Drugs / lomitapide
lomitapide
also known as
AEGR-733 · BMS201038 · Aegr-733 mesilate · AEGR-733 MESYLATE · BMS-201038-01 · BMS-201038-04 · Juxtapid · Lojuxta · +3 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | JUXTAPID | — | 2026-02-25 | fda.gov ↗ |
| Approved | EU (EMA) | Lojuxta | — | 2013-07-31 | europa.eu ↗ |
| Approved | US (FDA) | JUXTAPID | — | 2012-12-21 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02080468 | Feb → Apr 2014 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02080455 | Jan → Mar 2014 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02044419 | Oct → Dec 2013 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01915771 | Jul → Aug 2013 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01760187 | Nov 2012 → Jun 2013 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT00474240 | Apr 2007 → Oct 2008 | hyperlipidemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00405067 | May 2006 → Jan 2007 | hyperlipidemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00359281 | Mar 2006 → Nov 2007 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01556906 | Jun 2003 → Feb 2004 | homozygous familial hypercholesterolemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT04681170 | Dec 2020 → Oct 2022 | homozygous familial hypercholesterolemia | Amryt Pharma | Completed | Met primary |
| Phase 3 | NCT02765841 | May 2016 → Mar 2017 | homozygous familial hypercholesterolemia | Aegerion Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02173158 | Apr 2014 → Apr 2015 | homozygous familial hypercholesterolemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00943306 | Oct 2009 → Sep 2012 | homozygous familial hypercholesterolemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00730236 | Dec 2007 → Sep 2010 | homozygous familial hypercholesterolemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT00690443 Comparator | May → Sep 2008 | hyperlipidemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00559962 Comparator | Oct 2007 → Oct 2008 | hyperlipidemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | Chiesi Farmaceutici S.p.A. | Chiesi Global Rare Diseases Announces European Commission Approval of LOJUXTA® (lomitapide) ▼ Capsules for Paediatric Use in Homozygous Familial Hypercholesterolaemia (HoFH) chiesi.com ↗ |
| 2026-04-01 | Chiesi Farmaceutici S.p.A. | Chiesi Global Rare Diseases receives positive CHMP opinion for LOJUXTA® (lomitapide) ▼ Capsules for pediatric use in Homozygous Familial Hypercholesterolemia (HoFH) chiesi.com ↗ |
| 2019-02-06 | RECORDATI GROUP | RECORDATI OBTAINS EXCLUSIVE LICENSE FOR JUXTAPID® IN JAPAN, recordati.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lomitapide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01556906 ↗ |
| Known as | AEGR-733 | “study medication AEGR-733 at 10 or 60 mg” NCT00359281 ↗ |
| Known as | Aegr-733 mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | AEGR-733 MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | BMS-201038-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | BMS-201038-04 | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | BMS201038 | “A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 (Formerly BMS201038) and Atorvastatin 20...” NCT00474240 ↗ |
| Known as | Juxtapid | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | Lojuxta | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | Lomitapida | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | Lomitapide mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Known as | LOMITAPIDE MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL354541 ↗ |
| Action | Inhibit | “MTP-Inhibitor AEGR-733” NCT00559962 ↗ |
| Modality | Small molecule | — CHEMBL354541 ↗ |
| Route | Oral | “take an oral dose of AEGR-733 at 10 mg or 60 mg” NCT00359281 ↗ |