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Clinuvel Pharmaceuticals Limited (AU:CUV)
ASX:CUV
Afamelanotide 16 Mg
Variegate Porphyria
Phase II
Completed
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
May 03, 2023
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Afamelanotide
Arterial Ischemic Stroke
Phase II
Completed
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Jun 23, 2021
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Afamelanotide
Acne Vulgaris
Phase II
Completed
Afamelanotide in Patients Suffering With Acne Vulgaris
Jun 21, 2021
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Afamelanotide
Polymorphic Light Eruption
Phase III
Completed
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
Jan 08, 2021
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Afamelanotide
Erythropoietic Protoporphyria
Phase III
Completed
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
Oct 05, 2020
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Afamelanotide
Vitiligo
Phase II
Completed
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
Aug 06, 2020
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Afamelanotide
Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Phase II
Completed
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
Jun 08, 2020
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Afamelanotide
Erythropoietic Protoporphyria
Phase III
Completed
Multicentre Phase III Erythropoietic Protoporphyria Study
Aug 08, 2019
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Afamelanotide
Erythropoietic Protoporphyria
Phase III
Completed
Phase III Confirmatory Study in Erythropoietic Protoporphyria
May 22, 2012
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Afamelanotide
Erythropoietic Protoporphyria
Phase II
Completed
Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)
Mar 30, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Clinuvel Pharmaceuticals Limited (CUV) have in its pipeline
CUV is currently developing the following drugs: Afamelanotide 16 Mg, Afamelanotide, Afamelanotide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.