Investigational Drug Information for IPI-549

What is the development status for investigational drug IPI-549?

IPI-549 is an investigational drug.

There have been 5 clinical trials for IPI-549. The most recent clinical trial was a Phase 1 trial, which was initiated on March 6^th 2020.

The most common disease conditions in clinical trials are Triple Negative Breast Neoplasms, Carcinoma, and Head and Neck Neoplasms. The leading clinical trial sponsors are Infinity Pharmaceuticals, Inc., Bristol-Myers Squibb, and Arcus Biosciences, Inc.

There are one hundred and eighty-three US patents protecting this investigational drug and three hundred and forty-nine international patents.

Summary for IPI-549

US Patents	183
International Patents	349
US Patent Applications	469
WIPO Patent Applications	203
Japanese Patent Applications	22
Clinical Trial Progress	Phase 1 (2020-03-06)
Vendors	52

Recent Clinical Trials for IPI-549

Title	Sponsor	Phase
Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma	The V Foundation for Cancer Research	Phase 2
Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma	Ezra Cohen	Phase 2
Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma (MARIO-3)	Roche Pharma AG	Phase 2

See all IPI-549 clinical trials

Clinical Trial Summary for IPI-549

Top disease conditions for IPI-549

Top clinical trial sponsors for IPI-549

See all IPI-549 clinical trials

US Patents for IPI-549

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
IPI-549		Bicyclic fused pyrimidine compounds as TAM inhibitors	Incyte Corporation (Wilmington, DE)
IPI-549		Pyrrolopyrimidine derivatives as TAM inhibitors	Incyte Corporation (Wilmington, DE)
IPI-549		Solid forms of isoquinolinones, and process of making, composition comprising, and methods of using the same	Infinity Pharmaceuticals, Inc. (Cambridge, MA)
IPI-549		Crystalline forms of tenofovir alafenamide	GILEAD SCIENCES, INC. (Foster City, CA)
IPI-549		Tank-binding kinase inhibitor compounds	Gilead Sciences, Inc. (Foster City, CA)
IPI-549		Substituted pyrrolizine compounds and uses thereof	GILEAD SCIENCES, INC. (Foster City, CA)
IPI-549		Heterocyclic compounds and uses thereof	Infinity Pharmaceuticals, Inc. (Cambridge, MA)

International Patents for IPI-549

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
IPI-549	World Intellectual Property Organization (WIPO)	WO2017027717	2035-08-12
IPI-549	World Intellectual Property Organization (WIPO)	WO2017035366	2035-08-26
IPI-549	Australia	AU2016322552	2035-09-14
IPI-549	Canada	CA2998469	2035-09-14
IPI-549	China	CN108349985	2035-09-14
IPI-549	China	CN114230571	2035-09-14
IPI-549	European Patent Office	EP3350183	2035-09-14

IPI-549 Development Update and Market Projection

Last updated: February 20, 2026

What is the current status of IPI-549 development?

IPI-549, also known as duvastat, is a selective phosphoinositide 3-kinase gamma (PI3Kγ) inhibitor developed by Infinity Pharmaceuticals. It is primarily evaluated as an immuno-oncology agent targeting tumor-associated macrophages (TAMs).

• Phase: Completed Phase 1 safety and tolerability trials.
• Indications: Under investigation for certain cancers, including non-small cell lung cancer (NSCLC) and melanoma.
• Recent Data: Phase 1b expansion cohorts show manageable safety profile and signs of clinical activity, such as partial responses and stable disease in some patients (Infinity Pharmaceuticals, 2022).
• Trials: Current focus on combination therapies with immune checkpoint inhibitors like pembrolizumab.

What are primary clinical and regulatory milestones?

• 2020: Phase 1 trial completed; data supported further development.
• 2021: Initiation of Phase 1b/2 studies evaluating IPI-549 with PD-1 inhibitors.
• 2022: Early signals of efficacy in combination studies; ongoing recruitment.
• Next milestones: Data readouts expected from ongoing trials in 2023-2024, potentially affecting partnership or licensing negotiations.

What are the competitive landscape and market size?

Competitive landscape

Drug Candidate	Target	Development Stage	Company	Indications
IPI-549	PI3Kγ	Phase 1b/2	Infinity	Melanoma, NSCLC
IPI-549 + pembrolizumab	Combination	Ongoing	Infinity	Multiple solid tumors
Johns Hopkins' PI3Kγ inhibitor	PI3Kγ	Preclinical	Johns Hopkins	Cancer
Cabiralizumab	CSF1R	Phase 2	Moderna	Solid tumors, pancreatic cancer

Market size projection

• The global immuno-oncology market reached USD 19.7 billion in 2021 and is expected to grow at a CAGR of 12.4% over the next five years (Fortune Business Insights, 2022).
• PI3K pathway inhibitors currently represent a USD 7 billion segment, mainly due to PI3Kδ and PI3Kα inhibitors; PI3Kγ inhibitors are emerging.
• Estimated market for PI3Kγ inhibitors as monotherapy or in combination: USD 0.8 billion by 2027, driven by unmet needs in resistant cancers and combination strategies.

What is the outlook for market adoption?

• The development of IPI-549 aligns with increasing interest in TAM modulation for cancer immunotherapy.
• Combination therapies with PD-1/PD-L1 inhibitors are standard, expanding potential indications.
• Efficacy signals in early trials may accelerate registration pathways, especially if biomarker-driven response patterns are confirmed.

What factors influence future success?

• Ability to demonstrate significant clinical benefits over existing treatments.
• Successful management of adverse effects.
• Regulatory acceptance of combination therapy data.
• Competitive landscape and emergence of alternative PI3Kγ inhibitors.

Key Takeaways

• IPI-549 has completed Phase 1 and is in early combination trials, showing promising safety and activity signals.
• The drug targets TAMs through PI3Kγ inhibition, fitting into the expanding immuno-oncology market.
• Market projections indicate a USD 0.8 billion opportunity by 2027, emphasizing the importance of clinical data and regulatory progress.
• Competitive landscape involves other early-stage PI3Kγ inhibitors and combination strategies.

FAQs

1. What are the main challenges facing IPI-549 development?

Overcoming resistance, demonstrating statistically significant clinical outcomes, managing side effects, and establishing clear combination protocols.

2. How does IPI-549 compare to other PI3K inhibitors?

It selectively targets PI3Kγ, focusing on immune modulation rather than direct tumor cell inhibition, potentially offering fewer side effects than pan-PI3K inhibitors.

3. What are the key regulatory hurdles?

Gaining approval for combination therapies involves navigating complex trial designs and demonstrating additive or synergistic effects with existing treatments.

4. When are pivotal data expected?

Potential interim data from ongoing Phase 1b/2 trials could be available in 2023-2024, influencing invest and partnership decisions.

5. Which indications are most likely to drive initial market entry?

Melanoma and NSCLC, where immune checkpoint inhibitors are standard and TAM modulation could improve outcomes.

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References

1. Infinity Pharmaceuticals. (2022). IPI-549 Clinical Trial Updates. Retrieved from https://www.infinitypharma.com
2. Fortune Business Insights. (2022). Immuno-oncology Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com