Pitavastatin: clinical trials recruiting now
3
Recruiting trials
7
Conditions studied
1
US states with sites
3
Countries
FDA drug label
- FDA-approved
- Yes. Pitavastatin appears in the FDA drug-label database. Marketed as Pitavastatin Calcium.
FDA-approved use
Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Impurity/Degradation Specifications — AvKARE | Class III (FDA: unlikely to cause harm) | Ongoing | 2025-06-26 |
| Failed Impurities/Degradation Specifications. — Orient Pharma Co., Ltd. Yunlin Plant | Class III (FDA: unlikely to cause harm) | Ongoing | 2025-06-11 |
| Presence of foreign tablets/capsules — Kowa Pharmaceuticals America | Class III (FDA: unlikely to cause harm) | Completed | 2025-02-24 |
| Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg — Annora Pharma Private Limited | Class III (FDA: unlikely to cause harm) | Ongoing | 2026-02-03 |
| Failed Impurity/Degradation Specifications — AvKARE | Class III (FDA: unlikely to cause harm) | Ongoing | 2025-06-26 |
Phase breakdown
Phase 1 3
Conditions being studied
| Condition | Trials |
|---|---|
| Dyslipidaemia | 1 |
| NASH | 1 |
| Non-alcoholic Fatty Liver Disease (NAFLD) | 1 |
| Obesity | 1 |
| Overweight | 1 |
| Pancreatic Cancer | 1 |
| Pancreatic Cancer Metastatic | 1 |
Recruiting trials involving Pitavastatin
- 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
- PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)
- Study of ECC4703 With Sulfasalazine and Pitavastatin
Common questions
Is Pitavastatin FDA-approved?
Yes, marketed as Pitavastatin Calcium.
How many recruiting trials involve Pitavastatin?
3 recruiting trials across 7 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.