Drugs / CPP-115
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01493596 | Dec 2011 → Jun 2012 | cocaine dependence | Catalyst Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2016-09-19 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceuticals Announces Publication of CPP-115 Clinical Efficacy Data for Infantile Spasms in Epilepsy & Behavior Case Reports globenewswire.com ↗
The case report presents a child treated with CPP-115 through an investigational new drug protocol who experienced a significant reduction of seizures with no evidence of retinal dysfunction. |
| 2015-12-16 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceuticals Announces Top-Line Results in Phase 1(b) Trial of CPP-115 globenewswire.com ↗
The results showed significant increases in brain levels of the surrogate marker for potential efficacy, gamma-aminobutyric acid (GABA). |
| 2013-11-18 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Announces Publication of Preclinical Proof-of-Principle of CPP-115 Efficacy in Suppressing Infantile Spasms in Epilepsia globenewswire.com ↗ |
| 2012-05-22 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Reports Positive Results From Phase I(a) Clinical Study of CPP-115 globenewswire.com ↗
The study results demonstrated that CPP-115 was well tolerated at all six doses administered. |
| 2012-02-13 | Catalyst Pharmaceuticals, Inc. | Regulatory Catalyst Pharmaceutical Partners Granted Orphan Medicinal Product Designation in European Union for CPP-115 for the Treatment of West Syndrome (Infantile Spasms) globenewswire.com ↗
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that the European Commission (EC) has granted orphan medicinal product designation for the company's investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, for the treatment of West Syndrome (infantile spasms). |
| 2011-12-20 | Catalyst Pharmaceuticals, Inc. | Regulatory Catalyst Pharmaceutical Partners, Inc. Announces FDA Designation of CPP-115 as a Fast Track Development Program globenewswire.com ↗
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been designated as a Fast Track development program by the FDA for the treatment of cocaine dependency. |
| 2011-12-15 | Catalyst Pharmaceuticals, Inc. | Results Scientific Paper Regarding CPP-115 for the Treatment of Cocaine Addiction Accepted for Publication in the Journal of Medicinal Chemistry globenewswire.com ↗
CPP-115, Catalyst's novel GABA-AT inactivator, was evaluated and it was observed that CPP-115 does not exhibit other GABAergic or off-target activities and is rapidly and completely orally absorbed and eliminated. |
| 2011-12-02 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Announces Presentation to be Made at the American Epilepsy Society's 65th Annual Meeting globenewswire.com ↗
CPP-115, a new GABA transaminase inhibitor, suppresses infantile spasms in the rat multiple-hit model |
| 2011-08-31 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Announces Presentation of Data Regarding CPP-115 at the American Chemical Society Annual Fall Meeting globenewswire.com ↗
The data contained in Dr. Silverman's presentation is expected to be submitted for publication in a peer-reviewed journal in the future. |
| 2011-06-16 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Reports Positive Non-Clinical Efficacy Results Evaluating CPP-115 for the Treatment of Infantile Spasms globenewswire.com ↗
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced initial positive efficacy results from an investigator sponsored study of CPP-115 in an animal model of infantile spasms (IS). |
| 2010-11-01 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Reports Positive Non-Clinical Safety and Efficacy Results for CPP-115 globenewswire.com ↗
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced positive results from a series of CPP-115 preclinical safety and efficacy evaluations. |
| 2010-09-21 | Catalyst Pharmaceuticals, Inc. | Regulatory Catalyst Pharmaceutical Partners, Inc. Granted Orphan-Drug Designation for CPP-115 for the Treatment of Infantile Spasms globenewswire.com ↗
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been granted orphan-drug designation for the treatment of infantile spasms (West Syndrome) by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 18 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CPP-115 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01493596 ↗ |
| Modality | Small molecule | — CHEMBL146927 ↗ |
| Route | Oral | “CPP-115 Solution Administered Orally” NCT01493596 ↗ |