Drugs / Sialic Acid
Sialic Acid
also known as
Aceneuramic Acid · SA-ER · N-acetylneuraminic acid · Ace-ER · NANA · NSC-111756 · SA-ER tablets · SA-IR · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | polyglucosan body myopathy | 2015-10-02 | “successfully filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for aceneuramic acid prolonged release” ultragenyx.com ↗ |
Trials 7
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2017-08-22 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx Announces Top-Line Results from Phase 3 Study of Ace-ER in GNE Myopathy ultragenyx.com ↗ |
| 2016-11-11 | Ultragenyx Pharmaceutical Inc | Regulatory Ultragenyx Announces Withdrawal of Marketing Authorization Application for Aceneuramic Acid Prolonged Release (Ace-ER) in the European Union ultragenyx.com ↗
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that is has withdrawn its conditional Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for Aceneuramic Acid Prolonged Release (Ace-ER) for the treatment of adult patients with GNE Myopathy. |
| 2015-10-02 | Ultragenyx Pharmaceutical Inc | Regulatory Ultragenyx Announces Aceneuramic Acid Prolonged Release Marketing Authorization Application Filed and Accepted for Review by European Medicines Agency ultragenyx.com ↗
today announced it has successfully filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for aceneuramic acid prolonged release (Ace-ER; UX001) tablets intended for patients with GNE Myopathy. |
| 2014-10-13 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx Announces Interim Data From Phase 2 Extension Study of Sialic Acid Extended-Release at International Congress of the World Muscle Society ultragenyx.com ↗
The data from the extension study of SA-ER support our plans to move forward with this program, |
| 2013-12-20 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx Announces Results from Phase 2 Study of Sialic Acid Extended-Release Treatment in Hereditary Inclusion Body Myopathy ultragenyx.com ↗
Ultragenyx Announces Results from Phase 2 Study of Sialic Acid Extended-Release Treatment in Hereditary Inclusion Body Myopathy |
All press releases naming this drug 10 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sialic Acid | “Sialic Acid-Extended Release (SA-ER) Tablets” NCT01830972 ↗ |
| Known as | Ace-ER | “OBJECTIVE: To investigate the efficacy and safety of aceneuramic acid extended-release (Ace-ER), a treatment intended to replace deficient sialic acid, in patients with GNE myopathy.” PMID 31036580 ↗ Jan 2019 |
| Known as | Aceneuramic Acid | “The investigators will examine the efficacy and safety of aceneuramic acid (SA-ER tablets) 6g daily for 48 weeks in patients with GNE myopathy in a placebo-controlled,...” NCT04671472 ↗ |
| Known as | N-acetylneuraminic acid | “Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA).” NCT02845609 ↗1“NPC-09 tablet NPC-09 contains 50mg or 100mg N-acetylneuraminic acid (anhydride)” NCT01236898 ↗ |
| Known as | NANA | “Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA).” NCT02845609 ↗ |
| Known as | NSC-111756 | ChEMBL registry synonym — accepted as the source's own label CHEMBL152452 ↗ |
| Known as | SA-ER | “Participants were assigned to receive an extended-release formulation of aceneuramic acid (SA-ER) or placebo.” PMID 37568154 ↗ Aug 20232“Sialic Acid-Extended Release (SA-ER) Tablets” NCT01830972 ↗ “Sialic Acid Extended Release (SA-ER) Tablets” NCT01359319 ↗ |
| Known as | SA-ER tablets | “The investigators will examine the efficacy and safety of aceneuramic acid (SA-ER tablets) 6g daily for 48 weeks in patients with GNE myopathy in a placebo-controlled,...” NCT04671472 ↗ |
| Known as | SA-IR | “Sialic Acid-Immediate Release (SA-IR) Capsules” NCT01830972 ↗ |
| Known as | Sialic acids n-acetylneuraminic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL152452 ↗ |
| Known as | UX-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL152452 ↗ |
| Action | Restore | “effective replacement of the missing SA substrate” NCT01359319 ↗ |
| Modality | Small molecule | — CHEMBL152452 ↗ |
| Route | Oral | “oral administration of N-acetylneuraminic acid” NCT01236898 ↗ |