drugset
Drugs / PLX-200
last change Sep 2021 re-read 3 minutes ago

PLX-200

Developed for
juvenile neuronal ceroid lipofuscinosis
Investigated by
Polaryx Therapeutics, Inc.

Trials 1

today NCT04637282 · Ph 3
2027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT04637282 Nov → Dec 2026 expected juvenile neuronal ceroid lipofuscinosis Polaryx Therapeutics, Inc. Not yet recruiting No outcome recorded

Press releases naming this drug 8 releases

DateIssuerRelease
2021-09-02 Polaryx Therapeutics, Inc. Polaryx Therapeutics Receives FDA Orphan Drug Designation for PLX-200 to Treat Krabbe Disease polaryx.com ↗
2021-08-30 Polaryx Therapeutics, Inc. Polaryx Therapeutics Announces FDA Grants Orphan Drug Designation for PLX-200 in GM2 Gangliosidoses polaryx.com ↗
2020-08-20 Polaryx Therapeutics, Inc. Polaryx Therapeutics Receives FDA Fast Track Designation to PLX-200 for the Treatment of Patients With Juvenile Neuronal Ceroid Lipofuscinosis polaryx.com ↗
2020-04-08 Polaryx Therapeutics, Inc. Polaryx Therapeutics Receives IND Approval From the FDA to Study PLX-200 Treatment for Patients With Juvenile Neuronal Ceroid Lipofuscinosis polaryx.com ↗
2020-01-20 Polaryx Therapeutics, Inc. Polaryx Therapeutics Receives IND Approval for PLX-200 From the FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis polaryx.com ↗
2019-12-23 Polaryx Therapeutics, Inc. Polaryx Therapeutics Submits Investigational New Drug Application to the U.S. FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis With PLX-200 polaryx.com ↗
2018-02-26 Polaryx Therapeutics, Inc. Polaryx Therapeutics Received Orphan Drug Designation From the European Medicines Agency (EMA) for the Treatment of All Neuronal Ceroid Lipofuscinosis With PLX-200 polaryx.com ↗
2017-08-07 Polaryx Therapeutics, Inc. Polaryx Therapeutics Receives Orphan Drug Designation From the U.S. FDA for PLX-200 for Rare Pediatric Disease polaryx.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as PLX-200 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04637282 ↗
Route Oral “administered orally” NCT04637282 ↗