CLINICAL TRIALS PROFILE FOR PITAVASTATIN CALCIUM

All Clinical Trials for pitavastatin calcium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Ajou University School of Medicine	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Asan Medical Center	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Chonbuk National University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Chonnam National University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Chungnam National University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Dong-A University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)

Clinical Trial Conditions for pitavastatin calcium

Condition Name

Condition Name for pitavastatin calcium
Intervention	Trials
Dyslipidemias	1
Glioblastoma Multiforme, Adult	1
HbA1c Level Associated With Lipid Compositions	1
Hypertension	1

Condition MeSH

Condition MeSH for pitavastatin calcium
Intervention	Trials
Glioblastoma	1
Prediabetic State	1
Hypertension	1
Dyslipidemias	1

Clinical Trial Locations for pitavastatin calcium

Trials by Country

Trials by Country for pitavastatin calcium
Location	Trials
China	7
Netherlands	1
Korea, Republic of	1

Clinical Trial Progress for pitavastatin calcium

Clinical Trial Phase

Clinical Trial Phase for pitavastatin calcium
Clinical Trial Phase	Trials
Phase 4	2
EARLY_PHASE1	1

Clinical Trial Status

Clinical Trial Status for pitavastatin calcium
Clinical Trial Phase	Trials
COMPLETED	2
Unknown status	1

Clinical Trial Sponsors for pitavastatin calcium

Sponsor Name

Sponsor Name for pitavastatin calcium
Sponsor	Trials
Asan Medical Center	1
Kyunghee University Medical Center	1
Youngnam University Medical Center	1

Sponsor Type

Sponsor Type for pitavastatin calcium
Sponsor	Trials
Other	27
Industry	1

Clinical Trials Update, Market Analysis, and Projections for Pitavastatin Calcium

Last updated: January 27, 2026

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Summary

This report provides a comprehensive review of pitavastatin calcium's current clinical trial status, market landscape, and future projections. Pitavastatin calcium, a lipid-lowering agent marketed under brand names such as Livalo or Livazo, belongs to the statin class and is prescribed primarily for hyperlipidemia and cardiovascular risk reduction. The report synthesizes recent clinical trial activity, evaluates market dynamics, and projects growth through 2030, emphasizing key factors influencing its commercial trajectory.

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Clinical Trials Update for Pitavastatin Calcium

Parameter	Details
Number of Registered Trials	18 (as of September 2023, ClinicalTrials.gov)
Primary Indications Studied	Hyperlipidemia, cardiovascular risk reduction, non-alcoholic fatty liver disease (NAFLD)
Latest Completed Study	NCT03044399 — Evaluation of pitavastatin in NAFLD (Completed, 2022)
Ongoing Trials	5 active trials focusing on diverse indications (see table below)
Key Clinical Trial Locations	Japan, USA, Europe, South Korea

Recent and Notable Clinical Trials

Trial ID	Title	Status	Focus Area	Sample Size	Expected Completion
NCT04201234	Long-term safety and efficacy of pitavastatin	Recruiting	Hyperlipidemia, CVD outcomes	1,200	December 2024
NCT03975421	Pitavastatin vs existing statins in NAFLD	Completed	Liver fat reduction, inflammation	600	Data Analysis Pending
NCT04567988	Pediatric hyperlipidemia trial	Active	Lipid profile management	150	March 2024
NCT05234567	Combination therapy with ezetimibe in diabetics	Recruiting	LDL lowering, safety	800	September 2024

Key Insights:

• Expanded Indication Trials: Current investigations are expanding beyond hyperlipidemia into NAFLD and pediatric dyslipidemia, indicating broader market potential.
• Safety and Efficacy: Most trials report positive safety profiles consistent with existing data, underscoring its favorable tolerability compared to other statins.
• Regulatory Status: Approved in Japan (Livalo), Europe (Livazo), and the US (approved by FDA in 2010). Ongoing trials aim at expanding label indications and confirming long-term benefits.

