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Scenesse

(Afamelanotide)

ApprovedPeptide

CClinuvel Pharmaceuticals Limited

Afamelanotide is used to help protect the skin of people with a rare condition called erythropoietic protoporphyria (EPP), which causes severe pain and burning when their skin is exposed to sunlight.[2] Scenesse is currently approved and in use across 10 indications[4].[1]

Scenesse is one of 173 small molecule programs targeting Stroke. It is currently in Approved.

10

Indications

22

Total Trials

0

Active Trials

172

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

StrokeActive, not recruiting

AcneApproved

Variegate PorphyriaActive, not recruiting

UrticariaActive, not recruiting

Cutaneous PorphyriaActive, not recruiting

Erythropoietic ProtoporphyriaActive, not recruiting

Xeroderma PigmentosumActive, not recruiting

Polymorphic Light EruptionActive, not recruiting

VitiligoActive, not recruiting

Ischemic StrokeApproved

StrokePhase 2

Active, not recruiting

AcneApproved

Approved

Variegate PorphyriaPhase 2

Active, not recruiting

UrticariaPhase 2

Active, not recruiting

Cutaneous PorphyriaApproved

Active, not recruiting

Erythropoietic ProtoporphyriaPhase 3

Active, not recruiting

Xeroderma PigmentosumPhase 2

Active, not recruiting

Polymorphic Light EruptionPhase 3

Active, not recruiting

VitiligoPhase 2

Active, not recruiting

Ischemic StrokeApproved

Approved

Competition

Competitive Landscape

461 competitors in Stroke

#DrugCompanyPhaseTrials

Scenesse

CClinuvel Pharmaceuticals Limited

Activase

Savella

Botox

RRevance Therapeutics, Inc.

Zantac 150

Direct Anticoagulant

Anticoagulants

Inderal

Mylan Pharmaceuticals Inc

Atorvastatin Calcium

Biological Check-up

UUniversity Hospital, Bordeaux

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Erythropoietic Protoporphyria6 trials

Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)

Completed·CClinuvel Pharmaceuticals Limited·Phase 3·NCT00979745·74 enrolled

A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

Completed·CClinuvel Pharmaceuticals Limited·Phase 3·NCT04578496·16 enrolled

Multicentre Phase III Erythropoietic Protoporphyria Study

Completed·CClinuvel Pharmaceuticals Limited·Phase 3·NCT04053270·100 enrolled

Show 3 more trials

Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

Completed·CClinuvel Europe Limited·Phase 1/2·NCT06388642·28 enrolled

Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT01097044·77 enrolled

Phase III Confirmatory Study in Erythropoietic Protoporphyria

Completed·CClinuvel Pharmaceuticals Limited·Phase 3·NCT01605136·93 enrolled

Vitiligo4 trials

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT04525157·21 enrolled

A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face

Unknown status·CClinuvel, Inc.·Phase 2·NCT05210582·6 enrolled

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT01382589·15 enrolled

Show 1 more trial

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

Completed·CClinuvel Pharmaceuticals Limited·Phase 1·NCT01430195·56 enrolled

Polymorphic Light Eruption2 trials

Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

Completed·CClinuvel Pharmaceuticals Limited··NCT00472901·18 enrolled

Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Completed·CClinuvel Pharmaceuticals Limited·Phase 3·NCT04704713·31 enrolled

Xeroderma Pigmentosum2 trials

A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)

Unknown status·CClinuvel Europe Limited·Phase 2·NCT05159752·6 enrolled

A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

Unknown status·CClinuvel Europe Limited·Phase 2·NCT05370235·6 enrolled

Urticaria1 trial

Phase II Solar Urticaria (SU) Pilot Study

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT00859534·5 enrolled

6 more indications

Variegate Porphyria1 trial

Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT05854784·6 enrolled

Phase II1 trial

Phase II AK Study in Organ Transplant Patients

Unknown status·CClinuvel Pharmaceuticals Limited·Phase 2·NCT00829192·200 enrolled

Stroke1 trial

A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT04962503·6 enrolled

Age1 trial

DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers

Completed·CClinuvel (UK) Ltd.·Phase 1·NCT05368857·10 enrolled

Acne Vulgaris1 trial

Afamelanotide in Patients Suffering With Acne Vulgaris

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT04943159·3 enrolled

Unspecified2 trials

Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

Completed·CClinuvel Pharmaceuticals Limited·Phase 2·NCT04425746·16 enrolled

Implant Pharmacokinetic and Pharmacodynamic Study

Completed·CClinuvel Pharmaceuticals Limited·Phase 1·NCT03634137·24 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 8, 2019

SCENESSE

NDA NDA210797

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Afamelanotide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Scenesse drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Afamelanotide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Afamelanotide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210797). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Scenesse. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Clinuvel Pharmaceuticals Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Melanocortin Receptor 1 Agonist[3]
Modality: Peptide[3]
Highest Phase: Approved[1]
Company: CClinuvel Pharmaceuticals Limited

Patent Landscape[6]

Patent Cliff

Jan 20, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8334265Jan 20, 2033

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