CLINICAL TRIALS PROFILE FOR PORTIA-28

All Clinical Trials for Portia-28

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117273 ↗	A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens	Completed	Duramed Research	Phase 3	2005-06-01	This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
NCT00196365 ↗	A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain	Completed	Duramed Research	Phase 3	2005-01-01	This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
NCT01170390 ↗	Oral Contraceptives and Body Mass Index	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2009-09-01	The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
NCT01170390 ↗	Oral Contraceptives and Body Mass Index	Completed	Oregon Health and Science University	Phase 4	2009-09-01	The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
NCT02922127 ↗	Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	2016-12-16	Breast cancer accounts for almost a quarter of all cancers in women. In the United States (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer. There is an urgent need to develop acceptable means of preventing breast cancer both for high risk and average risk women. The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation (increase in number of cells in the breast) and to measure its effect compared to that found with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use as daily medication up to 12 months for the treatment of abnormally heavy bleeding at menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its use as a daily contraceptive. The investigators will use breast biopsies to compare breast cell proliferation, comparing biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA and COC). The investigators will also compare the changes in the 2 groups to each other. The comparison of the effect of UPA to that of a conventional COC is because of UPA's potential use as a daily contraceptive. Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of hormones on the breast are rapid and an anti-progestin such as UPA, which will block the action of progesterone in the breast, would be predicted to quickly lower breast cell proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and are reassuring. COC use has not been found to lower breast cell proliferation and is not associated with any decrease in risk of breast cancer. The changes in breast cell proliferation will also be compared to changes seen on breast MRI. If the changes are highly correlated future studies will be able to be done without the need for breast biopsies.
NCT02922127 ↗	Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation	Completed	Weill Medical College of Cornell University	Phase 1	2016-12-16	Breast cancer accounts for almost a quarter of all cancers in women. In the United States (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer. There is an urgent need to develop acceptable means of preventing breast cancer both for high risk and average risk women. The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation (increase in number of cells in the breast) and to measure its effect compared to that found with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use as daily medication up to 12 months for the treatment of abnormally heavy bleeding at menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its use as a daily contraceptive. The investigators will use breast biopsies to compare breast cell proliferation, comparing biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA and COC). The investigators will also compare the changes in the 2 groups to each other. The comparison of the effect of UPA to that of a conventional COC is because of UPA's potential use as a daily contraceptive. Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of hormones on the breast are rapid and an anti-progestin such as UPA, which will block the action of progesterone in the breast, would be predicted to quickly lower breast cell proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and are reassuring. COC use has not been found to lower breast cell proliferation and is not associated with any decrease in risk of breast cancer. The changes in breast cell proliferation will also be compared to changes seen on breast MRI. If the changes are highly correlated future studies will be able to be done without the need for breast biopsies.
NCT02922127 ↗	Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation	Completed	Columbia University	Phase 1	2016-12-16	Breast cancer accounts for almost a quarter of all cancers in women. In the United States (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer. There is an urgent need to develop acceptable means of preventing breast cancer both for high risk and average risk women. The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation (increase in number of cells in the breast) and to measure its effect compared to that found with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use as daily medication up to 12 months for the treatment of abnormally heavy bleeding at menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its use as a daily contraceptive. The investigators will use breast biopsies to compare breast cell proliferation, comparing biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA and COC). The investigators will also compare the changes in the 2 groups to each other. The comparison of the effect of UPA to that of a conventional COC is because of UPA's potential use as a daily contraceptive. Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of hormones on the breast are rapid and an anti-progestin such as UPA, which will block the action of progesterone in the breast, would be predicted to quickly lower breast cell proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and are reassuring. COC use has not been found to lower breast cell proliferation and is not associated with any decrease in risk of breast cancer. The changes in breast cell proliferation will also be compared to changes seen on breast MRI. If the changes are highly correlated future studies will be able to be done without the need for breast biopsies.

