Scientific Summary: Proven & Potential Indications - Clinuvel's Drug Pipeline


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A thread to summarise known/potential indications for Clinuvel's drug pipeline.

CountMedical ConditionAlso Known AsICD-10 CodeICD-10 Main CategoriesDrug Generic NameDrug Brand NameODD?StatusNotes
1CholangiocarcinomaBile duct cancerC22.1NeoplasmsafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV025
2Squamous cell carcinoma (SCC)SCC, SCC skin cancer, non-melanoma skin cancer, NMSCC44NeoplasmsafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV011
3Basal cell carcinoma (BCC)BCC, basal-cell skin cancer, basaliomaC44NeoplasmsafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV011
4SarcoidosisSarcoïdosis, sarcoid, Besnier-Boeck-Schaumann diseaseD86Blood, Blood-forming Organs, ImmuneafamelanotideSCENESSEPreclinical researchLink to research
5Erythropoietic Protoporphyria (EPP)EPP, protoporphyria, erythropoietic porphyriaE80.0Endocrine, Nutritional, MetabolicafamelanotideSCENESSEYApproved/Treating - EMA, FDALink to approval
6Erythropoietic protoporphyria (EPP) - paediatricEPP, protoporphyria, erythropoietic porphyriaE80.0Endocrine, Nutritional, MetabolicafamelanotideSCENESSE ENFANCEPreclinical researchLink to source
7Congenital erythropoietic porphyria (CEP)CEP, Gunther’s disease, Uroporphyrinogen III synthase deficiency, UROS deficiency, Congenital porphyria, Congenital hematoporphyria, Erythropoietic uroporphyriaE80.0Endocrine, Nutritional, MetabolicafamelanotideSCENESSEYTreating? - CompassionateLink to source
8X-Linked protoporphyria (XLDPP)X-Linked Protoporphyria. XLDPP; X-linked dominant protoporphyria; XLPE80.0Endocrine, Nutritional, MetabolicafamelanotideSCENESSEApproved/Treating?Link to source
9Variegate porphyria (VP)VP, Mixed hepatic porphyria, Mixed porphyria, South African genetic porphyria, and South African porphyria.E80.2Endocrine, Nutritional, MetabolicafamelanotideSCENESSEYClinical trial - Phase 2Link to trial - CUV040
10Hereditary coproporphyria (HCP)HCPE80.2Endocrine, Nutritional, MetabolicafamelanotideSCENESSEYPreclinical researchLink to source
11DementiaSenility, senile dementiaF03Mental and Behavioral DisordersafamelanotideSCENESSEPreclinical researchLink to research
12Huntington's diseaseHuntington's choreaG10Nervous SystemafamelanotideSCENESSEPreclinical researchLink to research
13Amyotrophic lateral sclerosis (ALS)Motor neurone disease (MND), Lou Gehrig's diseaseG12.2Nervous SystemafamelanotideSCENESSEPreclinical researchLink to research
14Parkinson's diseasePrimary parkinsonism, paralysis agitans, or idiopathic parkinsonismG20Nervous SystemafamelanotideSCENESSEPreclinical researchLink to research
15Alzheimer's diseaseAlzheimer disease, Alzheimer'sG30.9Nervous SystemafamelanotideSCENESSEPreclinical researchLink to research
16Multiple Sclerosis (MS)Disseminated sclerosis, encephalomyelitis disseminataG35Nervous SystemafamelanotideSCENESSEPreclinical researchLink to research
17Cardiac Arrest (CA)CA, Cardiopulmonary Resuscitation (CPR)I46Circulatory SystemafamelanotidePRENUMBRA?Preclinical researchLink to research
18Arterial Ischaemic StrokeCerebral thrombosis, cerebral infarctionI63Circulatory SystemafamelanotideSCENESSEClinical trial - Phase 2aLink to trial - CUV801
19AtherosclerosisArteriosclerosis, atherosclerotic cardiovascular diseaseI70Circulatory SystemafamelanotideSCENESSEPreclinical researchLink to research
20Barrett's oesophagusAllison-Johnstone anomaly, columnar epithelium lined lower oesophagus (CELLO)K22.7Digestive SystemafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV025
21PsoriasisPsoriasis vulgaris, chronic stationary psoriasis, plaque-like psoriasisL40Skin and Subcutaneous TissueafamelanotideSCENESSEPreclinical researchLink to research
22Phototoxicity(Phototoxicity from photodynamic therapy)L56.0Skin and Subcutaneous TissueafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV025
23Solar urticaria (SU)SUL56.3Skin and Subcutaneous TissueafamelanotideSCENESSEYClinical trial - Phase 2Link to trial - CUV016
24Polymorphic light eruption (PLE)PLE, PMLE, sun sickness, sun allergyL56.4Skin and Subcutaneous TissueafamelanotideSCENESSEClinical trial - Phase 3Link to trial - CUV015
25Actinic keratoses (AK)AK, Solar Keratosis, SK, senile keratosisL57.0Skin and Subcutaneous TissueafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV011
26Acne vulgarisPimples, zits, whiteheads, blackheadsL70.0Skin and Subcutaneous TissueafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV100
27Hidradenitis suppurativa (HS)HS, acne inversaL73.2Skin and Subcutaneous TissueafamelanotidePRENUMBRA?Preclinical researchLink to research
28VitiligoNonsegmental vitiligo, Leucoderma, white spot diseaseL80Skin and Subcutaneous TissueafamelanotideSCENESSEClinical trial - Phase 2Link to trial - CUV102
29Xeroderma pigmentosum (XP)XPQ82.1Congenital Malformations, Deformations and Chromosomal AbnormalitiesafamelanotideSCENESSEClinical trial - Phase 2Link to source
30Hailey-hailey disease (HHD)HHD, benign chronic pemphigusQ82.8Congenital Malformations, Deformations and Chromosomal AbnormalitiesafamelanotideSCENESSEYClinical trial - Phase 2Link to trial - HHD_SCENESSE
31VitiligoNonsegmental vitiligo, Leucoderma, white spot diseaseL80Skin and Subcutaneous TissueparvysmelanotideVLRX001Topical / transdermal
32Crohn's diseaseInflammatory bowel disease, irritable bowel syndromeK50Digestive SystemafamelanotideSCENESSEPreclinical researchLink to research
33OsteoarthritisArthritisM15.9Musculoskeletal and Connective TissueafamelanotideSCENESSEPreclinical researchLink to research
34Rheumatoid arthritisArthritisM06Musculoskeletal and Connective TissueafamelanotideSCENESSEPreclinical researchLink to research
37?OTC 1 - CHIVÉRE?Launch 2021Polychromatic protection
38?OTC 2 - T'SUMOYL?DNA protection & repair

