Evogliptin

Evidence Level: L5 Predicted Indications: 5

Table of Contents

  1. Evogliptin
    1. Pharmacist Assessment Report
    2. Evogliptin: From Type 2 Diabetes Mellitus to Opsismodysplasia
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. India Market Information
    7. Conclusion and Next Steps
    8. Review Log
    9. Disclaimer

Pharmacist Assessment Report

Evogliptin: From Type 2 Diabetes Mellitus to Opsismodysplasia

One-Sentence Summary

Evogliptin is a DPP-4 inhibitor originally used to treat type 2 diabetes mellitus. The TxGNN model predicts it may be effective for Opsismodysplasia, a rare skeletal dysplasia. However, there are currently 0 clinical trials and 0 publications supporting this prediction, so it rests on model output alone.

Quick Overview

Item Content
Original Indication Type 2 diabetes mellitus
Predicted New Indication Opsismodysplasia
TxGNN Prediction Score 0.9935
Evidence Level L5
India Market Status Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data
Number of Listed Products 3 (valid: 3)
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, evogliptin belongs to the DPP-4 inhibitor class. These drugs slow the breakdown of incretin hormones, which helps control blood sugar in type 2 diabetes.

Opsismodysplasia is a rare skeletal disorder caused by loss-of-function mutations in INPPL1 (SHIP2). These mutations affect PI3K/AKT signaling and bone formation (endochondral ossification). No established link connects DPP-4 inhibition to SHIP2 or to skeletal development pathways, so the mechanistic basis for this prediction is weak.

The very high TxGNN score (0.9935) should be read as a model-derived association only. No trials, literature, or preclinical data back it up. Other top-ranked predictions (thiamine-responsive dysfunction syndrome, focal stiff limb syndrome, classic stiff person syndrome, drug-induced localized lipodystrophy) share the same limitation. The stiff-person spectrum conditions have a speculative immune-modulation rationale through DPP-4/CD26 on T cells, but this is hypothesis-level only.

India Market Information

Authorization Number Product Name Dosage Form Approved Indication
233532 Valera M 1000 Tablet SR Strip of 15 sustained-release tablets Not specified
233304 Valera Tablet Strip of 15 tablets Not specified
233332 Valera M 500 Tablet SR Strip of 15 sustained-release tablets Not specified

All three authorizations are valid registrations held by Alkem Laboratories Ltd, in oral form.

Review correction (2026-11-06): Originally stated: “All three authorizations are valid single-ingredient registrations held by Alkem Laboratories Ltd, in oral form.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by the TxGNN model score, with no clinical trials or publications and no plausible mechanistic link between DPP-4 inhibition and opsismodysplasia. Evidence level is L5.

To proceed, the following is needed:

  • Detailed mechanism of action data (MOA) for evogliptin
  • Package insert safety information (warnings and contraindications) from the India regulatory source
  • Preclinical or mechanistic studies exploring any connection between DPP-4 and INPPL1/SHIP2 or PI3K/AKT signaling in skeletal development
  • Reassessment of other predicted indications, which have the same evidence gap

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date Item Action Source
2026-11-06 Removed: “single-ingredient” Corrected Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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