Cycle Pharmaceuticals Pipeline

Metabolic
THERAPEUTIC AREA
Homocystinuria
DOSAGE FORM
Solution
PARTNERS
Partner - Meta Healthcare
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Ease of Use & Palatability
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has been completed
PRODUCT DEVELOPMENT
Feasibility Assessment has commenced
BIO-EQUIVALENCE STUDIES
Feasibility Assessment has not yet commenced
SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2025
COMMERCIALISED BY
Commercialised By - Cycle Pharma
THERAPEUTIC AREA
Hyperammonemia
DOSAGE FORM
Suspension
PARTNERS
Partner - Meta Healthcare
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Ease of Use & Palatability
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has commenced
PRODUCT DEVELOPMENT
Feasibility Assessment has not yet commenced
BIO-EQUIVALENCE STUDIES
Feasibility Assessment has not yet commenced
SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2026
COMMERCIALISED BY
Commercialised By - Cycle Pharma
THERAPEUTIC AREA
Gaucher's Disease
DOSAGE FORM
Zydis ODT
PARTNERS
Partner - Catalent
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Low dose treatment & Ease of Use
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has been completed
PRODUCT DEVELOPMENT
Feasibility Assessment has commenced
BIO-EQUIVALENCE STUDIES
Feasibility Assessment has not yet commenced
SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2027
COMMERCIALISED BY
Commercialised By - Cycle Pharma
THERAPEUTIC AREA
Fabry Disease
DOSAGE FORM
Zydis ODT
PARTNERS
Partner - Catalent
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Low dose treatment & Ease of Use
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has commenced
PRODUCT DEVELOPMENT
Feasibility Assessment has not yet commenced
BIO-EQUIVALENCE STUDIES
Not Required
SAFETY/EFFICACY STUDIES
Feasibility Assessment has not yet commenced
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2028
COMMERCIALISED BY
Commercialised By - Cycle Pharma


Neurology
THERAPEUTIC AREA
Paediatric Epilepsy
DOSAGE FORM
Soluble tablets
PARTNERS
Partner - None
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Dose adjustment & Ease of Use
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has been completed
PRODUCT DEVELOPMENT
Feasibility Assessment has been completed
BIO-EQUIVALENCE STUDIES
Feasibility Assessment has commenced
SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2024
COMMERCIALISED BY
Commercialised By - Cycle Pharma
THERAPEUTIC AREA
Huntington's Disease
DOSAGE FORM
Zydis ODT
PARTNERS
Partner - Catalent
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Dysphagia & Ease of Use
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has been completed
PRODUCT DEVELOPMENT
Feasibility Assessment has been completed
BIO-EQUIVALENCE STUDIES
Feasibility Assessment has commenced
SAFETY/EFFICACY STUDIES
Not Required
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2025
COMMERCIALISED BY
Commercialised By - Cycle Pharma
THERAPEUTIC AREA
Tardive Dyskinesia
DOSAGE FORM
Zydis ODT
PARTNERS
Partner - Catalent
Quality of Life Needs Addressed PRODUCT DIFFERENTIATION
Dysphagia & Ease of Use
Quality of Life Needs Addressed PHYSICIAN & PATIENT SUPPORT
Physician & Patient Support - Cycle Vita
FEASIBILITY ASSESMENT
Feasibility Assessment has commenced
PRODUCT DEVELOPMENT
Feasibility Assessment has not yet commenced
BIO-EQUIVALENCE STUDIES
Not Required
SAFETY/EFFICACY STUDIES
Feasibility Assessment has not yet commenced
FDA REVIEW
Feasibility Assessment has not yet commenced
ANTICIPATED FDA APPROVAL
2027
COMMERCIALISED BY
Commercialised By - Cycle Pharma

Last updated: September 2022

PRODUCTS
TECHNOLOGY PARTNERSHIPS