Thanks to @uhohinc for his info on Google Groups, it helped greatly with this summary.

Note: The coloured text, green and orange, indicate conditions already Approved/Treating (green) or formally announced as being pursued by Clinuvel (orange).
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Note: "According to the MedDRA user guide,17 each PT must be linked to at least 1 SOC, and a PT can be linked to as many SOCs as appropriate. This indicates that each PT could be grouped under more than 1 SOC. It results from the lack of a well-defined hierarchical structure in MedDRA."

OrderSystem Organ Class (SOC)
Infections and infestations
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blood and lymphatic system disorders
Immune system disorders
Endocrine disorders
Metabolism and nutrition disorders
Psychiatric disorders
Nervous system disorders
Eye disorders
Ear and labyrinth disorders
Cardiac disorders
Vascular disorders
Respiratory, thoracic and mediastinal disorders
Gastrointestinal disorders
Hepatobiliary disorders
Skin and subcutaneous tissue disorders
Musculoskeletal and connective tissue disorders
Renal and urinary disorders
Pregnancy, puerperium and perinatal conditions
Reproductive system and breast disorders
Congenital, familial and genetic disorders
General disorders and administration site conditions
Injury, poisoning and procedural complications
Surgical and medical procedures
Social circumstances
Product issues
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Medical Dictionary for Regulatory Activities
Version 4.0 June 2001



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WHO - Classification of Diseases
International Statistical Classification of Diseases and Related Health Problems 10th Revision

This may be better, as it is publicly available and CUV seem to already use it...
Last edited:


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Edit: 30 Sep 2020, I removed and updated the table in the first post of the thread (the old table had negligible info) the current table will be used as a base.
Note: We may need to think of another way to summarise I had to remove several columns of info (Medical Condition Also Known As, Orphan Drug Designation, Generic Drug Name, etc) as the post was restricted to 10,000 characters. Perhaps this limit includes characters in the URL links?


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Edit: 05 Oct 2020, added additional columns to the summary table.

Also Known AsDrug Generic NameODD? (Orphan Drug Designation)


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Edit: 03 Nov 2020

  • Changed colour of Arterial Ischemic Stroke line item to orange to indicate Clinuvel is formally going after this indication
  • Added information to the parvysmelanotide (VLRX001) line to indicate this will be used as an adjuvant for vitiligo and will be topical / self administered and prescription (Rx)
  • Added information about the first OTC product, polychromatic protection to be launched in 2021

CUV Quote (Yesterday's close)

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