ZYPITAMAG (pitavastatin magnesium)
** Zypitamag is an HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in
How ZYPITAMAG Works
This drug works by blocking HMG-CoA reductase, the enzyme responsible for the rate-limiting step in the body's cholesterol production pathway. By inhibiting this enzyme, the medication triggers the liver to increase its expression of LDL-receptors, which then pull more cholesterol out of the bloodstream. This process effectively lowers plasma total cholesterol and reduces the production of very low density lipoproteins.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-07-14
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
ZYPITAMAG Approval History
What ZYPITAMAG Treats
1 indicationsZYPITAMAG is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperlipidemia
ZYPITAMAG Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ZYPITAMAG
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06982131 | BP45800 2024-519277-18-00 | Ph 1 | recruiting | A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants |
| NCT07567781 | M25-744 | Ph 1 | recruiting | A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. |
| NCT07549958 | STUDY00000701 UCI 24-105 | Ph 1 | recruiting | PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC) |
| NCT06808646 results posted | BPR-CP-101 HHSO100201600002C, 2024-518592-60-00 | Ph 1 | completed | A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin |
| NCT06813924 | NN7535-7976 U1111-1309-3456 | Ph 1 | completed | A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants |
| NCT04512105 | 20205930 CDMRP-CA190644, UCI 18-128 | Ph 1 | completed | Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia |
| NCT02344290 REPRIEVE results posted | A5332 11960, 1U01HL123339-01 | Ph 3 | completed | Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults |
| NCT02888327 | AL-794-802 | Ph 1 | completed | A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872 |
| NCT05537948 PINTL | 2.0_17.03.22 | Ph 4 | active not recruiting | Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients |
| NCT03070223 PREPARE results posted | ACTG A5361s UM1AI068636, R01AG054366 | Ph 3 | completed | PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332) |
| NCT02956590 DO IT! | PHN DO IT! | Ph 3 | completed | Dyslipidemia of Obesity Intervention in Teens |
| NCT06359353 | B-1902-520-004 | Ph 4 | completed | Effect of Pitavastatin on Bone |
| NCT04643093 | OP-1PC111-301 | Ph 3 | completed | Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
| NCT01166633 PITCH | CWP-PTV-707 | Ph 4 | completed | Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia |
| NCT02863185 | Pita_2016 | Ph 4 | completed | Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease |
| NCT01695954 results posted | 11-01787 | Ph 1 | completed | Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz |
| NCT03717064 results posted | YP40218 | Ph 1 | completed | A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers |
| NCT00889226 ESPRIT results posted | CWP_PTV4_704 | Ph 4 | completed | Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia |
| NCT02743260 | PHENTRA_2015_KPUK | Ph 4 | completed | Drug Transporter Interaction Study PHENTRA_2015_KPUK |
| NCT02144922 EPOCH | 2013-1091 | Ph 4 | completed | Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients |
| NCT02442700 results posted | Ramathibodi Hospital 01-57-18 | Ph 4 | completed | Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir |
| NCT02595268 | CR107446 63623872FLZ1004, 2015-000628-27 | Ph 1 | completed | A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants |
| NCT00701285 SAPHIRE | CWP-PTV-703 | Ph 4 | completed | South Korean Pitavastatin Heart Failure Study |
| NCT01301066 results posted | NK-104-4.05US | Ph 4 | completed | A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects |
| NCT00861861 COMPACT-CAD | Kumamoto-746 | Ph 4 | completed | Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD) |
| NCT01595828 CAPITAIN | NK-104-4.03EU | Ph 1 | completed | Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome |
| NCT01256476 PREVAIL-US results posted | NK-104-4.04US | Ph 4 | completed | Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia |
| NCT00786734 | CWP-PTV-705 | Ph 4 | withdrawn | Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA) |
| NCT00640276 ProPit | CWP_PTV_706 | Ph 4 | completed | Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYPITAMAG FDA Label Details
Indications & Usage
FDA Label (PDF)ZYPITAMAG is indicated for the treatment of Hyperlipidemia.
ZYPITAMAG Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ZYPITAMAG
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 9 active patents
Trial Analysis
- • 29 total trials
- • Stage: Mature
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment