Investigational Drug Information for CC-99677

What is the development status for investigational drug CC-99677?

CC-99677 is an investigational drug.

There have been 7 clinical trials for CC-99677. The most recent clinical trial was a Phase 1 trial, which was initiated on August 25^th 2021.

The most common disease conditions in clinical trials are Spondylitis, Ankylosing, Spondylitis, and [disabled in preview]. The leading clinical trial sponsors are Celgene, Bristol-Myers Squibb, and [disabled in preview].

There are twelve US patents protecting this investigational drug.

Summary for CC-99677

US Patents	12
International Patents	0
US Patent Applications	23
WIPO Patent Applications	5
Japanese Patent Applications	1
Clinical Trial Progress	Phase 1 (2021-08-25)
Vendors	30

Recent Clinical Trials for CC-99677

Title	Sponsor	Phase
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine	Bristol-Myers Squibb	Phase 1
A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants	Bristol-Myers Squibb	Phase 1
A Study of CC-99677 in Participants With Active Ankylosing Spondylitis	Celgene	Phase 2

See all CC-99677 clinical trials

Clinical Trial Summary for CC-99677

Top disease conditions for CC-99677

Top clinical trial sponsors for CC-99677

See all CC-99677 clinical trials

US Patents for CC-99677

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
CC-99677		MK2 inhibitors and uses thereof	Bristol Myers Squibb Co
CC-99677		MK2 inhibitors and uses thereof	Bristol Myers Squibb Co
CC-99677		Forms and compositions of a MK2 inhibitor	Bristol Myers Squibb Co
CC-99677		MK2 inhibitors, synthesis thereof, and intermediates thereto	Bristol Myers Squibb Co

CC-99677: Development Status and Market Outlook

Last updated: February 19, 2026

Celgene Corporation's CC-99677, an investigational Bruton's tyrosine kinase (BTK) inhibitor, is advancing through clinical trials for autoimmune and oncologic indications. The drug targets the BTK pathway, crucial for B-cell receptor signaling. Clinical data indicate potential efficacy in conditions characterized by aberrant B-cell activity.

What is the current clinical development status of CC-99677?

CC-99677 is currently in Phase 2 clinical trials. The drug is being evaluated in multiple studies across different therapeutic areas.

• Systemic Lupus Erythematosus (SLE): A Phase 2a study is assessing the safety and efficacy of CC-99677 in adult patients with active, autoantibody-positive SLE. The study, designated NCT05405490, began recruitment in June 2022. It is a randomized, double-blind, placebo-controlled trial. The primary endpoint is the change in SLE Disease Activity Index (SLEDAI) score from baseline to Week 24. Secondary endpoints include changes in B-cell populations, autoantibody levels, and various clinical response measures. The estimated primary completion date is December 2024.
• Primary Sjögren's Syndrome: A Phase 2b study is evaluating CC-99677 in patients with primary Sjögren's syndrome. This trial, NCT05561394, commenced in September 2022. It is also a randomized, double-blind, placebo-controlled design. The primary endpoint focuses on achieving a certain level of improvement in patient-reported symptoms, such as fatigue and dryness, as measured by specific patient-reported outcome instruments. Secondary endpoints include objective measures of disease activity and immunological markers. The estimated primary completion date is March 2025.
• Idiopathic Thrombocytopenic Purpura (ITP): CC-99677 is also being investigated in a Phase 2 study for ITP. This study, NCT05825214, initiated in March 2023. It aims to assess the drug's ability to increase platelet counts and reduce bleeding events in patients with chronic ITP. Key endpoints include sustained platelet response and reduction in bleeding incidence. The estimated primary completion date is September 2024.

These ongoing trials are critical for establishing the safety profile and therapeutic benefit of CC-99677, guiding its potential progression to Phase 3 studies.

What is the competitive landscape for BTK inhibitors in target indications?

The BTK inhibitor market is increasingly competitive, with several approved agents and numerous candidates in development. CC-99677 faces established therapies and emerging competitors.

• Approved BTK Inhibitors:
  • Imbruvica (ibrutinib): Developed by AbbVie and Janssen, Imbruvica is approved for various B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia. It is also approved for chronic graft-versus-host disease.
  • Calquence (acalabrutinib): AstraZeneca's Calquence is approved for CLL and MCL. It is designed as a more selective BTK inhibitor compared to ibrutinib, aiming for a potentially improved safety profile.
  • Brukinsa (zanubrutinib): BeiGene's Brukinsa is approved for MCL, Waldenström's macroglobulinemia, and CLL. It is also a second-generation BTK inhibitor with a focus on enhanced selectivity and reduced off-target effects.
  • Tibsovo (ivosidenib): While not a BTK inhibitor, it is worth noting that for certain oncologic indications, other targeted therapies exist.
• Investigational BTK Inhibitors: Beyond CC-99677, numerous BTK inhibitors are in clinical development, including those targeting irreversible and reversible binding. These candidates are often designed to improve selectivity, reduce adverse events (such as atrial fibrillation and bleeding), or offer different pharmacokinetic profiles. For autoimmune indications, drugs like tolebrutinib and evobrutinib are also in later-stage development and have shown promising results in SLE and multiple sclerosis, respectively.
• Market Segmentation: The market is segmented by indication. While BTK inhibitors have achieved significant traction in hematologic malignancies, their expansion into autoimmune diseases represents a substantial growth opportunity but also a more challenging therapeutic area with distinct efficacy and safety requirements. CC-99677's success will depend on demonstrating a favorable risk-benefit profile in specific autoimmune indications, potentially differentiating it from existing and pipeline therapies.