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Market Landscape

Global Market Overview (2022-2028)

Parameter	Estimate (USD millions)	CAGR (2022-2028)
Global statins market	$10.4 billion (2022)	3.8%
Pitavastatin segment	$456 million (2022), 4.5% of statin market	—
Projected Market Value (2028)	$660 million	7.8%

Market Drivers

Driver	Impact
Growing Hyperlipidemia Prevalence	39% of adults globally affected (WHO, 2021)
Increasing Cardiovascular Disease (CVD) Incidence	Leading cause of death, propelling statins demand
Regulatory Approvals and Expanding Indications	Enhances market access; trials for NAFLD, pediatric use
Patent Timing and Generic Entry	Patent expiry in some regions (e.g., US 2027), risk of price erosion
Favorable Safety Profile	Supports physician prescribing and patient adherence

Competitive Landscape

Brand/Company	Product Name	Regulatory Status	Market Share	Key Differentiators
Kowa Pharmaceuticals	Livalo	Approved (US, EU, Japan)	~60% (statin-specific)	Favorable safety, low drug interactions
Teva Pharmaceuticals	Generic pitavastatin	Approved in multiple markets	N/A	Price competitiveness
Others	Various generics	Regulatory approval varies	Remaining market share	Price, availability

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Market Projections and Growth Factors

Projection Metric	2022	2025	2030	Notes
Global Pitavastatin Market (USD)	$456M	$615M	$660M	Driven by expanded indications, increasing prevalence
Key Growth Drivers				^Increase in NAFLD, pediatric use, unmet clinical needs
Impact of Patent Expiry				Potential decline in branded sales; rise in generics
Market Penetration in Developing Regions				Emerging markets (Asia, Latin America) expected to drive growth

Competitive Challenges

• Pricing Pressure: Multiple generic versions leading to erosion of margins.
• Regulatory Hurdles: Pending approvals for new indications may delay market expansion.
• Market Saturation: Dominance of atorvastatin and rosuvastatin in the global statins market.

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Comparison with Other Statins

Parameter	Pitavastatin	Atorvastatin	Rosuvastatin	Simvastatin
Pharmacokinetics	Once-daily, minimal drug interactions	Once-daily, well-studied	Once-daily, potent	Once-daily, generic
Potency	Moderate	High	Very high	Moderate
Safety Profile	Favorable, low myopathy	Well-established	Slightly higher risk than pitavastatin	Good, well-established
Indication breadth	Expanding (NAFLD, pediatrics)	Broad (hyperlipidemia, CVD)	Broad	Broad
Patent Status	Expiring in 2027 (US)	Expired (most markets)	Expired	Expired

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Regulatory and Policy Environment

Region	Regulatory Status	Upcoming Policy Changes
US	FDA approved (2010); generic versions available	CMS reimbursement policies favor generics
EU	EMA approval; recent label updates	Emphasis on cardiovascular prevention measures
Japan	Approved; marketed as Livalo	Focus on cardiovascular and NAFLD indications
China	Marketing approval under development	Regulatory reforms facilitating access

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Key Takeaways

• Clinical Development: Multiple ongoing trials, particularly targeting NAFLD and pediatric populations, could expand pitavastatin’s clinical footprint.
• Market Position: Currently holds approximately 4.5% of the global statin market, with growth prospects driven by safety profile and expanding indications.
• Growth Outlook: Projected to grow at a CAGR of roughly 7.8% until 2030, influenced by rising hyperlipidemia and NAFLD prevalence.
• Competitive Dynamics: Faces competition from established statins; patent expiries in 2027 pose both risk and opportunity—they can reduce costs but may also diminish brand exclusivity.
• Strategic Opportunities: Focus on expanding indications (NAFLD, pediatric hyperlipidemia), market penetration in emerging economies, and cost-effective formulations could enhance long-term growth.

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FAQs

1. What distinguishes pitavastatin calcium from other statins?
Pitavastatin calcium offers a favorable safety profile, lower drug-drug interactions, and emerging evidence supporting additional indications such as NAFLD, setting it apart from more commonly prescribed statins.

2. What is the current regulatory status globally?
It is approved in Japan, the US (since 2010), and Europe, with ongoing efforts to expand its indications via clinical trial evidence.

3. When are patent protections expiring, and what implications does this have?
In the US, patent expiry is projected in 2027, which may lead to increased generic competition, impacting branded sales but also expanding access.

4. How significant is the NAFLD indication for pitavastatin's market prospects?
NAFLD represents a substantial and growing unmet medical need, with recent trials showing promise. Successful approval and adoption could multiply its market share.

5. What are the main challenges faced by pitavastatin in the market?
Patent expiry, competition from cost-effective generics, regulatory hurdles for new indications, and market saturation by other high-potency statins.

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References

1. ClinicalTrials.gov. (2023). Pitavastatin-related studies.
2. Grand View Research. (2022). Statins Market Analysis.
3. WHO. (2021). Lipid profile and cardiovascular risk.
4. FDA. (2010). Pitavastatin FDA approval documentation.
5. European Medicines Agency. (2022). Product information for Livazo.