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Clinuvel Pharmaceuticals (CUV) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| Afamelanotide | Acne Vulgaris | Phase II | Completed | Afamelanotide in Patients Suffering With Acne Vulgaris | Jun 21, 2021 | ― |
| Afamelanotide | Polymorphic Light Eruption | Phase III | Completed | Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) | Jan 08, 2021 | ― |
| Afamelanotide | Erythropoietic Protoporphyria | Phase III | Completed | A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | Oct 05, 2020 | ― |
| Afamelanotide | Vitiligo | Phase II | Completed | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) | Aug 06, 2020 | ― |
| 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 | ― |
| Afamelanotide | Erythropoietic Protoporphyria | Phase III | Completed | Multicentre Phase III Erythropoietic Protoporphyria Study | Aug 08, 2019 | ― |
| Afamelanotide | Erythropoietic Protoporphyria | Phase III | Completed | Phase III Confirmatory Study in Erythropoietic Protoporphyria | May 22, 2012 | ― |
| Afamelanotide | Erythropoietic Protoporphyria | Phase II | Completed | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) | Mar 30, 2010 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Afamelanotide 16 Mg | Phase II | Variegate Porphyria | Completed | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) | May 03, 2023 | ― |
| Afamelanotide | Phase II | Arterial Ischemic Stroke | Completed | A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) | Jun 23, 2021 | ― |
| Afamelanotide | Phase II | Acne Vulgaris | Completed | Afamelanotide in Patients Suffering With Acne Vulgaris | Jun 21, 2021 | ― |
| Afamelanotide | Phase III | Polymorphic Light Eruption | Completed | Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) | Jan 08, 2021 | ― |
| Afamelanotide | Phase III | Erythropoietic Protoporphyria | Completed | A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | Oct 05, 2020 | ― |
| Afamelanotide | Phase II | Vitiligo | Completed | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) | Aug 06, 2020 | ― |
| Afamelanotide | Phase II | Patients Undergoing Photodynamic Therapy Using Porfimer Sodium | Completed | Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium | Jun 08, 2020 | ― |
| Afamelanotide | Phase III | Erythropoietic Protoporphyria | Completed | Multicentre Phase III Erythropoietic Protoporphyria Study | Aug 08, 2019 | ― |
| Afamelanotide | Phase III | Erythropoietic Protoporphyria | Completed | Phase III Confirmatory Study in Erythropoietic Protoporphyria | May 22, 2012 | ― |
| Afamelanotide | Phase II | Erythropoietic Protoporphyria | Completed | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) | Mar 30, 2010 | ― |
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
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 (AU:CUV) have in its pipeline
Clinuvel Pharmaceuticals AU:CUV is currently developing the following drugs: Afamelanotide 16 Mg, Afamelanotide, Afamelanotide Group 1, Afamelanotide Group 2. These drug candidates are in various stages of clinical development as the company works toward FDA approval.