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Enable Injections Announces Approval in Japan for CirCLIQ® Injector based on enFuse® On-Body Delivery System

GlobeNewswire

Sanofi's CirCLIQ® Injector, developed using enFuse technology, has been approved to administer Sarclisa subcutaneous formulation, in combination with approved standard-of-care regimens, for patients with multiple myeloma

October 19, 2026 08:04 ET  | Source: Enable Injections, Inc.

CINCINNATI, Oct. 19, 2026 -- Enable Injections, Inc. (“Enable”), a leader in wearable drug delivery technologies, today announced the first regulatory approval of its enFuse® On-Body Delivery System technology by Japan’s Ministry of Health, Labour and Welfare through Sanofi's CirCLIQ® Injector for the administration of Sarclisa (isatuximab) subcutaneous (SC) formulation, in combination with approved standard-of-care regimens, for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

The approval marks Enable's first commercial product approval in Japan and the first anticancer treatment to be administered via an on-body injector (OBI) in the country. It further expands the global reach of Enable's enFuse technology through the CirCLIQ Injector following recent approvals in the United States and Europe.

“This approval is another important milestone in our mission to expand access to novel drug delivery solutions around the world,” said Michael D. Hooven, Chairman and CEO of Enable Injections. “We're proud to partner with Sanofi to bring our enFuse technology to patients in Japan and to support an innovative treatment option for people living with multiple myeloma. As the adoption of subcutaneous delivery continues to grow globally, we're excited to help our pharmaceutical partners bring more therapies to patients.”

The CirCLIQ Injector, developed using Enable's enFuse technology, is designed to subcutaneously deliver Sarclisa with the push of a button. The OBI uses a hidden, retractable needle that is shorter and thinner compared to the needles commonly used for large-volume subcutaneous injections.

The Japan approval of Sarclisa SC in June 2026 was supported by results from the IRAKLIA phase 3 study in R/R MM, which demonstrated the non-inferiority of the SC formulation compared to intravenous, as well as supportive studies. The studies evaluated Sarclisa SC administered through both manual SC administration and an OBI based on enFuse technology.

Enable partners with leading biopharmaceutical companies to deliver medication using its enFuse System, enabling the subcutaneous delivery of large-volume biologic therapies across a growing range of therapeutic areas, including oncology, hematology, immunology, and rare disease.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse® On-Body Delivery System. An innovative wearable technology, the enFuse System is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. For more information, visit www.enableinjections.com.

About Sarclisa
Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.

Sarclisa SC (Sarclisa Escena in the US), the subcutaneous formulation of Sarclisa, is approved in the US, in the EU, Japan and in the UK, in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Contact:

Jenn Beeson
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