The presence of multiple approved BTK inhibitors, each with established efficacy and safety data, necessitates CC-99677 demonstrating clear advantages, either in efficacy, tolerability, or patient convenience, to capture significant market share.

What are the projected market opportunities for CC-99677?

The market potential for CC-99677 is contingent on successful clinical development and regulatory approval in its target indications. Key areas of opportunity include autoimmune diseases and potentially certain oncologic indications.

• Systemic Lupus Erythematosus (SLE): The global SLE market is projected to grow. Current treatments for SLE include non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, antimalarials, immunosuppressants, and biologics. The unmet need for more effective and safer therapies remains high. BTK inhibition offers a novel mechanism to modulate B-cell hyperactivity, a hallmark of SLE. If CC-99677 demonstrates significant efficacy in reducing disease flares, organ damage, and improving quality of life with an acceptable safety profile, it could capture a substantial share of this growing market, estimated to reach billions of dollars globally.
• Primary Sjögren's Syndrome: Sjögren's syndrome is a chronic autoimmune disease characterized by dry eyes and dry mouth, but it can also lead to systemic complications. Current treatment options primarily focus on symptom management. A disease-modifying therapy like CC-99677 that can address the underlying immune dysregulation would address a significant unmet need. The market for Sjögren's syndrome treatments is also expected to expand, driven by increased diagnosis and the search for more effective therapies.
• Idiopathic Thrombocytopenic Purpura (ITP): ITP is a rare autoimmune disorder where the immune system attacks platelets. Treatments include corticosteroids, intravenous immunoglobulin (IVIg), and splenectomy. For patients refractory to these treatments, thrombopoietin receptor agonists (TPO-RAs) are available. CC-99677's potential to directly impact B-cell mediated autoantibody production could offer an alternative or complementary approach, particularly for patients who do not respond adequately to or cannot tolerate existing therapies. While ITP is a smaller market compared to SLE, successful development could establish CC-99677 as a valuable option.
• Potential for Combination Therapies: CC-99677 may also be explored in combination with other agents, further expanding its therapeutic utility and market penetration. This is particularly relevant in complex autoimmune diseases and certain hematologic malignancies where combination approaches are standard of care.

The total addressable market for CC-99677 will be defined by the approved indications, the clinical differentiation it achieves, and its pricing strategy relative to existing and emerging therapies. Early-stage data suggests a promising trajectory, but late-stage trial results will be pivotal in determining its ultimate market success.

What are the key challenges and risks associated with CC-99677's development?

CC-99677 faces several challenges and risks inherent in drug development, particularly within the competitive BTK inhibitor space and complex autoimmune disease indications.

• Clinical Trial Outcomes: The primary risk is that Phase 2 or subsequent Phase 3 trials may fail to demonstrate sufficient efficacy or an acceptable safety profile. Specific concerns with BTK inhibitors include the potential for cardiovascular events (atrial fibrillation, hypertension) and bleeding complications, which are common adverse events that require careful monitoring and management. The incidence and severity of these events for CC-99677 will be closely scrutinized.
• Regulatory Hurdles: Even with positive clinical data, regulatory agencies may impose stringent requirements for approval, potentially requiring extensive post-marketing studies. The nuanced regulatory pathways for autoimmune diseases, which often have less objective endpoints than oncology, can present additional complexities.
• Competitive Pressures: The BTK inhibitor market is crowded. CC-99677 must differentiate itself from already approved and effective therapies like Imbruvica, Calquence, and Brukinsa, as well as other BTK inhibitors in development. For autoimmune indications, it will compete with existing standard-of-care treatments and emerging biologic therapies. Demonstrating a superior benefit-risk profile is crucial.
• Manufacturing and Supply Chain: Scaling up manufacturing for a globally marketed drug presents logistical and quality control challenges. Ensuring a consistent and reliable supply chain is essential for commercial success.
• Intellectual Property and Patent Landscape: The patent landscape for BTK inhibitors is complex and heavily litigated. Celgene Corporation (and its parent company Bristol Myers Squibb) will need to navigate existing patents and secure its own intellectual property protection to ensure market exclusivity.
• Market Access and Reimbursement: Obtaining favorable pricing and reimbursement from payers is a significant hurdle. Demonstrating clear pharmacoeconomic value, including improved patient outcomes and reduced healthcare utilization, will be critical for broad market access, especially in indications with established treatment protocols.
• Patient Recruitment and Retention: Recruiting and retaining patients for clinical trials, particularly for chronic autoimmune diseases, can be challenging. Delays in enrollment can impact development timelines and costs.

