Drugs / fenofibric acid
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FIBRICOR | — | 2009-08-14 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02422030 | Mar 2015 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01964365 | Sep → Dec 2013 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT00719693 | Jul → Sep 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00960570 | Feb → Mar 2008 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00960856 | Nov 2007 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00812955 | Nov 2008 → Jun 2009 | hyperlipidemia | AstraZeneca | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT01974297 | Jul 2013 → Jun 2014 | hyperlipidemia, combined, 2 | Sang Hak Lee | Unknown | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT01501435 Comparator | Dec 2011 → Apr 2012 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01472380 Comparator | Nov → Dec 2011 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01356290 Background | Apr 2014 → Apr 2030 expected | atypical teratoid rhabdoid tumor, ependymoma, medulloblastoma | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 3 | NCT00973271 Comparator | Mar → Nov 2011 | hypertriglyceridemia | Essentialis, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT00300430 Comparator | Sep 2006 → Mar 2008 | coronary artery disorder, hyperlipidemia, combined, 2 | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00300482 Comparator | Mar → Dec 2006 | coronary artery disorder, hyperlipidemia, combined, 2 | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00300456 Comparator | Mar 2006 → Mar 2007 | coronary artery disorder, hyperlipidemia, combined, 2 | Abbott | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2010-03-30 | AstraZeneca | Regulatory AstraZeneca and Abbott receive FDA complete response letter on CERTRIAD new drug application astrazeneca.com ↗
Tuesday, 30 March 2010 AstraZeneca and Abbott announced today that the US Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD (rosuvastatin/fenofibric acid delayed release) Capsules. |
| 2009-06-04 | AstraZeneca | Regulatory AstraZeneca and Abbott Submit New Drug Application to the FDA for the Approval of CERTRIAD for the Treatment of Mixed Dyslipidemia astrazeneca.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-07-15 | Impax Laboratories, LLC | Impax Laboratories Launches Authorized Generic TRILIPIX® Delayed Release Capsules, 45 mg and 135 mg amneal.com ↗ |
| 2010-03-30 | AstraZeneca | AstraZeneca and Abbott receive FDA complete response letter on CERTRIAD new drug application astrazeneca.com ↗ |
| 2009-06-04 | AstraZeneca | AstraZeneca and Abbott Submit New Drug Application to the FDA for the Approval of CERTRIAD for the Treatment of Mixed Dyslipidemia astrazeneca.com ↗ |
| 2009-06-04 | AstraZeneca | AstraZeneca and Abbott Extend Relationship to Include Co-Promotion of Trilipix astrazeneca.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fenofibric acid | “Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme.” PMID 18783301 ↗ 200812“ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks” NCT00812955 ↗ “To evaluate a new formulation of fenofibric acid (ABT-335)” PMID 18996523 ↗ Oct 2008 “Fenofibric acid 135mg” NCT02422030 ↗ |
| Known as | ABT-335 | “Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme.” PMID 18783301 ↗ 20082“This multicenter, double-blind, active-controlled study evaluated ABT-335 (fenofibric acid) in combination with” PMID 19195513 ↗ Dec 2008 “To evaluate a new formulation of fenofibric acid (ABT-335)” PMID 18996523 ↗ Oct 2008 |
| Known as | Trilipix | “INTERVENTION: Fenofibric acid (Trilipix) 135 mg monotherapy” PMID 20136164 ↗ 20101“Fenofibric (Trilipix) acid” NCT02422030 ↗ |
| Action | Inhibit | “Fenofibric Acid is an inhibitor of CYP 2B6.” NCT00960570 ↗ |
| Modality | Small molecule | “fibric acid derivative (fibrate)” PMID 18783301 ↗ 2008 |
| Route | Oral | “On Days 22 through 30, all subjects will receive a single oral dose of fenofibric acid (1 x 105 mg tablet) in the morning without regard to meals.” NCT00960570 ↗ |
| Target | CYP2B6 | “Fenofibric Acid is an inhibitor of CYP 2B6.” NCT00960570 ↗ |