Drugs / Sarizotan
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00314288 | Jul 2002 → Jul 2003 | Parkinson disease, drug-induced dyskinesia | EMD Serono | Completed | No outcome recorded |
| Phase 2 | NCT00009048 | Jan 2001 → Dec 2003 | Parkinson disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT02790034 | Oct 2016 → Aug 2019 | Rett syndrome | Newron Pharmaceuticals SPA | Terminated | Missed primary |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT00105521 | Sep 2004 → Mar 2006 | Parkinson disease, movement disorder | EMD Serono | Completed | No outcome recorded |
| Phase 3 | NCT00105508 | Sep 2004 → Feb 2006 | Parkinson disease, drug-induced dyskinesia | EMD Serono | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT00310661 | Dec 2004 → Sep 2006 | tardive dyskinesia | Centre for Addiction and Mental Health | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2020-05-04 | Newron Pharmaceuticals SPA | Results Newron Reports Top-Line Results from its STARS Study Evaluating Sarizotan in Patients with Rett Syndrome newron.com ↗
Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced today that top-line results from its STARS clinical study evaluating sarizotan in patients with Rett syndrome did not demonstrate evidence of efficacy on the primary or secondary efficacy variables. |
| 2019-11-19 | Newron Pharmaceuticals SPA | Regulatory Newron Receives FDA Rare Pediatric Disease Designation for Sarizotan for the Treatment of Rett Syndrome newron.com ↗
The decision of the FDA to designate sarizotan for the treatment of a rare pediatric population |
| 2018-10-31 | Newron Pharmaceuticals SPA | Results Newron Pharmaceuticals hosts its 2018 R&D Day in New York City newron.com ↗
The STARS base line data from more than 100 patients suggest that up to 70 percent of patients experience clinical significant apnea and minimally 3/5 10 percent of their time is spent without breathing. |
| 2017-05-17 | Newron Pharmaceuticals SPA | Regulatory Newron Pharmaceuticals Announces Expansion of STARS Study to Include Patients Under 13 Years of Age newron.com ↗
An amendment to allow the inclusion of the patients under the age of 13 was approved by the FDA after Newron submitted results from juvenile toxicology studies. |
| 2016-05-17 | Newron Pharmaceuticals SPA | Regulatory Newron Announces IND Approval for Sarizotan for Treatment of Rett Syndrome newron.com ↗
Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced today that its Investigational New Drug (IND) application for the evaluation of sarizotan for the treatment of patients with Rett syndrome was approved by the U.S. Food and Drug Administration (FDA). |
| 2015-07-14 | Newron Pharmaceuticals SPA | Regulatory Newron Receives FDA Orphan Drug Designation for Sarizotan for the Treatment of Rett Syndrome newron.com ↗
today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Newron’s New Chemical Entity (NCE) sarizotan for treatment of Rett syndrome. |
| 2015-06-25 | Newron Pharmaceuticals SPA | Regulatory Newron receives positive opinion for ODD for Sarizotan to treat patients with Rett Syndrome from EMA’s COMP newron.com ↗ |
All press releases naming this drug 9 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sarizotan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00105521 ↗ |
| Known as | EMD 128130 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00009048 ↗ |
| Known as | EMD-77697 | ChEMBL registry synonym — accepted as the source's own label CHEMBL220808 ↗ |
| Known as | Sarizotan hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL220808 ↗ |
| Known as | SARIZOTAN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL220808 ↗ |
| Action | Activate | “a selective agonist of serotonin 5-HT1A receptors” NCT00009048 ↗4“Serotonin 1a (5-HT1a) receptor agonist” CHEMBL220808 ↗ “Dopamine D2 receptor partial agonist” CHEMBL220808 ↗ “Dopamine D3 receptor agonist” CHEMBL220808 ↗ “Dopamine D4 receptor agonist” CHEMBL220808 ↗ |
| Modality | Small molecule | — CHEMBL220808 ↗ |
| Route | Oral | “patients will begin taking either EMD 128130 tablets or capsules or a placebo” NCT00009048 ↗ |
| Target | DRD2 | “Dopamine D2 receptor partial agonist” CHEMBL220808 ↗ |
| Target | DRD3 | “Dopamine D3 receptor agonist” CHEMBL220808 ↗ |
| Target | DRD4 | “Dopamine D4 receptor agonist” CHEMBL220808 ↗ |
| Target | HTR1A | “Serotonin 1a (5-HT1a) receptor agonist” CHEMBL220808 ↗ |