Juxtapid

(Lomitapide)

Phase 3Small molecule

Chiesi Farmaceutici S.p.A.

Juxtapid is one of 56 small molecule programs targeting Atherosclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

AtherosclerosisActive, not recruiting

Homozygous Familial HypercholesterolemiaActive, not recruiting

AtherosclerosisPreclinical

Active, not recruiting

Homozygous Familial HypercholesterolemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

165 competitors in Atherosclerosis

#DrugCompanyPhaseTrials

Avandia

Alnylam Pharmaceuticals

Phase 3

3 2

Estrace

Novo Nordisk

Phase 3

2 3

Depo-Provera

Pfizer

Phase 3

2 4

Colcrys

Alnylam Pharmaceuticals

Phase 3

1 5

Glucotrol

Pfizer

Phase 3

1 6

Actemra

Roche

Phase 3

1 7

Brilinta

AstraZeneca

Phase 3

1 8

Ilaris

Novartis

Phase 3

—9

Benicar

CCosette Pharmaceuticals, Inc.

Phase 3

2 10

Altoprev

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Recruiting

GIST

NCT02135705

Clinical

Trials by Indication[1]

Homozygous Familial Hypercholesterolemia2 trials

Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy

Withdrawn·AAegerion Pharmaceuticals, Inc.·Phase 3·NCT02765841

Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia

Completed·AAegerion Pharmaceuticals, Inc.·Phase 3·NCT00943306·19 enrolled

Hypercholesterolaemia1 trial

Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)

Completed·AAmryt Pharma·Phase 3·NCT04681170·46 enrolled

MPA1 trial

A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

Completed·AAegerion Pharmaceuticals, Inc.·Phase 1·NCT02044419·32 enrolled

Atorvastatin1 trial

Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.

Completed·AAegerion Pharmaceuticals, Inc.·Phase 1·NCT02080455·32 enrolled

Pregnancy1 trial

Global Lomitapide Pregnancy Exposure Registry

Terminated·AAmryt Pharma··NCT02399839·5 enrolled

7 more indications

Atherosclerosis1 trial

Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Withdrawn·AAegerion Pharmaceuticals, Inc.··NCT02399852

Tics1 trial

Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects

Completed·AAegerion Pharmaceuticals, Inc.·Phase 1·NCT01915771·15 enrolled

TED1 trial

Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C

Completed·AAegerion Pharmaceuticals, Inc.·Phase 1·NCT01760187·72 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy

Completed·AAegerion Pharmaceuticals, Inc.·Phase 3·NCT02173158·9 enrolled

Efficacy1 trial

Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor

Completed·AAegerion Pharmaceuticals, Inc.·Phase 2·NCT01556906·6 enrolled

GIST1 trial

LOWER: Lomitapide Observational Worldwide Evaluation Registry

Recruiting·AAmryt Pharma··NCT02135705·300 enrolled

Female1 trial

Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

Completed·AAegerion Pharmaceuticals, Inc.·Phase 1·NCT02080468·32 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 25, 2026

JUXTAPID

NDA NDA203858

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Lomitapide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lomitapide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lomitapide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203858). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Juxtapid. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Chiesi Farmaceutici S.p.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Chiesi Farmaceutici S.p.A.

Patent Landscape[5]

Patent Cliff

Aug 19, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7932268Aug 19, 2027

12472172Jul 29, 2041

Juxtapid

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Homozygous Familial Hypercholesterolemia2 trials

Hypercholesterolaemia1 trial

MPA1 trial

Atorvastatin1 trial

Pregnancy1 trial

Atherosclerosis1 trial

Tics1 trial

TED1 trial

Efficacy and Safety1 trial

Efficacy1 trial

GIST1 trial

Female1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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