Drugs / Afamelanotide
Afamelanotide
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn protoporphyria, erythropoietic, 2 7 milestones | |||||
| Filed | Other | SCENESSE® | protoporphyria, erythropoietic, 2 | 2024-10-01 | “CLINUVEL has filed a New Drug Submission (NDS) to Health Canada, seeking approval for its novel photoprotective therapy SCENESSE® (afamelanotide)” clinuvel.com ↗ “Feb ‘20 - Australian TGA validates and begins review of SCENESSE® submission” clinuvel.com ↗ |
| Withdrawn | EU (EMA) | SCENESSE® | protoporphyria, erythropoietic, 2 | 2024-06-03 | “CLINUVEL has withdrawn a submission to expand its European marketing authorisation for SCENESSE® (afamelanotide) for adolescent patients” clinuvel.com ↗ |
| Filed | EU (EMA) | SCENESSE® | protoporphyria, erythropoietic, 2 | 2022-09-05 | “submitted a formal application to the European Medicines Agency (EMA) to expand the approved indication for SCENESSE® (afamelanotide 16mg)” clinuvel.com ↗ “CLINUVEL submits SCENESSE® label expansion for adolescent EPP patients” clinuvel.com ↗ |
| Filed | Other | SCENESSE | protoporphyria, erythropoietic, 2 | 2019-12-23 | “CLINUVEL PHARMACEUTICALS LTD today announced that it has submitted an application to the Australian Therapeutic Goods Administration (TGA) for its drug SCENESSE ®” clinuvel.com ↗ “CLINUVEL’s New Drug Submission (NDS) for SCENESSE® was accepted for evaluation by Health Canada in December 2024.” clinuvel.com ↗ |
| Filed | US (FDA) | SCENESSE® | protoporphyria, erythropoietic, 2 | 2019-01-10 | “SCENESSE® (afamelanotide 16mg) in the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic p rotoporphyria (EPP) had been submitted” clinuvel.com ↗ |
| Filed | US (FDA) | SCENESSE® | protoporphyria, erythropoietic, 2 | 2018-06-25 | “CLINUVEL submitted a New Drug Application (NDA) – under Section 505(b) of Federal Food, Drug, and Cosmetic Act – for the use of SCENESSE®” clinuvel.com ↗ “completed the submission of a New Drug Application (NDA) for its drug SCENESSE® (afamelanotide 16 mg)” clinuvel.com ↗ “CLINUVEL COMPLETES SCENESSE® FDA FILING” clinuvel.com ↗ |
| Filed | EU (EMA) | SCENESSE® | protoporphyria, erythropoietic, 2 | 2012-02-06 | “CLINUVEL filed a variation to the European marketing authorisation in 2022 to expand the label of SCENESSE® to include adolescent EPP patients (aged 12-17 years).” clinuvel.com ↗ “06 Feb 2012 – EMA marketing authorisation application for SCENESSE®” clinuvel.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | US (FDA) | SCENESSE | — | 2019-10-08 | fda.gov ↗ |
| Approved | EU (EMA) | Scenesse | — | 2014-12-22 | europa.eu ↗ |
| Rejected (CRL) | US (FDA) | — | — | — | “February 2005 FDA rejects afamelanotide IND” clinuvel.com ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT05368857 | Jan 2022 → Feb 2023 | — | Clinuvel (UK) Ltd. | Completed | Met primary |
| Phase 1 | NCT01430195 | Jun 2011 → May 2012 | vitiligo | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 1 | NCT03634137 | Sep 2009 → Feb 2010 | — | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06388642 | Mar → Oct 2024 | erythropoietic protoporphyria | Clinuvel Europe Limited | Completed | No outcome recorded |
| Phase 212 trials · 1 met primary | ||||||
| Phase 2 | NCT05854784 | Mar → Dec 2023 | variegate porphyria | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT05210582 | Oct 2022 → Apr 2023 | vitiligo | Clinuvel, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05370235 | Mar 2022 → Jun 2024 | xeroderma pigmentosum | Clinuvel Europe Limited | Unknown | No outcome recorded |
| Phase 2 | NCT05159752 | Oct 2021 → Mar 2024 | xeroderma pigmentosum | Clinuvel Europe Limited | Unknown | No outcome recorded |
| Phase 2 | NCT04962503 | Jun 2021 → Feb 2022 | ischemic stroke | Clinuvel Pharmaceuticals Limited | Completed | Met primary |
| Phase 2 | NCT04525157 | Jun 2014 → Feb 2016 | vitiligo | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT01382589 | Sep 2011 → Jul 2012 | vitiligo | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT04943159 | Aug 2010 → Mar 2011 | acne | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT01097044 | Apr 2010 → Apr 2011 | erythropoietic protoporphyria | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT00859534 | Dec 2008 → Jun 2009 | solar urticaria | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT04425746 | Aug 2008 → May 2009 | — | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT00829192 | Nov 2007 → Jul 2012 | actinic keratosis, disease related to solid organ transplantation, squamous cell carcinoma | Clinuvel Pharmaceuticals Limited | Unknown | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT06109649 | Oct 2023 → Dec 2025 overdue | vitiligo | Clinuvel, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01605136 | May 2012 → Jul 2013 | erythropoietic protoporphyria | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 3 | NCT04578496 | Jul 2011 → Feb 2014 | erythropoietic protoporphyria | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 3 | NCT04704713 | May → Dec 2010 | polymorphic light eruption | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 3 | NCT00979745 | Sep 2009 → May 2011 | erythropoietic protoporphyria | Clinuvel Pharmaceuticals Limited | Completed | Met primary |
