New Active Substance approvals
Approvals as of 31 December 2025:
The Access Consortium will update the below lists periodically in Q1 of each year, for the previous year. Products included are those approved by at least two agencies after an Access Consortium work-sharing procedure.
New Active Substances
Access Pathway (NI = New Indication) | Trade Name | Active Substance | Year of First Approval | Participating Agencies | Therapeutic Area |
Priority | Erleada[i] | Apalutamide | 2018 | HC/TGA | Endocrine Therapy |
Standard | Verzenio | Abemaciclib | 2019 | HC/TGA | Antineoplastic Agents |
Standard | Zejula | Niraparib | 2019 | HC/TGA | Antineoplastic Agents |
Standard | Xofluza | Baloxavir marboxil | 2020 | HC/SMC/TGA | Antivirals for Systemic Use |
Standard | Nubeqa | Darolutamide | 2020 | HC/TGA | Endocrine Therapy |
Standard | Vyndaqel | Tafamidis | 2020 | HSA/TGA | Other Nervous System Drugs |
Standard | Sarclisa | Isatuximab | 2020 | HC/TGA | Antineoplastic Agents |
Standard | Kesimpta | Ofatumumab | 2021 | HC/HSA/SMC/TGA | Immunosuppressants |
Standard | VeraSeal fibrin sealant | Human fibrinogen, human thrombin | 2021 | HC/SMC/TGA | Antihemorrhagics |
Standard | Verquvo | Vericiguat | 2021 | HSA/SMC/TGA | Cardiac Therapy |
Standard | Leqvio | Inclisiran | 2021 | HC/HSA/TGA | Lipid Modifying Agents |
Standard - NI | Sarclisa | Isatuximab | 2021 | HC/TGA | Antineoplastic Agents |
Standard | Nexviadyme | Avalglucosidase alfa | 2021 | HC/SMC/TGA | Other Alimentary Tract and Metabolism Products |
Standard - NI | Libtayo | Cemiplimab | 2021 | HC/TGA | Antineoplastic Agents |
Standard | Kerendia | Finerenone | 2021 | HSA/SMC/TGA | Diuretics |
Standard | Somatrogon[ii] | Human growth hormone | 2021 | HC/TGA | Pituitary and Hypothalamic Hormones and Analogues |
Standard - NI | Maviret | Glecaprevir / Pibrentasvir | 2021 | HC/TGA | Antivirals for Systemic Use |
Standard | Cibinqo | Abrocitinib | 2022 | HSA/SMC | Other Dermatological Preparations |
Standard - NI | Skyrizi | Risankizumab | 2022 | HSA/TGA | Immunosuppressants |
Standard | Tavneos | Avacopan | 2022 | HC/SMC | Immunosuppressants |
Standard - NI | Dupixent | Dupilumab | 2022 | HC/HSA/SMC/TGA | Other Dermatological Preparations |
Standard | Scemblix | Asciminib | 2022 | HC/HSA/MHRA/SMC/TGA | Antineoplastic Agents |
Standard | Vabysmo | Faricimab | 2022 | HC/HSA/MHRA/SMC/TGA | Ophthalmologicals |
Standard | Korsuva/Kapruvia | Difelikefalin | 2022 | HC/HSA/SMC/TGA | All Other Therapeutic Products |
Standard | Mounjaro | Tirzepatide | 2022 | HC/HSA/SMC/TGA | Drugs used in Diabetes |
Standard | Vafseo | Vadadustat | 2023 | MHRA/SMC/TGA | Antianemic Preparations |
Standard - NI | Vaxchora | Vibrio cholerae vaccine strain CVD 103-HgR | 2023 | HC/TGA | Vaccines |
Standard - NI | Dupixent | Dupilumab | 2023 | HC/HSA/SMC/TGA | Other Dermatological Preparations |
Standard - NI | Orkambi Granule | Lumacaftor / Ivacaftor | 2023 | HC/MHRA/TGA | Other Respiratory System Products |
Standard | Omvoh | Mirikizumab | 2023 | SMC/TGA | Immunosuppressants |
Priority | Alhemo | Concizumab | 2023 | HC/SMC/TGA | Antihemorrhagics |
Standard - NI | Alhemo | Concizumab | 2023 | HC/SMC/TGA | Antihemorrhagics |
Standard | Veoza | Fezolinetant | 2023 | SMC/TGA | Other Gynecologicals |
Standard | Awiqli | Insulin icodec | 2024 | HC/SMC/TGA | Drugs used in Diabetes |
Standard - NI | Brukinsa | Zanubrutinib | 2024 | HC/MHRA/SMC | Antineoplastic Agents |
Standard | Velsipity | Etrasimod L-arginine | 2024 | HSA/SMC | Immunosuppressants |
Standard - NI | Vabysmo | Faricimab | 2024 | HC/HSA/MHRA/SMC/TGA | Ophthalmologicals |
Standard | Sydapvia[iii] | Dapagliflozin / Sitagliptin | 2024 | HSA/TGA | Drugs used in Diabetes |
Standard - NI | Rexulti | Brexpiprazole | 2024 | HSA/SMC/TGA | Psycholeptics |
Priority | Winrevair | Sotatercept | 2024 | HC/HSA/SMC/TGA | Antihypertensives |
Standard | Fruzaqla | Fruquintinib | 2024 | HC/HSA/MHRA/SMC/TGA | Antineoplastic Agents |
Standard | Hympavzi | Marstacimab | 2024 | HSA/SMC/TGA | Antithrombotic Agents |
Standard - NI | Opsumit | Macitentan | 2024 | HC/MHRA | Antihypertensives |
Standard | Rystiggo | Rozanolixizumab | 2025 | HC/SMC/TGA | Immunosuppressants |
Standard | Andembry | Garadacimab | 2025 | HC/MHRA/SMC/TGA | Other Hematological Agents |
Standard | Kisunla | Donanemab | 2025 | HSA/SMC/TGA | Psychoanaleptics |
Standard | Vyloy | Zolbetuximab | 2025 | HSA/SMC/TGA | Antineoplastic Agents |
Standard | Nemluvio | Nemolizumab | 2025 | HSA/MHRA/SMC/TGA | Other Dermatological Preparations |
Standard | Datroway | Datopotamab deruxtecan | 2025 | HSA/SMC/TGA | Antineoplastic Agents |
Priority - NI | Dupixent | Dupilumab | 2025 | HSA/SMC/TGA | Other Dermatological Preparations |
Standard - NI | Sarclisa | Isatuximab | 2025 | HSA/SMC | Antineoplastic Agents |
Standard | Lynkuet | Elinzanetant | 2025 | HC/MHRA/SMC/TGA | Other Gynecologicals |
Standard - NI | Tremfya | Guselkumab | 2025 | HSA/SMC | Immunosuppressants |
Standard - NI | Omvoh | Mirikizumab | 2025 | SMC/TGA | Immunosuppressants |
Standard | Ekterly | Sebetralstat | 2025 | HSA/MHRA/SMC/TGA | Other Hematological Agents |
Standard | Imaavy | Nipocalimab | 2025 | HC/SMC | Immunosuppressants |
Standard - NI | Dupixent | Dupilumab | 2025 | HC/HSA/MHRA | Other Dermatological Preparations |
Notes
[i] Trade Name in AU is Erlyand
[ii] Trade Name in AU is Ngenla
[iii] Trade Name in AU is Sidapvia