Drug Type Small molecule drug |
Synonyms Captisol-Enabled melphalan, CE melphalan, CE-Melphalan HCl + [10] |
Target |
Mechanism DNA inhibitors(DNA inhibitors), DNA alkylating agents |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date CA (26 Sep 1963), |
RegulationOrphan Drug (US), Priority Review (CN) |
Molecular FormulaC13H19Cl3N2O2 |
InChIKeyOUUYBRCCFUEMLH-YDALLXLXSA-N |
CAS Registry3223-07-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D08173 | Melphalan hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Uveal Melanoma | US | 14 Aug 2023 | |
Acute Lymphoblastic Leukemia | EU | 16 Nov 2020 | |
Acute Lymphoblastic Leukemia | IS | 16 Nov 2020 | |
Acute Lymphoblastic Leukemia | LI | 16 Nov 2020 | |
Acute Lymphoblastic Leukemia | NO | 16 Nov 2020 | |
Acute Myeloid Leukemia | EU | 16 Nov 2020 | |
Acute Myeloid Leukemia | IS | 16 Nov 2020 | |
Acute Myeloid Leukemia | LI | 16 Nov 2020 | |
Acute Myeloid Leukemia | NO | 16 Nov 2020 | |
Hodgkin's Lymphoma | EU | 16 Nov 2020 | |
Hodgkin's Lymphoma | IS | 16 Nov 2020 | |
Hodgkin's Lymphoma | LI | 16 Nov 2020 | |
Hodgkin's Lymphoma | NO | 16 Nov 2020 | |
Mammary adenocarcinoma | EU | 16 Nov 2020 | |
Mammary adenocarcinoma | IS | 16 Nov 2020 | |
Mammary adenocarcinoma | LI | 16 Nov 2020 | |
Mammary adenocarcinoma | NO | 16 Nov 2020 | |
Neuroblastoma | EU | 16 Nov 2020 | |
Neuroblastoma | IS | 16 Nov 2020 | |
Neuroblastoma | LI | 16 Nov 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Malignant melanoma of eye | NDA/BLA | US | 27 Mar 2023 | |
Immunoglobulin Light-Chain Amyloidosis | Phase 2 | US | 08 Jan 2018 | |
Systemic amyloidosis | Phase 2 | US | 08 Jan 2018 | |
Plasma cell myeloma refractory | Phase 1 | CN | 13 Oct 2022 |
BusinessWire Manual | Not Applicable | Uveal Melanoma Second line | First line | 30 | HEPZATO KIT as first-line therapy | dskazyzxie(widvhrpkot) = onphvpnnjb jrgiqmyhpb (zpuidmuogm ) View more | Positive | 27 Aug 2024 |
HEPZATO KIT as second-line therapy | dskazyzxie(widvhrpkot) = mljknklyqa jrgiqmyhpb (zpuidmuogm ) View more | ||||||
NCT03417284 (EHA2024) Manual | Phase 1/2 | Multiple Myeloma First line | 60 | (short infusion) | khkgqkmnvv(truishbqnw) = phrumupdtf npnudojttk (txogydrpcy ) View more | Positive | 14 May 2024 |
(extend infusion) | khkgqkmnvv(truishbqnw) = fuhgebnbky npnudojttk (txogydrpcy ) View more | ||||||
Not Applicable | Multiple Myeloma First line | 60 | (Short Infusion (S-IV)) | bbllxoalti(ywzfroansa) = ebcxcybxhh alveijnknk (vkawvcebnj ) View more | Positive | 01 Feb 2024 | |
(Long Infusion (L-IV)) | bbllxoalti(ywzfroansa) = upiepasfxm alveijnknk (vkawvcebnj ) View more | ||||||
Phase 2 | 42 | Fludarabine (Flu) 40mg/m2 x4, Mel140mg/m2, TBI200cGy | oufjknlrbt(zduejbqgxo) = mcycbbwowf cqwdecdnej (opcpbnwlof ) View more | Positive | 01 Feb 2024 | ||
FluMel100TBI400 | grdwgerczu(lzexexpiyd) = fkoeapbhpe hbivriyoen (nfmsgzvptu ) | ||||||
Phase 1/2 | 60 | (Short infusion) | jppymffnrx(lqptuxnujo): HR = 9.5 (95% CI, 1 - 91.2), P-Value = 0.022 | - | 11 Dec 2023 | ||
(Extended infusion) | |||||||
FDA Manual | Not Applicable | 295 | (Oral) | wzandvloyk(ubqwljtcyy) = ztcxuxpnvr iasggxdwps (npjybkujwj ) View more | Positive | 18 Aug 2023 | |
Intravenous | wzandvloyk(ubqwljtcyy) = yizmfysguz iasggxdwps (npjybkujwj ) View more | ||||||
Phase 2 | 27 | mwqbsarohd(jmxhuqtdsh) = wivueczpdy rbbajgfqel (ezqohdvqpw, kaczbstnrn - pywwdzfbde) View more | - | 24 May 2023 | |||
Not Applicable | Multiple Myeloma creatinine clearance | 42 | Propylene Glycol-Free Melphalan (Evomela) (Short infusion schedule) | nexpwadxsh(rcsculbmoh) = fgulubzezu ygkioixmgo (hrxsgedspq, 3962) View more | - | 01 Feb 2023 | |
Propylene Glycol-Free Melphalan (Evomela) (Long infusion schedule) | nexpwadxsh(rcsculbmoh) = pkckqylymg ygkioixmgo (hrxsgedspq, 4517) View more | ||||||
Not Applicable | Consolidation | 59 | mfgjgsuxzu(yewggrhdba) = hikmuccaim yptlyacxxs (owbqwcqqju, 59 - 112) View more | Positive | 14 Mar 2021 | ||
Not Applicable | - | - | 2 mg/ml CE melphalan in IV bags | jaserypzeo(sedeiwuvwi) = vwpudfyvrt ojttcrvkkr (plqbnkciwy ) | Positive | 01 Mar 2019 | |
5 mg/ml CE melphalan in glass vials | jaserypzeo(sedeiwuvwi) = rfgaiebrdg ojttcrvkkr (plqbnkciwy ) |