| Phase 3 | NCT04053270 | May 2007 → Dec 2009 | erythropoietic protoporphyria | Clinuvel Pharmaceuticals Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 72
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® approved for EPP in Canada clinuvel.com ↗ |
| 2026-04-27 | Clinuvel Pharmaceuticals Limited | Regulatory FDA relaxes SCENESSE® postmarketing requirement clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD today announced that the U.S. Food and Drug Administration (FDA) has reviewed the long-term safety profile of SCENESSE® (afamelanotide) and removed a requirement for a post- authorization phase I study on cardiac repolarization (a “QT study”). |
| 2026-04-24 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL receives final EMA scientific advice for pivotal Phase III vitiligo study clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD today announced that the European Medicines Agency (EMA) has provided final scientific advice on the design of the planned pivotal Phase III CUV107 study and anticipated evaluation of evidence of CLINUVEL’s drug SCENESSE® (afamelanotide) as a systemic vitiligo treatment. |
| 2026-04-02 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL reports highlights from AAD 2026 clinuvel.com ↗
The cases demonstrate repigmentation following 20 weeks of therapy with afamelanotide and adjunct narrowband ultraviolet B (NB-UVB) phototherapy, and maintenance of pigmentation in patients with darker skin types (Fitzpatrick IV-VI) after withdrawal of therapy for up to six months. |
| 2026-01-08 | Clinuvel Pharmaceuticals Limited | Results SCENESSE® efficacy in vitiligo: new cases presented at RDTC Conference clinuvel.com ↗
All patients reported satisfaction with the treatment, which was well tolerated. |
| 2025-10-16 | Clinuvel Pharmaceuticals Limited | Regulatory Health Canada requests additional time for review of SCENESSE® in EPP clinuvel.com ↗
CLINUVEL today announced that Health Canada has requested additional review time and information to complete its review of SCENESSE® (afamelanotide) for the treatment of adult patients with the rare metabolic disorder erythropoietic protoporphyria (EPP). |
| 2025-09-23 | Clinuvel Pharmaceuticals Limited | Regulatory EMA approves year-round SCENESSE® treatment clinuvel.com ↗
The European Medicines Agency (EMA) has agreed to amend the label for CLINUVEL’s photoprotective drug SCENESSE® (afamelanotide), enabling adult erythropoietic protoporphyria (EPP) patients to receive treatment every two months. |
| 2025-09-19 | Clinuvel Pharmaceuticals Limited | Results SCENESSE® efficacy in vitiligo: new cases presented to EADV clinuvel.com ↗
New patient cases demonstrating the efficacy of SCENESSE® (afamelanotide 16mg) in vitiligo patients have been presented to the European Academy of Dermatology and Venereology (EADV) conference in Paris, France. |
| 2025-06-18 | Clinuvel Pharmaceuticals Limited | Results Pilot study confirms adjunct NB-UVB needed to activate repigmentation in vitiligo clinuvel.com ↗
CLINUVEL today announced final results from its Phase II pilot study evaluating SCENESSE® (afamelanotide) as a monotherapy in patients with the depigmentation disorder vitiligo. |
| 2025-05-22 | Clinuvel Pharmaceuticals Limited | Results SCENESSE® EPP data featured at EADV Symposium clinuvel.com ↗
The adult HEP patient, treated under the care of the San Gallicano team, reported a positive clinical benefit from SCENESSE® treatment, alleviating phototoxic symptoms. |
| 2025-03-26 | Clinuvel Pharmaceuticals Limited | Results Positive preliminary results for PRÉNUMBRA® Instant in stroke patients clinuvel.com ↗
The drug was shown to be well tolerated in all nine participants. |
| 2025-02-10 | Clinuvel Pharmaceuticals Limited | Results Preliminary results from SCENESSE® adolescent EPP study clinuvel.com ↗
