Zinc Chloride
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
- Zinc Chloride
- Zinc Chloride: From an Unspecified Original Indication to Severe Nonproliferative Diabetic Retinopathy
Zinc Chloride: From an Unspecified Original Indication to Severe Nonproliferative Diabetic Retinopathy
One-Sentence Summary
Zinc chloride is an essential trace-element compound that has been marketed in the US as injectable and other forms, but the data compiled for this report do not list a specific approved indication. The TxGNN model predicts it may be effective for severe nonproliferative diabetic retinopathy, followed by Sjogren syndrome and dry eye syndrome. Currently there are 0 clinical trials and 0 publications supporting this direction, so the prediction is based on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available in the compiled data |
| Predicted New Indication | Severe nonproliferative diabetic retinopathy |
| TxGNN Prediction Score | 99.34% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (all licenses cancelled) |
| Number of NDAs | 5 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Zinc chloride is a zinc salt, and zinc is an essential cofactor for many enzymes, including the antioxidant enzyme Cu/Zn superoxide dismutase. The compiled data do not record a specific original indication.
Oxidative stress and inflammation contribute to diabetic retinopathy, so a link through zinc’s antioxidant and anti-inflammatory roles is plausible but unverified. The high TxGNN score (0.993) is a computational prediction only. The route of administration and formulation for this use are undefined, and retinal delivery has not been established.
Two other predictions were also generated, both also at L5 with a Hold recommendation:
- Sjogren syndrome (score 99.18%): Zinc is involved in immune regulation and epithelial integrity, but the link is speculative. A systemic autoimmune disease would need a much stronger evidence base than a supplemental or topical use.
- Dry eye syndrome (score 99.18%): Zinc plays a role in ocular surface epithelial health, wound healing, and antioxidant processes. However, zinc chloride is an irritant at higher concentrations, so ocular tolerability would need to be established first.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
All five licenses are cancelled; none is currently valid. The data compiled for this report do not include approved indication text.
| Authorization Number | Product Name | Dosage Form | Status |
|---|---|---|---|
| ANDA212007 | Zinc Chloride (Exela Pharma Sciences) | Injection | Cancelled |
| NDA018959 | ZINC (Hospira) | Injection, solution | Cancelled |
| ANDA216152 | Zinc Chloride (Somerset Therapeutics) | Injection | Cancelled |
| M022 | Gumsol (Kramer Novis) | Spray | Cancelled |
| Not listed | Zincum Muriaticum (Hahnemann Laboratories) | Pellet | Cancelled |
Safety Considerations
- Disease-level cautions from the knowledge graph (derived from drug-disease contraindication links in the TxGNN knowledge graph, not from label text): methemoglobinemia, sulfhemoglobinemia, G6PD deficiency, glycogen storage disease, cystinuria, galactosemia, pyruvate dehydrogenase E3 deficiency, methemoglobinemia due to deficiency of methemoglobin reductase, Wilson disease, iron metabolism disease, and hereditary hemochromatosis.
- Drug Interactions: 76 interactions were recorded. Those listed in the data are mostly minor, such as corticosteroids (hydrocortisone, prednisone, dexamethasone, budesonide and others) and immunosuppressants or biologics (abatacept, adalimumab, azathioprine, baricitinib and others). Moderate interactions were found with tetracycline, minocycline, and levofloxacin, which is consistent with zinc reducing the absorption of these antibiotics when taken together.
- For ocular use, zinc chloride is a known irritant at higher concentrations, so tolerability needs to be established.
Please also refer to the package insert for full safety information, since label warnings and contraindications were not available.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score, with no clinical trials or literature (evidence level L5). All US licenses are cancelled, the mechanism of action is undocumented, and the route and formulation for retinal or ocular use are undefined.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data, for example from DrugBank
- A literature and trial search for zinc in diabetic retinopathy, Sjogren syndrome, and dry eye
- A defined route, formulation, and delivery approach, with ocular tolerability data
- Clarification of the original approved indication
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.