Cycle Pharmaceuticals Pipeline
Metabolic
| Indication | Technology | Partners | Quality of life needs addressed | Feasibility | Development | Bio-Equivalence Studies |
Safety/Efficacy Studies |
FDA Review |
FDA Approval |
Commercialised by |
||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technical Improvments | Specialized Services for patients | |||||||||||
| NITYR® Hereditary Tyrosinemia Type 1(HT-1) | Oral Tablet |  |
Ease of use Stability Reduced Size |  |
2017 |  |
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| Gaucher’s Disease | Capsules |  |
|
Not Required | 2021 | |
||||||
| Phenylketonuria (PKU) | Oral Tablet & Powder for Solution |  |
|
Not Required | 2022 | |
||||||
| Gaucher’s Disease | Zydis® ODT |  |
Low dose treatment Ease of Use | |
Not Required | 2024 | |
|||||
| Fabry Disease | Zydis® ODT | |
Low dose treatment Ease of Use | |
Not Required | 2026 | |
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Neurology
| Indication | Technology | Partners | Quality of life needs addressed | Feasibility | Development | Bio-Equivalence Studies |
Safety/Efficacy Studies |
FDA Review |
FDA Approval |
Commercialised by |
||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technical Improvments | Specialized Services for patients | |||||||||||
| Wilson's Disease | Capsules | |
|
Not Required | 2021 | |
||||||
| Paediatric epilepsy | Soluble Tablets |  |
Dose adjustment Ease of Use | |
Not Required | 2022 | |
|||||
| Huntington’s Disease | Zydis® ODT | |
Dysphagia Ease of Use | |
Not Required | 2023 | |
|||||
| Parkinson’s Disease | Zydis® ODT | |
Dysphagia Ease of Use | |
Not Required | 2024 | |
|||||
| Tardive Dyskinesia | Zydis® ODT | |
Dysphagia Ease of Use | |
Not Required | 2025 | |
|||||
| Huntington’s Disease | TEPI® Transdermal Patch |  |
Avoids dysphagia Reduction of Side Effects | |
Not Required | 2025 | |
|||||
Immunology
| Indication | Technology | Partners | Quality of life needs addressed | Feasibility | Development | Bio-Equivalence Studies |
Safety/Efficacy Studies |
FDA Review |
FDA Approval |
Commercialised by |
||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technical Improvments | Specialized Services for patients | |||||||||||
| Hereditary Angioedema | Pre-filled syringe |  |
|
Not Required | 2021 | |
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Last updated: June 2021
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