CLINUVEL today announced preliminary results from its post-authorisation study of SCENESSE® (afamelanotide) in adult and adolescent (12–17-year-old) erythropoietic protoporphyria (EPP) patients (CUV052). |
| 2025-01-20 | Clinuvel Pharmaceuticals Limited | Results CUV105 update — 4 case reports clinuvel.com ↗
As the randomised study CUV105 progresses, first observations are being shared by physicians and patients. |
| 2024-12-23 | Clinuvel Pharmaceuticals Limited | Regulatory Health Canada validates SCENESSE® New Drug Submission clinuvel.com ↗
CLINUVEL’s New Drug Submission (NDS) to Health Canada, seeking approval for its novel photoprotective therapy SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP), has been validated and accepted for review ahead of Health Canada’s target validation window. |
| 2024-10-01 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL files Canadian New Drug Submission for SCENESSE ® clinuvel.com ↗
CLINUVEL has filed a New Drug Submission (NDS) to Health Canada, seeking approval for its novel photoprotective therapy SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). |
| 2024-07-30 | Clinuvel Pharmaceuticals Limited | Results Technical note: CUV151 — DNA Repair program clinuvel.com ↗
This Technical Note explores the RNA-seq technique used and presents the results that demonstrate a broader role of afamelanotide in preventing and assisting repair in UV-induced skin damage than has been previously reported. |
| 2024-07-05 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide assists DNA repair response following UV radiation clinuvel.com ↗
CLINUVEL today announced the final set of results from a study (CUV151) evaluating the DNA -repair capacity of afamelanotide on skin of healthy volunteers exposed to ultraviolet (UV) radiation. |
| 2024-06-24 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® European Orphan Drug Designation for Variegate Porphyria clinuvel.com ↗
CLINUVEL’s drug afamelanotide has received a positive opinion for an orphan drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of variegate porphyria (VP). |
| 2024-06-03 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL withdraws SCENESSE® label expansion for adolescent erythropoietic protoporphyria clinuvel.com ↗
CLINUVEL has withdrawn a submission to expand its European marketing authorisation for SCENESSE® (afamelanotide) for adolescent patients with erythropoietic protoporphyria (EPP , absolute light intolerance). |
| 2024-04-29 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® European Orphan Drug Designation for Xeroderma Pigmentosum (XP) clinuvel.com ↗
CLINUVEL’s drug afamelanotide has received a positive opinion for an orphan drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of xeroderma pigmentosum (XP). |
| 2024-03-20 | Clinuvel Pharmaceuticals Limited | Results News Communiqué II clinuvel.com ↗
The team was most encouraged to see a new case study presented to the AAD from our vitiligo program, with the patient visibly responding well to treatment with a marked effect on quality of life. |
| 2024-03-11 | Clinuvel Pharmaceuticals Limited | Results SCENESSE ® clinuvel.com ↗
On 9 March, results were shared of a female patient treated systemically (total body) with SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) phototherapy. |
| 2024-03-04 | Clinuvel Pharmaceuticals Limited | Results SCENESSE ® clinuvel.com ↗
CLINUVEL today announced positive results from its first Phase II study evaluating SCENESSE® (afamelanotide 16mg) as a treatment for variegate porphyria (VP) patients. |
| 2023-09-05 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® in adolescent EPP study clinuvel.com ↗
Upon scientific review, the European Medicines Agency ( EMA) has requested further data from the use of SCENESSE® in adolescent patients to allow the label expansion. |
| 2023-08-15 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide Significantly Reduces DNA Damage in a Healthy Population clinuvel.com ↗
Biopsies of irra diated skin showed that DNA photodamage, expressed as bulky DNA ad ducts (cyclobutane pyrimidine dimers or CPDs), was significantly reduced at several time points following afamelanotide treatment, compared to baseline . |
| 2023-07-26 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® applied under five-year Veterans Affairs contract clinuvel.com ↗ |
| 2023-06-30 | Clinuvel Pharmaceuticals Limited | Regulatory Two grounds of Appeal upheld by NICE Panel clinuvel.com ↗ |
| 2023-05-09 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL escalates PRÉNUMBRA® to moderate/severe stroke patients clinuvel.com ↗
