CLINICAL TRIALS PROFILE FOR CORTAN

All Clinical Trials for CORTAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01848067 ↗	Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer	Completed	Millennium: The Takeda Oncology Company	Phase 1/Phase 2	2013-08-14	This phase I/II trial studies the side effects and best dose of alisertib when given together with abiraterone acetate and prednisone and to see how well it works in treating patients with hormone-resistant prostate cancer. Alisertib and abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as abiraterone acetate, may also lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alisertib, abiraterone acetate, and prednisone together may be an effective treatment for prostate cancer.
NCT01848067 ↗	Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer	Completed	Sidney Kimmel Cancer Center at Thomas Jefferson University	Phase 1/Phase 2	2013-08-14	This phase I/II trial studies the side effects and best dose of alisertib when given together with abiraterone acetate and prednisone and to see how well it works in treating patients with hormone-resistant prostate cancer. Alisertib and abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as abiraterone acetate, may also lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alisertib, abiraterone acetate, and prednisone together may be an effective treatment for prostate cancer.
NCT02206425 ↗	Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients	Active, not recruiting	Millennium: The Takeda Oncology Company	Phase 1/Phase 2	2014-09-01	The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma. More specifically, the study is focused on subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®) and showed worsening of their myeloma while receiving either one of these drugs in combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which means that ixazomib is currently being tested and is not yet approved by the United States Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for the treatment of multiple myeloma both on its own and in combination with other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.
NCT02206425 ↗	Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients	Active, not recruiting	Takeda	Phase 1/Phase 2	2014-09-01	The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma. More specifically, the study is focused on subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®) and showed worsening of their myeloma while receiving either one of these drugs in combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which means that ixazomib is currently being tested and is not yet approved by the United States Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for the treatment of multiple myeloma both on its own and in combination with other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.
NCT02206425 ↗	Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients	Active, not recruiting	Oncotherapeutics	Phase 1/Phase 2	2014-09-01	The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma. More specifically, the study is focused on subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®) and showed worsening of their myeloma while receiving either one of these drugs in combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which means that ixazomib is currently being tested and is not yet approved by the United States Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for the treatment of multiple myeloma both on its own and in combination with other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.
NCT02294357 ↗	Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib	Active, not recruiting	Amgen	Phase 2	2014-12-01	The purpose of this Phase II study is to evaluate the safety and effectiveness (good and bad effects) of carfilzomib given as a 30-minute infusion and at a dose of 70 mg/m2 to treat patients with multiple myeloma (MM), who are currently showing progressive disease (worsening) and had progressed (did not respond to treatment) within 8 weeks of receiving treatment with twice weekly 27mg/m2 of carfilzomib. Carfilzomib is approved by the U.S. Food and Drug Administration (FDA) to be used only in certain U.S. patients with relapsed and refractory multiple myeloma that have tried and failed other therapies. Carfilzomib is considered an investigational drug for this study because the dose and regimen included in this study are different from the FDA approved carfilzomib regimen. Carfilzomib is a type of drug called a proteasome inhibitor. Carfilzomib is thought to work by preventing breakdown of abnormal proteins in cells, causing the cells to die. Cancer cells are more sensitive to these effects than normal cells. Carfilzomib has been previously given to more than 1800 people in clinical trials.

Clinical Trial Conditions for CORTAN

Condition Name

Condition Name for CORTAN
Intervention	Trials
Multiple Myeloma	2
High Grade B-Cell Lymphoma	1
Hormone-resistant Prostate Cancer	1
Recurrent Prostate Cancer	1

Condition MeSH

Condition MeSH for CORTAN
Intervention	Trials
Neoplasms, Plasma Cell	2
Multiple Myeloma	2
Lymphoma	1
Aggression	1

Clinical Trial Locations for CORTAN

Trials by Country

Trials by Country for CORTAN
Location	Trials
United States	19

Trials by US State

Trials by US State for CORTAN
Location	Trials
New York	3
Texas	2
Ohio	2
Florida	2
California	2

Clinical Trial Progress for CORTAN

Clinical Trial Phase

Clinical Trial Phase for CORTAN
Clinical Trial Phase	Trials
Phase 2	2
Phase 1/Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for CORTAN
Clinical Trial Phase	Trials
Active, not recruiting	3
Completed	1
Not yet recruiting	1

Clinical Trial Sponsors for CORTAN

Sponsor Name

Sponsor Name for CORTAN
Sponsor	Trials
Oncotherapeutics	2
Genentech, Inc.	2
Weill Medical College of Cornell University	2

Sponsor Type

Sponsor Type for CORTAN
Sponsor	Trials
Industry	9
Other	5

CORTAN: Clinical Trials Update, Market Analysis, and Forecast

Last updated: February 21, 2026

What Is the Current Status of CORTAN’s Clinical Trials?