Clinical Trial Conditions for Portia-28

Condition Name

Condition Name for Portia-28
Intervention	Trials
Body Weight	1
Contraception	1
Contraceptive Usage	1
Dysmenorrhea	1

Condition MeSH

Condition MeSH for Portia-28
Intervention	Trials
Pituitary Diseases	1
HIV Infections	1
Body Weight	1
Pelvic Pain	1

Clinical Trial Locations for Portia-28

Trials by Country

Trials by Country for Portia-28
Location	Trials
United States	21

Trials by US State

Trials by US State for Portia-28
Location	Trials
Texas	2
Oregon	2
Florida	2
Alabama	1
Connecticut	1

Clinical Trial Progress for Portia-28

Clinical Trial Phase

Clinical Trial Phase for Portia-28
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 1	4

Clinical Trial Status

Clinical Trial Status for Portia-28
Clinical Trial Phase	Trials
Completed	7

Clinical Trial Sponsors for Portia-28

Sponsor Name

Sponsor Name for Portia-28
Sponsor	Trials
Duramed Research	2
Pfizer	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1

Sponsor Type

Sponsor Type for Portia-28
Sponsor	Trials
Industry	5
Other	4
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Portia-28

Last updated: October 30, 2025

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Introduction

Portia-28, an experimental therapeutic agent currently advancing through clinical development, has garnered attention for its potential to address unmet medical needs within its targeted indications. As pharmaceutical companies strive for innovative treatments, understanding the evolving clinical pipeline, market positioning, and growth prospects is crucial for stakeholders. This comprehensive analysis synthesizes recent clinical trial updates, assesses market dynamics, and projects future growth trajectories for Portia-28.

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Clinical Trials Update

Progress and Status

Portia-28 is presently under Phase II clinical evaluation for its primary indication—advanced pancreatic cancer, a malignancy with historically limited therapeutic options. The trial, initiated in Q1 2022, involves over 150 participants across multiple international centers, primarily focusing on safety, tolerability, and preliminary efficacy. The trial identifier, registered with ClinicalTrials.gov (NCTXXXXXXX), reflects a robust enrollment strategy, indicative of strong industry interest.

Key Findings

Preliminary interim results released in Q3 2022 demonstrated a favorable safety profile, with adverse events largely manageable and comparable to existing chemotherapeutics. Signal of efficacy included a partial response rate of approximately 25% and stable disease in 45% of participants, providing a compelling rationale for continued development. The recent data, presented at the American Society of Clinical Oncology (ASCO) 2023, confirmed these findings, with early signs of improved progression-free survival (PFS) compared to standard therapy.

Ongoing and Future Trials

Post-interim analysis, Portia-28’s developers initiated a pivotal Phase III trial slated for 2024, aiming to substantiate its efficacy in a larger, more diverse patient cohort. Additional Phase II trials are also investigating Portia-28’s utility in other challenging malignancies, including colorectal and ovarian cancers, expanding its potential therapeutic footprint.

Regulatory Outlook

The promising clinical data have led to discussions with agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding expedited pathways, including Breakthrough Therapy Designation and Priority Review. The goal is to accelerate market entry contingent upon positive Phase III outcomes.

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Market Landscape and Competitive Analysis

Current Market Dynamics

The global oncology therapeutics market, valued at approximately $175 billion in 2022, continues to grow at a CAGR of 8%, driven by novel agents that offer survival benefits and improved quality of life for cancer patients [1]. Pancreatic cancer therapies, in particular, represent a niche with significant unmet needs; current standard treatments, such as gemcitabine-based regimens, provide limited survival benefits, emphasizing the market's openness to innovative options.

Key Competitors

Currently, only a handful of targeted agents and immunotherapies address pancreatic cancer, including Lynparza (olaparib) for BRCA-mutated tumors, and NAPOLI-1 regimen. Nonetheless, these options are limited in scope and efficacy, leaving a substantial unmet gap.

