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
THERAPEUTIC AREA
DOSAGE FORM
PARTNERS
Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
PHYSICIAN & PATIENT SUPPORT
FEASIBILITY ASSESMENT
PRODUCT DEVELOPMENT
BIO-EQUIVALENCE STUDIES
SAFETY/EFFICACY STUDIES
FDA REVIEW
ANTICIPATED FDA APPROVAL
COMMERCIALISED BY
Homocystinuria
Solution
Partner - Meta Healthcare
Ease of Use & Palatability
Physician & Patient Support - Cycle Vita
Feasibility Assessment has been completed
Product Development has commenced
Bio-Equivalence Studies has not yet commenced
Not Required
FDA Review has not yet commenced
2025
Commercialised By - Cycle Pharma
Hyperammonemia
Suspension
Partner - Meta Healthcare
Ease of Use & Palatability
Physician & Patient Support - Cycle Vita
Feasibility Assessment has commenced
Product Development has not yet commenced
Bio-Equivalence Studies has not yet commenced
Not Required
FDA Review has not yet commenced
2026
Commercialised By - Cycle Pharma
Gaucher's Disease
Zydis ODT
Partner - Catalent
Low dose treatment & Ease of Use
Physician & Patient Support - Cycle Vita
Feasibility Assessment has been completed
Product Development has commenced
Bio-Equivalence Studies has not yet commenced
Not Required
FDA Review has not yet commenced
2027
Commercialised By - Cycle Pharma
Fabry Disease
Zydis ODT
Partner - Catalent
Low dose treatment & Ease of Use
Physician & Patient Support - Cycle Vita
Feasibility Assessment has commenced
Product Development has not yet commenced
Not Required
Safety / Efficacy Studies has not yet commenced
FDA Review has not yet commenced
2028
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
THERAPEUTIC AREA
DOSAGE FORM
PARTNERS
Quality of Life Needs Addressed
PRODUCT DIFFERENTIATION
PHYSICIAN & PATIENT SUPPORT
FEASIBILITY ASSESMENT
PRODUCT DEVELOPMENT
BIO-EQUIVALENCE STUDIES
SAFETY/EFFICACY STUDIES
FDA REVIEW
ANTICIPATED FDA APPROVAL
COMMERCIALISED BY
Paediatric Epilepsy
Soluble tablets
Partner - None
Dose adjustment & Ease of Use
Physician & Patient Support - Cycle Vita
Feasibility Assessment has been completed
Product Development has been completed
Bio-Equivalence Studies has commenced
Not Required
FDA Review has not yet commenced
2024
Commercialised By - Cycle Pharma
Huntington's Disease
Zydis ODT
Partner - Catalent
Dysphagia & Ease of Use
Physician & Patient Support - Cycle Vita
Feasibility Assessment has been completed
Product Development has been completed
Bio-Equivalence Studies has commenced
Not Required
FDA Review has not yet commenced
2025
Commercialised By - Cycle Pharma
Tardive Dyskinesia
Zydis ODT
Partner - Catalent
Dysphagia & Ease of Use
Physician & Patient Support - Cycle Vita
Feasibility Assessment has commenced
Product Development has not yet commenced
Not Required
Safety / Efficacy Studies has not yet commenced
FDA Review has not yet commenced
2027
Commercialised By - Cycle Pharma

Last updated: September 2022

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