Drugs / GLM101
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GLM101

Developed for
PMM2-congenital disorder of glycosylation
Investigated by
Glycomine, Inc.

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT06657859 Sep 2024 → Sep 2029 expected PMM2-congenital disorder of glycosylation Glycomine, Inc. Enrolling by invitation No outcome recorded
Phase 2 NCT05549219 Nov 2022 → Nov 2025 PMM2-congenital disorder of glycosylation Glycomine, Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06892288 Jul 2025 → Sep 2026 overdue PMM2-congenital disorder of glycosylation Glycomine, Inc. Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2024-09-18 Glycomine, Inc. Regulatory Glycomine Receives FDA Fast Track Designation for GLM101 for the Treatment of PMM2-CDG glycomine.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLM101
2024-03-04 Glycomine, Inc. Results Glycomine Announces Encouraging Efficacy Data from Ongoing Phase 2 Clinical Study in PMM2-CDG glycomine.com ↗
The findings highlight the potential for clinically meaningful benefit with a notable improvement in the International Co-operative Ataxia Rating Scale (ICARS) score in four adult patients in the 30 mg/kg cohort, with an average improvement of 12 points after 12 weeks (n=4) of treatment.

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as GLM101 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05549219 ↗
2

NCT06892288 ↗

NCT06657859 ↗

Route Intravenous “GLM101 IV Infusion” NCT05549219 ↗