medmix' Drug Delivery ("Haselmeier") to Support the Development of Xeris Pharmaceuticals' XP-8121 with D-Flex(TM) Pen Injector
medmix’ D-Flex pen injector is selected for Xeris’ XP-8121 levothyroxine candidate, underscoring the need for highly accurate delivery of NTI drugs.
Rhea-AI Summary
medmix (MDMXF) will support Xeris Pharmaceuticals' investigational XP-8121 once-weekly levothyroxine therapy for hypothyroidism with its D-Flex™ disposable pen injector platform.
XP-8121 combines Xeris' high-concentration XeriSol® levothyroxine formulation with an adjustable pen designed to deliver precise fixed doses. In design verification testing, D-Flex™ achieved dose accuracy that significantly exceeded ISO 11608-1 requirements for needle-based injection systems. The platform's patented dosing mechanism allows only intended dose settings, supports multiple fixed-dose configurations, delivers very small increments down to 0.005 mL, and can be adapted for volumes up to 0.75 mL. D-Flex™ has been marketed since 2023, is backed by established manufacturing and supply infrastructure, and is already used in an approved European product variant and an ongoing U.S. clinical program.
Positive
- D-Flex™ dose accuracy significantly exceeded ISO 11608-1 requirements in design verification testing
- Dosing flexibility with fixed-dose configurations, 0.005 mL increments and up to 0.75 mL volume
- Reduced device-related novelty as D-Flex™ is marketed since 2023 with established manufacturing and supply
- Clinical and commercial use already in an approved European product variant and an ongoing U.S. clinical program
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Baar, Switzerland--(Newsfile Corp. - September 10, 2026) - medmix’ Drug Delivery (“Haselmeier”) announces its collaboration with Xeris Pharmaceuticals to support the development of Xeris’ XP-8121 product candidate, an investigational once-weekly subcutaneous levothyroxine therapy in development for the treatment of hypothyroidism. XP-8121 combines a proprietary high-concentration XeriSol® levothyroxine formulation with an adjustable pen injector designed to deliver precise fixed doses depending on the patient's needs. The collaboration leverages the D-Flex™ disposable pen platform, which combines precise dose delivery with a unique dosing technology. In design verification testing, D-Flex™ achieved dose accuracy significantly exceeding ISO 11608-1 requirements.
As levothyroxine has been classified by the U.S. Food and Drug Administration as a drug with a narrow therapeutic index (NTI), accurate dose delivery is critical, and small differences in dose or blood concentration can lead to over- or undertreatment and adverse effects. For this reason, device performance plays an important role in supporting the overall safety, efficacy, and reliability of the drug-device combination.
The high dose accuracy performance was demonstrated in recent design verification testing against ISO 11608-1, the international standard for dose accuracy within needle-based injection systems. These results provide additional confidence for pharmaceutical companies developing therapies for which dosing precision is particularly important. Beyond the technical achievement, they underline the role delivery devices can play in enabling the development of innovative medicines with specific administration requirements.
Past the scope of its dose accuracy performance, the D-Flex™ platform incorporates a patented dosing mechanism that allows patients to select only intended dose settings. Intermediate doses cannot be selected, reducing the potential for dosing errors. The platform supports multiple fixed-dose configurations within a single device design and enables the administration of very small dose increments of down to 0.005 mL. The platform can also be adapted for dose volumes of up to 0.75 mL, depending on the intended treatment application.
"Patients living with hypothyroidism deserve a treatment option that is both effective and precise in its delivery. Following a rigorous evaluation of available device solutions, D-Flex™ distinguished itself by consistently demonstrating the dose accuracy that our investigational XP-8121 demands. Its selection as our preferred device platform reflects our unwavering commitment to developing treatments that meet the highest standards of safety, reliability, and patient-centered care,” said Pete Valentinsson, Senior Vice President, Global Technical Operations at Xeris.
“Precise dose delivery is an important requirement for many next-generation therapies, particularly in the field of NTI drugs. We are proud to support Xeris and their development of XP-8121 with a device platform that has demonstrated outstanding dose accuracy and helps make these therapies available to patients,” said Dr. Oliver Haferbeck, Head of Business Unit Drug Delivery at medmix.
The collaboration reflects the growing demand for delivery devices capable of supporting increasingly complex therapies while meeting strict performance requirements. It further demonstrates the value of close collaboration between pharmaceutical and device companies in translating new therapeutic concepts into practical treatment options for patients. D-Flex™ has been marketed since 2023 and is supported by an established manufacturing and supply infrastructure. It is already deployed in an approved European product variant and an ongoing U.S. clinical program, resulting in limited device-related novelty and reduced development risk.
-Ends-
About medmix
medmix is a global leader in high-precision delivery devices, with leading positions in healthcare, consumer and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide together with our highly motivated and experienced team of nearly 2’700 employees are at service of our customers with uncompromising quality, proximity and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss
Inquiries:
Media Relations: communications@medmix.com
Investor Relations: investorrelations@medmix.com
This document may contain forward-looking statements including, but not limited to, projections of financial developments, market activity, or future performance of products and solutions containing risks and uncertainties. These forward-looking statements are subject to change based on known or unknown risks and various other factors that could cause actual results or performance to differ materially from the statements made herein.
medmix AG
Neuhofstrasse 20
CH-6430 Baar
communications@medmix.com
www.medmix.swiss
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FAQ
What is XP-8121 and what condition is it being developed to treat?
XP-8121 is an investigational once-weekly subcutaneous levothyroxine therapy that is being developed for the treatment of hypothyroidism. It uses a proprietary high-concentration XeriSol® levothyroxine formulation and is not yet an approved product.
Why is precise dose delivery especially important for XP-8121 and levothyroxine therapies?
Levothyroxine is classified by the U.S. Food and Drug Administration as a narrow therapeutic index (NTI) drug, meaning small differences in dose or blood concentration can lead to over- or undertreatment and adverse effects. The company states that accurate dose delivery and reliable device performance are therefore critical for the overall safety, efficacy, and reliability of levothyroxine drug-device combinations such as XP-8121.
What specific design features does the D-Flex™ pen platform offer to reduce dosing errors?
The D-Flex™ platform includes a patented dosing mechanism that allows patients to select only intended dose settings, so intermediate doses cannot be selected. This design helps reduce the potential for dosing errors while enabling multiple fixed-dose configurations and very small dose increments of down to 0.005 mL.
How widely established is the D-Flex™ platform in terms of manufacturing and current use?
D-Flex™ has been marketed since 2023 and is supported by an established manufacturing and supply infrastructure. It is already deployed in an approved European product variant and in an ongoing U.S. clinical program, which results in limited device-related novelty and reduced development risk for new combinations like XP-8121.