Biogen Advances New SKYCLARYS Formulation in Early Trial, Supporting Long-Term Rare Disease Strategy

Biogen Inc. (BIIB) announced an update on their ongoing clinical study.

Study Overview
This Phase 1 Biogen study, officially titled “A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants,” aims to see whether a new tablet-for-suspension form of BIIB141 (omaveloxolone/SKYCLARYS) behaves in the body the same way as the current capsule. The focus is on how the drug is absorbed and processed in healthy adults, and on basic safety signals. The work matters because an easier-to-take form could broaden use in Friedreich’s ataxia and support longer-term revenue durability for Biogen.

Intervention/Treatment
The study tests omaveloxolone (BIIB141), an oral drug already approved for Friedreich’s ataxia. Participants receive the same medicine in two ways: as a standard capsule and as a tablet dissolved in liquid (tablet for oral suspension). The new liquid-ready form is intended to help patients who have trouble swallowing capsules, improving convenience and adherence.

Study Design
This is an interventional, Phase 1, randomized, open-label, two-period crossover study in healthy volunteers. All participants receive both forms of the drug in different orders, with a washout period between doses. There is no placebo and no blinding. The main purpose is treatment-focused bioequivalence: to compare how much drug gets into the bloodstream and how fast, and to confirm that both forms perform similarly while monitoring basic safety and tolerability.

Study Timeline
The study is listed as recruiting, with startup activities initiated in December 2025. Participants are screened for up to 28 days and then remain in the research unit for around 30 days, with total participation of up to 57 days. Key readouts will follow the “primary completion” date, when all participants finish dosing and main measurements; the “study completion” date will come later, after all data checks and analyses are done. The record was most recently updated on 7 January 2026, signaling that the trial plan and status have been reviewed and confirmed on ClinicalTrials.gov.

Market Implications
For investors, this update supports Biogen’s strategy to enhance the value of its rare disease portfolio through life-cycle management rather than new efficacy claims. Bioequivalence success would allow Biogen to offer a more flexible SKYCLARYS formulation without repeating large efficacy trials, potentially strengthening its competitive position in Friedreich’s ataxia and supporting steady, if niche, revenue. While this single early-phase study is unlikely to move BIIB’s share price on its own, it reinforces the company’s execution in rare neurological diseases against emerging competitors in genetic and RNA-based therapies. Clarity around bioequivalent formulations can also help protect pricing, reduce switching risk, and support physician confidence over time.

The study is currently ongoing and updated, with full details available on the ClinicalTrials.gov portal under NCT07297199.

To learn more about BIIB’s potential, visit the Biogen Inc. drug pipeline page.