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

investek

Well-known member
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
18Ischemic strokeCerebral thrombosis, cerebral infarctionI63Circulatory SystemafamelanotidePRENUMBRA?Preclinical researchLink to research
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
31parvysmelanotideVLRX001
32phimelanotideVLRX002
33?CUV9900
34?OTC - CHIVÉRE?
35?OTC - T'SUMOYL?

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).
 
Last edited:

investek

Well-known member

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)
1​
Infections and infestations
2​
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
3​
Blood and lymphatic system disorders
4​
Immune system disorders
5​
Endocrine disorders
6​
Metabolism and nutrition disorders
7​
Psychiatric disorders
8​
Nervous system disorders
9​
Eye disorders
10​
Ear and labyrinth disorders
11​
Cardiac disorders
12​
Vascular disorders
13​
Respiratory, thoracic and mediastinal disorders
14​
Gastrointestinal disorders
15​
Hepatobiliary disorders
16​
Skin and subcutaneous tissue disorders
17​
Musculoskeletal and connective tissue disorders
18​
Renal and urinary disorders
19​
Pregnancy, puerperium and perinatal conditions
20​
Reproductive system and breast disorders
21​
Congenital, familial and genetic disorders
22​
General disorders and administration site conditions
23​
Investigations
24​
Injury, poisoning and procedural complications
25​
Surgical and medical procedures
26​
Social circumstances
27​
Product issues
 
Last edited:

investek

Well-known member
Medical Dictionary for Regulatory Activities
MedDRA
Version 4.0 June 2001

ftp://ftp1.nci.nih.gov/pub/NCICB/evspub/Documentation/MedDRA4_0/intguide.pdf
 

Attachments

investek

Well-known member
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:

investek

Well-known member
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?
 

investek

Well-known member
Edit: 05 Oct 2020, added additional columns to the summary table.

Also Known AsDrug Generic NameODD? (Orphan Drug Designation)
 

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