Cycle Pharmaceuticals Pipeline
Metabolic
Neurology
THERAPEUTIC AREA
Homocystinuria
DOSAGE FORM
Solution
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Ease of Use & Palatability
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES

SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW

ANTICIPATED FDA APPROVAL
2025
COMMERCIALISED BY

THERAPEUTIC AREA
Hyperammonemia
DOSAGE FORM
Suspension
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Ease of Use & Palatability
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES

SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW

ANTICIPATED FDA APPROVAL
2026
COMMERCIALISED BY

THERAPEUTIC AREA
Gaucher's Disease
DOSAGE FORM
Zydis ODT
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Low dose treatment & Ease of Use
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES

SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW

ANTICIPATED FDA APPROVAL
2027
COMMERCIALISED BY

THERAPEUTIC AREA
Fabry Disease
DOSAGE FORM
Zydis ODT
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Low dose treatment & Ease of Use
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES
Not Required
SAFETY/EFFICACY STUDIES

FDA REVIEW

ANTICIPATED FDA APPROVAL
2028
COMMERCIALISED BY

Neurology
THERAPEUTIC AREA
Paediatric Epilepsy
DOSAGE FORM
Soluble tablets
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Dose adjustment & Ease of Use
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES

SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW

ANTICIPATED FDA APPROVAL
2024
COMMERCIALISED BY

THERAPEUTIC AREA
Huntington's Disease
DOSAGE FORM
Zydis ODT
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Dysphagia & Ease of Use
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES

SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW

ANTICIPATED FDA APPROVAL
2025
COMMERCIALISED BY

THERAPEUTIC AREA
Tardive Dyskinesia
DOSAGE FORM
Zydis ODT
PARTNERS

Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
Dysphagia & Ease of Use
Quality of Life Needs Addressed
PHYSICIAN & PATIENT SUPPORT

FEASIBILITY ASSESMENT

PRODUCT DEVELOPMENT

BIO-EQUIVALENCE STUDIES
Not Required
SAFETY/EFFICACY STUDIES

FDA REVIEW

ANTICIPATED FDA APPROVAL
2027
COMMERCIALISED BY

Last updated: September 2022