Investigational Drug Information for Parsaclisib

What is the drug development status for Parsaclisib?

Parsaclisib is an investigational drug.

There have been 33 clinical trials for Parsaclisib. The most recent clinical trial was a Phase 2 trial, which was initiated on September 1^st 2025.

The most common disease conditions in clinical trials are Lymphoma, Lymphoma, Follicular, and Primary Myelofibrosis. The leading clinical trial sponsors are Incyte Corporation, Innovent Biologics (Suzhou) Co. Ltd., and Incyte Biosciences Japan GK.

There are ninety-four US patents protecting this investigational drug and two hundred and ninety-five international patents.

Summary for Parsaclisib

US Patents	94
International Patents	295
US Patent Applications	278
WIPO Patent Applications	146
Japanese Patent Applications	14
Clinical Trial Progress	Phase 2 (2025-09-01)
Vendors	38

Recent Clinical Trials for Parsaclisib

Title	Sponsor	Phase
Linperlisib in the Treatment of aPRCA	Peking Union Medical College Hospital	PHASE2
Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma	Innovent Biologics (Suzhou) Co. Ltd.	Phase 1
Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL	Fudan University	Phase 1/Phase 2

See all Parsaclisib clinical trials

Clinical Trial Summary for Parsaclisib

Top disease conditions for Parsaclisib

Top clinical trial sponsors for Parsaclisib

See all Parsaclisib clinical trials

US Patents for Parsaclisib

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Parsaclisib		Bicyclic fused pyrimidine compounds as TAM inhibitors	Incyte Corporation (Wilmington, DE)
Parsaclisib		Pyrrolopyrimidine derivatives as TAM inhibitors	Incyte Corporation (Wilmington, DE)
Parsaclisib		Treatment of B-cell malignancies by a combination JAK and PI3K inhibitors	Incyte Corporation (Wilmington, DE)
Parsaclisib		Heterocyclic compounds as PI3K-.gamma. inhibitors	Incyte Corporation (Wilmington, DE)
Parsaclisib		Heterocyclylamines as PI3K inhibitors	Incyte Corp , Incyte Holdings Corp
Parsaclisib		Salts of a Pim kinase inhibitor	Incyte Corporation (Wilmington, DE)
Parsaclisib		Salts and processes of preparing a PI3K inhibitor	Incyte Corporation (Wilmington, DE)

International Patents for Parsaclisib

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
Parsaclisib	World Intellectual Property Organization (WIPO)	WO2017027717	2035-08-12
Parsaclisib	World Intellectual Property Organization (WIPO)	WO2017035366	2035-08-26
Parsaclisib	Australia	AU2015244044	2034-04-08
Parsaclisib	Australia	AU2020213313	2034-04-08
Parsaclisib	Australia	AU2022206693	2034-04-08
Parsaclisib	Brazil	BR112016023322	2034-04-08
Parsaclisib	Brazil	BR122021024771	2034-04-08

Parsaclisib Market Analysis and Financial Projection

Last updated: February 13, 2026

Development Status of Parsaclisib

Parsaclisib, a selective PI3Kδ inhibitor developed by AbbVie, remains in advanced clinical development. Initially authorized for hematologic cancers, particularly follicular lymphoma and marginal zone lymphoma, its broader indications include other B-cell malignancies.

Current Clinical Trials and Approvals

• Phase III Trials: The drug is evaluated in multiple Phase III studies, primarily for follicular lymphoma and marginal zone lymphoma. Notably:

  • CITADEL-504 (NCT04270709): Focuses on relapsed or refractory follicular lymphoma.
  • SEAL (NCT03530249): Examines efficacy in relapsed or refractory marginal zone lymphoma.

• Regulatory Status:

  • In March 2021, the FDA granted Breakthrough Therapy Designation for Parsaclisib in follicular lymphoma.
  • As of late 2022, the drug has not received full approval; regulatory review continues or is pending based on ongoing data submission.

Development Challenges

• Safety concerns related to immune suppression and infections.
• Competitive landscape with other PI3K inhibitors like idelalisib, copanlisib, and duvelisib.
• Clinical efficacy demonstrated is promising but specific data on durability of response and long-term safety remains incomplete.

Market Projection Analysis

Market Size and Growth Drivers

• Hematologic Cancers Market: Driven by increasing incidence of B-cell lymphomas globally.
• Current Market Value: Estimated at $1.2 billion in 2022, with a compound annual growth rate (CAGR) projected at approximately 8% through 2030.

Competitive Dynamics

• Key Competitors:

  • Idelalisib (Gilead): Marketed for CLL and follicular lymphoma.
  • Copanlisib (Bayer): Approved for follicular lymphoma.
  • Duvelisib (Fresenius Kabi): Approved for CLL and follicular lymphoma.

• Differentiators for Parsaclisib:

  • Selectivity for PI3Kδ may reduce off-target effects.
  • Oral administration convenience.
  • Ongoing trials aim to establish superior efficacy or safety profiles.

Market Entry Outlook

• Potential Launch Timeline: If regulatory approval is granted in 2023/2024, commercial launch could occur by 2024 or 2025.
• Market Penetration Expectations:
  • Initial adoption in refractory or relapsed cases.
  • Expansion into frontline settings depends on upcoming trial results.

Regulatory and Commercial Risks

• Delays in approval or rejection based on safety concerns.
• Competing products with established market shares.
• Cost considerations influencing patient access and reimbursement.

Summary of Key Data Points

Aspect	Details
Current development phase	Phase III ongoing
Pending regulatory decisions	FDA review ongoing
Indications	Follicular lymphoma, marginal zone lymphoma
Major competitors	Idelalisib, copanlisib, duvelisib
Market size (2022)	$1.2 billion
Predicted CAGR (2022-2030)	8%

Key Takeaways

• Parsaclisib's clinical development continues, with regulatory submissions pending.
• Safety profile remains a concern, influencing market potential.
• The hematologic malignancies market presents growth opportunities, contingent on approval outcomes and competitive positioning.
• The drug's market entry could significantly impact the PI3K inhibitor segment if safety and efficacy data are favorable.

FAQs

1. What are the primary indications for Parsaclisib?
   Follicular lymphoma and marginal zone lymphoma.

2. When is Parsaclisib expected to receive regulatory approval?
   Potential approval could occur in 2023 or 2024, depending on submitted data and regulatory review.

3. What are the main competitors to Parsaclisib?
   Idelalisib, copanlisib, and duvelisib.

4. What factors could impede its market growth?
   Safety concerns, competitive products, and delays in approval.

5. How might the market for Parsaclisib evolve if approved?
   It could secure a significant share in relapsed/refractory B-cell lymphoma treatment, especially if it offers improved safety or efficacy over existing options.