All three patients were admitted to specialist stroke centres with mild to moderate strokes (measured by the National Institutes of Health Stroke Scale 1, scores 1 -15) and showed functional improvement following PRÉNUMBRA® dosing, with the drug well tolerated. |
| 2023-03-17 | Clinuvel Pharmaceuticals Limited | Results DNA Repair data presented at American Academy of Dermatology Meeting clinuvel.com ↗
Initial r esults from CUV156 showed that a famelanotide was well tolerated and key markers of DNA photodamage , incl uding cyclobutane pyrimidine dimers (CPDs), were reduced following treatment. |
| 2023-02-02 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL Drug Significantly Reduces Critical UV Skin Damage in Fair-Skinned Individuals clinuvel.com ↗
The CUV151 study, conducted by Australian company CLINUVEL, treated nine fair-skinned volunteers with the photoprotective drug afamelanotide and showed that treatment could significantly reduce artificially provoked “sunburn damage” after just six days. |
| 2023-02-02 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide Significantly Reduces UV Skin Damage in a Healthy Population – Technical Note clinuvel.com ↗ |
| 2023-02-02 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide Significantly Reduces UV Skin Damage in a Healthy Population clinuvel.com ↗ |
| 2023-01-16 | Clinuvel Pharmaceuticals Limited | Results Media release: CLINUVEL Trial Results Show Drug Reduces DNA Damage clinuvel.com ↗
Our first clinical trial results demonstrate that afamelanotide in adult XP patients can reduce key markers of light and ultraviolet DNA damage, suggesting we may be able to reduce the risk and frequency of skin cancers in these patients. |
| 2023-01-16 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide Reduces DNA Photodamage in Xeroderma Pigmentosum – Technical Note clinuvel.com ↗ |
| 2023-01-16 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide Reduces DNA Photodamage in Xeroderma Pigmentosum clinuvel.com ↗
CLINUVEL today shared the first results of a phase II study (CUV156) evaluating afamelanotide in patients with xeroderma pigmentosum (XP) , a genetic disease characterised by a defect in DNA skin repair (NER1 defect). |
| 2022-09-05 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL submits SCENESSE® label expansion for adolescent EPP patients clinuvel.com ↗
CLINUVEL today announced that it has submitted a formal application to the European Medicines Agency (EMA) to expand the approved indication for SCENESSE® (afamelanotide 16mg) to include the treatment of adolescent erythropoietic protoporphyria (EPP) patients. |
| 2022-05-04 | Clinuvel Pharmaceuticals Limited | Results Positive final results in stroke clinuvel.com ↗
CLINUVEL today released positive final results of the open label pilot study (CUV801) in arterial ischemic stroke (AIS), evaluating multiple doses of CLINUVEL’s drug afamelanotide in six adult patients. |
| 2022-03-15 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide in stroke (AIS) – positive preliminary results clinuvel.com ↗
CLINUVEL today released positive preliminary results from its pilot study (CUV801) in arterial ischaemic stroke (AIS), evaluating afamelanotide in six adult patients. |
| 2022-01-24 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® continued in Germany clinuvel.com ↗
CLINUVEL today announced that it has entered a second agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the ongoing treatment and reimbursement of SCENESSE® (afamelanotide 16mg) in adult erythropoietic protoporphyria (EPP) patients. |
| 2021-08-10 | Clinuvel Pharmaceuticals Limited | Results Afamelanotide well tolerated by first stroke patients Afamelanotide in Arterial Ischemic Stroke – Phase II Study CUV801 clinuvel.com ↗ |
| 2021-02-11 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® Granted Market Access In Israel clinuvel.com ↗
CLINUVEL today announced that SCENESSE ® (afamelanotide 16mg) has been added to the expanded “National Health Basket” (NHB) of services and products reimbursable in Israel. |
| 2020-12-22 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL Newsletter VI clinuvel.com ↗
The DNA Repair Program is progressing since it has been confirmed that the first XP-C patient has completed the treatment and has not suffered any adverse reactions to SCENESSE® (afamelanotide 16mg). |
| 2020-10-27 | Clinuvel Pharmaceuticals Limited | Regulatory Media Release – TGA approves Australian drug to protect patients from light and sun clinuvel.com ↗
