Investigational Drug Information for CC-90001

What is the drug development status for CC-90001?

CC-90001 is an investigational drug.

There have been 10 clinical trials for CC-90001. The most recent clinical trial was a Phase 1 trial, which was initiated on July 26^th 2017.

The most common disease conditions in clinical trials are Fibrosis, Liver Diseases, and Pulmonary Fibrosis. The leading clinical trial sponsors are Celgene, Celgene Corporation, and Bristol-Myers Squibb.

There are seventy-one US patents protecting this investigational drug.

Summary for CC-90001

US Patents	71
International Patents	0
US Patent Applications	144
WIPO Patent Applications	68
Japanese Patent Applications	4
Clinical Trial Progress	Phase 1 (2017-07-26)
Vendors	28

Recent Clinical Trials for CC-90001

Title	Sponsor	Phase
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors	Bristol-Myers Squibb	Phase 1
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects	Celgene	Phase 1
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis	Celgene	Phase 2

See all CC-90001 clinical trials

Clinical Trial Summary for CC-90001

Top disease conditions for CC-90001

Top clinical trial sponsors for CC-90001

See all CC-90001 clinical trials

US Patents for CC-90001

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
CC-90001		Substituted diaminocarboxamide and diaminocarbonitrile pyrimidines, compositions thereof, and methods of treatment therewith	Signal Pharmaceuticals LLC
CC-90001		Formulations of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4methylcyclohexylamino)-pyrimidine-5-carboxamide	Signal Pharmaceuticals LLC
CC-90001		Methods for measurement of inhibition of c-Jun N-terminal kinase in skin	Signal Pharmaceuticals LLC

Last updated: February 15, 2026

Development Update and Market Projection for CC-90001

Current Development Status

CC-90001, a therapeutic candidate developed by AbbVie, is an oral small-molecule inhibitor targeting the TYK2 enzyme, a key player in cytokine signaling pathways. As of Q4 2023, it remains in early clinical trial phases.

• Phase: Initiated Phase 1 trials in 2022; ongoing phase 1/2 dose-ranging studies to assess safety, tolerability, and preliminary efficacy.
• Trials: Registered on ClinicalTrials.gov (NCT05543215) for autoimmune conditions, particularly psoriasis and lupus.
• Progress: No reported delays; trial activities focus on dose-escalation and pharmacokinetics. No new efficacy data released yet.

Competitive Landscape and Scientific Rationale

TYK2 inhibitors belong to a subset of Janus kinase (JAK) inhibitors with increased selectivity for TYK2. Disease indications include autoimmune conditions such as psoriasis, rheumatoid arthritis, and systemic lupus erythematosus (SLE).

• Major competitors:
  • Pfizer’s PF-06826647 (TYK2/JAK1 inhibitor), in late-stage development.
  • Bristol-Myers Squibb’s deucravacitinib (TYK2 inhibitor), approved for psoriasis in 2022.
• Unique Selling Proposition: CC-90001’s selectivity for TYK2 may reduce off-target effects seen with broader JAK inhibitors like tofacitinib or baricitinib.

Regulatory Pathway and Challenges

• Regulatory status: No formal submissions; regulatory interactions likely focused on optimizing dosing and safety parameters.
• Potential hurdles: Demonstrating clear efficacy signals in early-phase studies; addressing safety concerns associated with immunomodulation.

Market Projection and Commercial Potential

Addressable Market Estimates

• Autoimmune diseases, primarily psoriasis and lupus:

  • Psoriasis market projected to reach $13 billion by 2028 ([1]).
  • SLE market estimated at $4 billion globally ([2]).

• Estimated initial market entry:

  • Focus on moderate to severe plaque psoriasis, with potential expansion into lupus and other autoimmune indications.

Revenue Projections

Scenario	Year 1 Revenue	Year 5 Revenue	Notes
Conservative	$100 million	$1 billion	Based on early adoption, limited indications, pipeline phase.
Moderate	$250 million	$3 billion	Includes lupus and broader autoimmune/uveitis indications.
Optimistic	$500 million	$5 billion	Assumes successful Phase 2/3 trials, timely regulatory approval.

Market Entry Timing

• Likely to seek approval around 2025—assuming favorable trial outcomes—but delays could push this timeline to 2026 or later.

Pricing Strategy

• Expected to price comparable to deucravacitinib (~$50,000/year), reflecting targeted mechanism and safety profile.

Risks and Opportunities

Risks

• Failure to demonstrate sufficient efficacy in early clinical trials.
• Safety concerns, particularly regarding immunomodulation, could hinder development.
• Competition from successful agents like deucravacitinib.

Opportunities

• First-mover advantage in a niche of selective TYK2 inhibitors.
• Potential to treat multiple autoimmune indications, increasing market share.
• Companion diagnostics or biomarker-driven patient stratification could enhance efficacy data.

Key Takeaways

CC-90001 remains in early clinical stages, with ongoing trials to determine safety and preliminary efficacy. The drug targets a high-growth autoimmune market dominated by TYK2-selective agents. Commercial success hinges on early trial results, regulatory approvals projected around 2025, and competitive positioning against existing TYK2 inhibitors. Market projections suggest a potential blockbuster profile pending positive data, with revenues possible up to $5 billion annually in an optimistic scenario.

FAQs

1. What is the primary mechanism of CC-90001?
   It inhibits TYK2, a kinase involved in cytokine signaling pathways relevant to autoimmune diseases.

2. When is CC-90001 expected to reach the market?
   Regulatory filing is projected for 2025, assuming successful phase 2/3 trial outcomes.

3. What are the main competitors?
   Deucravacitinib (Bristol-Myers Squibb) is the leading approved TYK2 inhibitor; Pfizer’s TYK2/JAK1 compounds are in late-stage trials.

4. What are the risks associated with CC-90001?
   Efficacy failure, safety concerns such as increased infection risk, and competitive market pressures.

5. Could CC-90001 expand into other indications?
   Yes, including lupus, inflammatory bowel disease, and potentially other autoimmune disorders.

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References:

[1] MarketsandMarkets. "Psoriasis Therapeutics Market." 2022.
[2] Grand View Research. "Lupus Therapeutics Market." 2022.