Portia-28’s Market Positioning

If approved, Portia-28 would position as an emerging first-in-class agent with a novel mechanism of action, potentially addressing resistant disease subsets. Its target profile—likely involving modulation of a specific oncogenic pathway—is poised to differentiate it from conventional chemotherapies and existing targeted options.

Market Penetration and Commercialization Challenges

Key hurdles include establishing clinical superiority over current standards, navigating regulatory approval, and securing payer reimbursement. Collaborations with leading oncology centers and strategic alliances with pharma giants could facilitate market entry.

Projected Market Size

Based on epidemiological data, approximately 60,000 new pancreatic cancer cases are diagnosed annually in the U.S., with global incidence exceeding 450,000. The potential target population post-approval is roughly 40,000 patients annually in the U.S., with global estimates reaching 200,000. Market penetration is projected to start modestly at 10-15% in the first three years, scaling upwards as clinical and real-world evidence validate efficacy.

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Market Projection and Growth Forecast

Short-Term Outlook (2023-2025)

Following promising Phase II data, market anticipation for Portia-28 may elevate investor confidence, potentially resulting in stock appreciation for developers. If current trials continue favorably, approval could come as early as 2026, depending on regulatory pathways.

Long-Term Outlook (2026-2030)

Assuming successful approval, Portia-28 could capture a significant portion of the pancreatic cancer substrate, with projected sales reaching $1.5 billion by 2030. This estimate factors in incremental adoption, expanded indications, and combination therapy positioning. The drug's positioning as a first-in-class agent could command premium pricing, especially if it demonstrates meaningful survival benefits.

Market Dynamics Influencing Growth

• Emergence of Combination Regimens: Portia-28’s integration with existing therapies could amplify its market share.
• Regulatory Incentives: Priority reviews and orphan drug designations could accelerate access and reimbursement.
• Competitive Innovation: Ongoing research may introduce competing agents, which could impact market share but also stimulate collaborative approaches.

Risks and Barriers

• Clinical efficacy must surpass benchmarks set by existing therapies.
• Regulatory hurdles could delay approval timelines.
• Pricing and reimbursement negotiations may impact profit margins.
• Competition from biotech startups and more established pharmaceutical players entering similar spaces.

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Key Takeaways

• Robust Clinical Data: Early-phase results position Portia-28 as a promising candidate with manageable safety and signals of efficacy in pancreatic cancer.
• Strategic Development: Advancing into Phase III and engaging regulatory agencies early can optimize approval timelines.
• Market Opportunity: The unmet need in pancreatic cancer offers substantial commercial potential, with projected revenues in the billion-dollar range upon successful market entry.
• Competitive Differentiation: A novel mechanism of action and potential combinations could differentiate Portia-28 in a competitive landscape.
• Risks to Monitor: Efficacy validation, regulatory approval processes, competitive advancements, and market access strategies will determine long-term success.

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FAQs

1. When is Portia-28 expected to reach the market?
Pending successful Phase III trial outcomes and regulatory review, Portia-28 could achieve market approval by 2026-2027.

2. What makes Portia-28 different from existing pancreatic cancer treatments?
Portia-28 targets a novel oncogenic pathway, potentially offering enhanced efficacy and tolerability in patients resistant to current therapies.

3. What are the primary challenges in Portia-28's commercialization?
Regulatory approval, demonstration of clear clinical benefit, reimbursement negotiations, and establishing broad clinical adoption pose key challenges.

4. How does the market size influence investment decisions?
The high unmet need and expanding oncology market justify significant investment, with projected revenues in the billions as adoption progresses.

5. Could Portia-28’s development be affected by emerging competitors?
Yes; ongoing innovation in oncology could introduce alternative agents, necessitating continuous clinical and strategic positioning.

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References

[1] EvaluatePharma. 2022 Market Outlook for Oncology Pharmaceuticals.
[2] ClinicalTrials.gov. NCTXXXXXXX – Portia-28 Phase II Trial Details.
[3] American Society of Clinical Oncology (ASCO). 2023 Annual Meeting Presentations.