SCENESSE ® (afamelanotide) was developed by the Australian-led team to protect patients with the metabolic disorder erythropoietic protoporphyria (EPP) and will soon be listed on the Australian Therapeutic Goods Register following approval from the Therapeutic Goods Administration (TGA). |
| 2020-10-26 | Clinuvel Pharmaceuticals Limited | Results Update: SCENESSE® in DNA Repair clinuvel.com ↗
The patient tolerated the melanocortin drug well and no drug related adverse events have been reported. |
| 2020-08-28 | Clinuvel Pharmaceuticals Limited | Regulatory Corporate Presentation – 2020 Full Year Results clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD today announced that the Australian Therapeutic Goods Administration (TGA) has approved the registration of its drug SCENESSE ® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). |
| 2020-02-03 | Clinuvel Pharmaceuticals Limited | Regulatory Australian TGA commences SCENESSE® review clinuvel.com ↗
The TGA is now evaluating SCENESSE® under Priority Review as the first proposed therapy for adult patients with the rare metabolic disorder erythropoietic protoporphyria (EPP). |
| 2019-12-23 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® registration dossier submitted in Australia clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD today announced that it has submitted an application to the Australian Therapeutic Goods Administration (TGA) for its drug SCENESSE ® (afamelanotide 16mg) to be registered in the Australian Register of Therapeutic Goods (ARTG). |
| 2019-10-30 | Clinuvel Pharmaceuticals Limited | Regulatory TGA Priority Registration Pathway for SCENESSE clinuvel.com ↗ |
| 2019-10-09 | Clinuvel Pharmaceuticals Limited | Regulatory FDA Grants Marketing Approval For SCENESSE clinuvel.com ↗
It is a privilege for CLINUVEL PHARMACEUTICALS LTD to announce the US Food & Drug Administration (FDA) has granted marketing approval to use SCENESSE® (afamelanotide 16mg) for the treatment of EPP patients in the United States. |
| 2019-10-02 | Clinuvel Pharmaceuticals Limited | Regulatory FDA Clarifies SCENESSE® PDUFA Date clinuvel.com ↗
PDUFA goal date confirmed for 8 October 2019 |
| 2019-06-03 | Clinuvel Pharmaceuticals Limited | Regulatory US FDA extends PDUFA date for SCENESSE® clinuvel.com ↗ |
| 2019-06-03 | Clinuvel Pharmaceuticals Limited | Regulatory Media Release – US FDA review for SCENESSE® extended 3 months clinuvel.com ↗
The FDA also revised the expected date to provide commentary on product labelling and CLINUVEL’s post -marketing authorisation commitments to 6 September. |
| 2019-01-15 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL Newsletter – January 2019 clinuvel.com ↗
We learnt on 9 January that the US Food and Drug Administration (FDA) has now completed its filing review of the New Drug Application submitted in 2018 and set a target review date of 8 July 2019 under the Prescription Drug User Fee Act (PDUFA). |
| 2019-01-10 | Clinuvel Pharmaceuticals Limited | Regulatory US FDA sets PDUFA date for SCENESSE® clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a Prescription Drug User Fee Act (PDUFA) date of 8 July 2019. |
| 2018-12-19 | Clinuvel Pharmaceuticals Limited | Results CUV103 Singaporean Phase II vitiligo study results clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD today announced results of the CUV103 phase II clinical trial conducted at the National Skin Centre in Singapore which evaluated the use of SCENESSE® (afamelanotide 16mg) in vitiligo patients of Asian ethnicity. |
| 2018-12-19 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL Vitiligo Communiqué clinuvel.com ↗
By using the Vitiligo Area Scoring Index (VASI) and photography before and after treatment it was shown that repigmentation occurred homogenously over the body surface. |
| 2018-10-10 | Clinuvel Pharmaceuticals Limited | Regulatory Appeal Upheld Against NICE Recommendation in England clinuvel.com ↗ |
| 2018-09-05 | Clinuvel Pharmaceuticals Limited | Regulatory US FDA Update clinuvel.com ↗ |
| 2018-06-25 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL COMPLETES SCENESSE® FDA FILING clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XET RA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY ) today announced that it has completed the submission of a New Drug Application (NDA) for its drug SCENESSE® (afamelanotide 16 mg) as the first proposed therapy for patients with the rare metabolic disorder erythropoietic protoporphyria (EPP) in the United States. |
| 2018-05-23 | Clinuvel Pharmaceuticals Limited | Regulatory NICE MAINTAINS ITS POSITION NOT TO RECOMMEND SCENESSE® FOR REIMBURSEMENT clinuvel.com ↗ |