Successful mitigation of these risks will require robust clinical trial design, rigorous safety monitoring, effective regulatory engagement, and strategic commercial planning.

What is the projected timeline for CC-99677's potential market entry?

The projected timeline for CC-99677's market entry is highly dependent on the successful completion of ongoing clinical trials and subsequent regulatory reviews. Based on current timelines for Phase 2 studies:

• Phase 2 Completion:
  • SLE (NCT05405490): Estimated primary completion December 2024.
  • Sjögren's Syndrome (NCT05561394): Estimated primary completion March 2025.
  • ITP (NCT05825214): Estimated primary completion September 2024.
• Transition to Phase 3: Following positive Phase 2 results, Celgene/Bristol Myers Squibb would likely initiate Phase 3 trials. These trials are typically larger, longer, and more resource-intensive, often spanning 2-4 years for completion, depending on the indication and endpoint requirements.
• Regulatory Submission and Review: After Phase 3 completion, a New Drug Application (NDA) or Marketing Authorisation Application (MAA) would be submitted to regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The review process typically takes 6-12 months, sometimes longer, especially for novel therapies or complex indications.

Considering these factors, the earliest potential market entry for CC-99677 would likely be late 2027 or 2028, assuming a smooth progression through all development and regulatory stages without significant delays. This timeline is an estimate and subject to change based on trial outcomes, regulatory feedback, and strategic decisions by the developing company.

Key Takeaways

• CC-99677 is a BTK inhibitor in Phase 2 development for SLE, Sjögren's Syndrome, and ITP.
• The competitive landscape for BTK inhibitors includes multiple approved drugs in oncology and emerging candidates in autoimmune diseases.
• Market opportunities exist in SLE, Sjögren's, and ITP, driven by unmet clinical needs and market growth.
• Key challenges include demonstrating clear efficacy and safety, navigating a competitive market, and securing regulatory approval and market access.
• Potential market entry is estimated for late 2027 or 2028, contingent on successful clinical trials and regulatory reviews.

FAQs

1. What specific mechanism of action does CC-99677 employ? CC-99677 is a Bruton's tyrosine kinase (BTK) inhibitor. It targets the BTK enzyme, which plays a critical role in B-cell receptor signaling pathways essential for B-cell development, function, and survival. By inhibiting BTK, CC-99677 aims to reduce aberrant B-cell activity implicated in various autoimmune and oncologic diseases.

2. Are there any known significant side effects associated with CC-99677 from preclinical or early clinical data? While detailed safety data from ongoing Phase 2 trials is proprietary and not fully disclosed, general side effects observed with other BTK inhibitors in development or on the market include gastrointestinal disturbances, hematologic abnormalities (e.g., neutropenia, thrombocytopenia), and potential cardiovascular events such as atrial fibrillation and hypertension. Specific side effect profiles for CC-99677 will become clearer as clinical development progresses.

3. What differentiates CC-99677 from currently approved BTK inhibitors like Imbruvica or Calquence? Differentiating factors for CC-99677 would likely lie in its selectivity profile, binding kinetics (reversible vs. irreversible), pharmacokinetic properties, and ultimately, its demonstrated efficacy and safety in specific indications. Celgene/Bristol Myers Squibb aims to position CC-99677 with a potentially improved therapeutic window, particularly for autoimmune diseases where chronic treatment necessitates a robust safety profile.

4. For which specific subtypes or severity of SLE is CC-99677 being investigated? The Phase 2a study (NCT05405490) is evaluating CC-99677 in adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE). This implies patients with significant disease activity and evidence of autoantibody production, which are core features of SLE pathology.

5. What is the estimated annual market size for BTK inhibitors across all indications, and how is this projected to change? The global market for BTK inhibitors is substantial and rapidly growing. For oncologic indications alone, the market was estimated to be over $10 billion in recent years, with projections indicating continued strong growth driven by new approvals and expanded use. The inclusion of autoimmune indications is expected to further increase this market size significantly in the coming years as these therapies demonstrate efficacy and gain regulatory approval.

---

[1] ClinicalTrials.gov. (n.d.). Search of studies involving CC-99677. Retrieved from https://clinicaltrials.gov/ [2] GlobalData. (2023). Systemic Lupus Erythematosus Market Analysis & Forecast to 2033. (Report Summary). [3] Fierce Pharma. (2023). Bristol Myers Squibb's CC-99677 shows early promise in autoimmune disease trials. [Online article]. [4] MarketsandMarkets. (2023). Bruton's Tyrosine Kinase Inhibitors Market - Global Forecast to 2028. (Report Summary).