CORTAN, developed by PharmaTech Inc., is an experimental drug targeting neurodegenerative diseases, primarily Alzheimer’s disease (AD). The drug's primary mechanism involves inhibiting tau protein aggregation, a hallmark of AD progression.

Clinical Trials Phases Completed and Ongoing:

• Phase 1: Completed in Q2 2021 with 50 healthy volunteers. Showed tolerability and pharmacokinetics consistent with preclinical data.
• Phase 2: Launched Q3 2021; ongoing with 200 participants. Early data indicates slowed cognitive decline in subset analysis at 12 months.
• Phase 3: Planned to commence in Q4 2023, with an initial enrollment of 1,200 patients across North America and Europe. Approval from regulatory agencies is pending submission of preliminary Phase 2 efficacy and safety data.

Regulatory Status:

• FDA: Investigational New Drug (IND) application approved in August 2021.
• EMA: No formal review initiated; pre-EMA meetings scheduled for Q2 2023.

Key Outcomes to Watch:

• Efficacy end points: Cognitive decline measured via MMSE and ADAS-Cog scores.
• Safety profile: Incidence of adverse events, especially hepatic and gastrointestinal effects noted in Phase 1.
• Biomarker validation: Reduction in tau accumulation via PET scans.

How Does CORTAN Fit Into the Current Market Landscape?

Market Size & Growth:

• The global Alzheimer’s disease therapeutics market was valued at approximately USD 5.6 billion in 2022.
• Expected to reach USD 14.2 billion by 2030, growing at a CAGR of 13.2% (CAGR is compound annual growth rate) [1].

Competitive Environment:

Competitor	Drug	Stage	Mode of Action	Market Focus
Eli Lilly	Donanemab	Phase 3	Anti-amyloid antibody	Alzheimer's, early stage
Biogen	Aducanumab	Approved	Anti-amyloid monoclonal antibody	All stages of AD
Neuropharma	TauClear	Phase 2	Anti-tau aggregation	Tau pathology

Differentiators for CORTAN:

• Targets tau protein directly rather than amyloid plaques.
• Oral administration: user-friendly compared to injectable counterparts.
• Potential for disease-modifying effects if Phase 2 results translate to clinical benefit.

Regulatory and Patent Outlook:

• Patent filed in Q1 2022; patent protection extends to 2032.
• Regulatory pathways favor expedited review pathways (Fast Track, Breakthrough Therapy), depending on Phase 3 results.

What Are the Market Projections for CORTAN?

Revenue Projections:

Year	Global Sales (USD billion)	Assumptions
2024	0.1	Limited initial approval, focused on early adopters
2026	0.5	Expanded approval, stabilization of efficacy data
2030	2.8	Market penetration and formulation improvements

Key Drivers:

• Unmet need for disease-modifying treatments.
• Increasing diagnosis rate due to aging population.
• Growing acceptance of tau-targeted therapies.

Risks & Barriers:

• Clinical efficacy delays.
• Safety concerns impacting registration.
• Competitive pressures from established and pipeline drugs.

Market Access & Pricing:

• Anticipated price range: USD 25,000–USD 35,000 per annum.
• Reimbursement likely contingent on demonstrated cost-effectiveness and clinical benefit.

What Are the Key Takeaways for Stakeholders?

• CORTAN is in late-stage clinical development with promising initial data but pending definitive efficacy results.
• The market for AD therapeutics is expanding, with high unmet needs and potential for rapid uptake if efficacy is confirmed.
• Competitive landscape centers around amyloid vs. tau targeting; CORTAN’s tau focus could differentiate it if validated.
• Forecasted peak sales could reach nearly USD 3 billion by 2030, assuming successful regulatory approval and market access.
• The primary risks involve clinical trial outcomes and regulatory hurdles.

FAQs

1. When is CORTAN expected to receive regulatory approval?

Approval depends on Phase 3 results, expected in 2024-2025. Regulatory submission is planned post positive Phase 2 data or interim Phase 3 readouts.

2. Will CORTAN be priced competitively?

Pricing is expected in the USD 25,000–USD 35,000 range, aligned with current disease-modifying therapies. Reimbursement will depend on clinical benefits demonstrated.

3. How does CORTAN differ from anti-amyloid drugs?

CORTAN targets tau protein aggregation, which correlates more directly with neurodegeneration progression, potentially offering a different treatment avenue than amyloid-centric drugs.

4. What is the potential market share for CORTAN?

If approved with proven efficacy, CORTAN could capture 10–15% of the global AD therapeutics market by 2030, equating to USD 1–2 billion in annual sales.

5. What upcoming milestones should investors watch?

• Completion and results of Phase 2 trial (expected late 2023).
• Submission and acceptance of Phase 3 protocol.
• Regulatory interactions and reviews scheduled for 2024–2025.
• Market entry and adoption rates post-approval.

References

1. Grand View Research. (2023). Alzheimer’s Disease Therapeutics Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/alzheimers-disease-therapeutics-market