| 2018-05-14 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL REGULATORY UPDATE clinuvel.com ↗ |
| 2018-03-26 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL Newsletter – March 2018 clinuvel.com ↗
Under the Post-Authorisation Safety Study (PASS) the high percentage of patient continuation after 13 months of treatment – 06 June 2016 to 30 June 20 17 – was discussed in Vienna, as well as the unexpectedly high demand for further treatment during autumn and winter. |
| 2018-03-19 | Clinuvel Pharmaceuticals Limited | Results CLINUVEL HOLDS EUROPEAN ERYTHROPOIETIC PROTOPORPHYRIA (EPP) EXPERT MEETING clinuvel.com ↗
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA -DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced the results of the third European meeting on erythropoietic protoporphyria (EPP) held in Vienna, Austria, on Friday 16 March. |
| 2017-12-20 | Clinuvel Pharmaceuticals Limited | Regulatory Preliminary recommendation by NICE not to include SCENESSE® for reimbursement by NHS England clinuvel.com ↗
A final recommendation is expected to be made by the HST Committee in May 2018. |
| 2017-04-11 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL reaches agreement on German SCENESSE® pricing through AMNOG Arbitration Board clinuvel.com ↗ |
| 2016-10-16 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® NICE ENGLAND UPDATE clinuvel.com ↗
NICE has made a recommendation to the UK Department of Health that SCENESSE® is to be evaluated under the Single Technology Appraisal (STA) procedure. |
| 2016-10-13 | Clinuvel Pharmaceuticals Limited | Regulatory FDA SCHEDULES PRE-NDA MEETING FOR SCENESSE® clinuvel.com ↗ |
| 2016-07-17 | Clinuvel Pharmaceuticals Limited | Regulatory FDA accepts SCENESSE® clinical data package for NDA submission clinuvel.com ↗
The FDA has deemed Clinuvel’s clinical data package satisfactory for submitting a New Drug Application (NDA). |
| 2016-07-05 | Clinuvel Pharmaceuticals Limited | Regulatory FDA awards SCENESSE® Fast Track designation for treatment of EPP clinuvel.com ↗ |
| 2016-06-20 | Clinuvel Pharmaceuticals Limited | Regulatory CLINUVEL’s SCENESSE® launched in Europe clinuvel.com ↗
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has been launched in Europe, with the first commercial delivery of the product under European marketing authorisation. |
| 2016-03-23 | Clinuvel Pharmaceuticals Limited | Regulatory NICE Highly Specialised Technology workshop reviews SCENESSE® clinuvel.com ↗ |
| 2016-02-10 | Clinuvel Pharmaceuticals Limited | Regulatory SCENESSE® receives US FDA orphan designation for cutaneous porphyrias clinuvel.com ↗
today announced that its lead drug SCENESSE® (afamelanotide 16mg) has received an additional orpha n drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of cutaneous variants of porphyria. |
All press releases naming this drug 105 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 105 releases opens the full record — a long page | ||
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Afamelanotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04053270 ↗ |
| Known as | (nle4,d-phe7)-.alpha.-msh | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | A-melanotropin, 4(nle)-7(d-phe) | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | Afamelanotida | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | AFAMELANOTIDE ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | Afamelanotide triacetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | CUV-1647 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | CUV1647 | “The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic...” NCT04425746 ↗1“Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months” NCT00829192 ↗ |
| Known as | Melanotan | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | Melanotan i | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | Melanotan-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | Ndp-alpha-msh | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Known as | Scenesse | ChEMBL registry synonym — accepted as the source's own label CHEMBL441738 ↗ |
| Action | Activate | “Melanocortin receptor 1 agonist” CHEMBL441738 ↗ |
| Modality | Peptide | “We evaluated the safety and efficacy of an α-melanocyte-stimulating hormone analogue, afamelanotide, to decrease pain and improve quality of life.” PMID 26132941 ↗ Jul 2015 |
| Route | Subcutaneous | “Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months” NCT00829192 ↗ |
| Target | MC1R | “Melanocortin receptor 1 agonist” CHEMBL441738 ↗ |