coronary thrombi in acute myocardial infarction, though the current record has no confirmed original-indication or MOA text on file. The TxGNN model predicts it may also be effective for Posterolateral Myocardial Infarction, a specific anatomical subtype of MI, but this prediction is currently backed only by 0 clinical trials and 1 case-report-level publication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available — no market license or indication text on file |
| Predicted New Indication | Posterolateral Myocardial Infarction |
| TxGNN Prediction Score | 99.90% |
| Evidence Level | L4 |
| India Market Status | Not Marketed |
| Number of Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for Reteplase in this record. However, based on the literature evidence collected (e.g., PMID 1719279, describing “BM 06.022,” Reteplase’s developmental compound, as a recombinant plasminogen activator with coronary thrombolytic activity comparable to alteplase), Reteplase’s pharmacological class as a fibrin-selective thrombolytic is well established in the wider clinical literature, primarily through its use in acute myocardial infarction (as reflected in major trials such as GUSTO-V and SPEED referenced under related predictions).
Posterolateral myocardial infarction is not a distinct disease mechanism — it is an anatomical descriptor of MI based on the coronary territory occluded (typically the left circumflex or its branches). Since Reteplase’s therapeutic action is to lyse the occluding thrombus regardless of anatomical location, extending its use to this MI subtype is mechanistically coherent with its known thrombolytic action in MI generally. This is consistent with the pattern seen across this candidate’s other high-ranking predictions (posteroinferior MI, septal MI, coronary stenosis), which cluster around the same core thrombolytic mechanism rather than representing a novel biological pathway.
That said, the current evidence specific to the posterolateral subtype is thin — a single case report rather than a dedicated trial — so the prediction should be read as an extension of well-established general MI thrombolysis rather than as independently validated for this specific anatomical subtype.
Clinical Trial Evidence
Currently no related clinical trials registered
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21351226 | 2011 | Case report | Catheterization and Cardiovascular Interventions | Describes a 37-year-old patient with posterolateral acute MI and unprotected left-main disease treated with mini-crush drug-eluting stenting facilitated by intracoronary Reteplase during primary PCI |
India Market Information
Currently no market license/registration records available (Market Status: Not Marketed).
Safety Considerations
Drug Interactions: 137 documented interactions on file. Notable interactions include:
- Major: Deferasirox, Ibritumomab tiuxetan, Tositumomab, Tositumomab (I-131), Abciximab, Acalabrutinib, Apixaban, Avapritinib, Betrixaban — increased bleeding risk when combined with Reteplase
- Moderate: Acetylsalicylic acid, Dexfenfluramine, Fenfluramine, Sibutramine, Ketorolac (systemic and ophthalmic), Ibuprofen, Diclofenac (topical), Aminocaproic acid, Celecoxib, Omega-3 fatty acids
No confirmed key warnings or contraindications are currently on file — please refer to the official package insert for these details once available.
Conclusion and Next Steps
Decision: Hold
Rationale: Key safety data (warnings and contraindications) is a Blocking data gap that prevents a proper S1 safety review, and the drug currently has no market registration in this jurisdiction. While the thrombolytic mechanism plausibly extends to this MI subtype, direct evidence for the specific “posterolateral MI” indication is limited to a single case report with no supporting trials.
To proceed, the following is needed:
- Official label/safety data (warnings, contraindications) — currently the blocking gap (DG001)
- Confirmed mechanism of action documentation (DG002)
- Market registration status and licensing pathway for this jurisdiction
- Additional clinical evidence (observational studies or trials) specific to posterolateral MI, beyond the existing single case report
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.