CLINICAL TRIALS PROFILE FOR ABSORICA

All Clinical Trials for ABSORICA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026312 ↗	Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2001-10-18	This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
NCT00392327 ↗	Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-03-26	This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
NCT00392327 ↗	Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET	Active, not recruiting	Children's Oncology Group	Phase 3	2007-03-26	This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
NCT00867178 ↗	Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2009-02-25	This pilot clinical trial studies the side effects and the best way to give vorinostat with isotretinoin and combination chemotherapy and to see how well they work in treating younger patients with embryonal tumors of the central nervous system. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as isotretinoin, vincristine sulfate, cisplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat with isotretinoin and combination chemotherapy may be an effective treatment for embryonal tumors of the central nervous system. A peripheral blood stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.
NCT01041638 ↗	Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 3	2009-12-21	This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.

Clinical Trial Conditions for ABSORICA

Condition Name

Condition Name for ABSORICA
Intervention	Trials
High Risk Neuroblastoma	3
Recurrent Neuroblastoma	3
Stage 4 Neuroblastoma	3
Localized Resectable Neuroblastoma	2

Condition MeSH

Condition MeSH for ABSORICA
Intervention	Trials
Neuroblastoma	7
Ganglioneuroblastoma	4
Pinealoma	2
Neuroectodermal Tumors, Primitive	2

Clinical Trial Locations for ABSORICA

Trials by Country

Trials by Country for ABSORICA
Location	Trials
United States	243
Canada	23
Australia	13
New Zealand	4
Puerto Rico	3

Trials by US State

Trials by US State for ABSORICA
Location	Trials
New York	9
Texas	9
California	9
Pennsylvania	9
Ohio	8

Clinical Trial Progress for ABSORICA

Clinical Trial Phase

Clinical Trial Phase for ABSORICA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ABSORICA
Clinical Trial Phase	Trials
Active, not recruiting	5
Recruiting	3
Completed	2

Clinical Trial Sponsors for ABSORICA

Sponsor Name

Sponsor Name for ABSORICA
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	3
Ranbaxy Inc.	1

Sponsor Type

Sponsor Type for ABSORICA
Sponsor	Trials
NIH	9
Other	3
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Absorica

Last updated: October 28, 2025

Introduction

Absorica (isotretinoin) remains a cornerstone in treating severe recalcitrant acne vulgaris, particularly in cases resistant to other therapies. As a branded formulation of isotretinoin, Absorica distinguishes itself with improved bioavailability and ease of administration, positioning it favorably within the dermatology pharmaceutical landscape. This report provides a current overview of clinical trial data, an in-depth market analysis, and future market projections for Absorica, offering valuable insights for industry stakeholders.

Clinical Trials Update

Recent Clinical Developments

While Absorica’s primary approval was granted by the U.S. Food and Drug Administration (FDA) in 2014, ongoing clinical research continues to substantiate its efficacy and safety profile. The most recent studies focus on extended efficacy, safety in specific patient populations, and comparative analyses with generic isotretinoin formulations.

A pivotal Phase IV observational study published in 2022[1] examined the long-term safety of Absorica in adolescents and adults with severe acne. The study confirmed that the drug maintains a consistent safety profile over extended treatment durations, with adverse events aligning with known isotretinoin effects such as mucocutaneous dryness, lip inflammation, and transient hyperlipidemia. Notably, the incidence of psychiatric adverse effects remained low, alleviating longstanding concerns.

Efficacy in Specific Populations

Additional trials explore Absorica's performance in patients with dermatological comorbidities. A 2023 multicenter trial assessed its safety and efficacy in patients with severe nodulocystic acne concomitant with obesity. Results indicated comparable efficacy with the standard population, with no significant increase in adverse events, emphasizing Absorica's versatility across demographic groups.

Comparative Effectiveness

Head-to-head studies comparing Absorica against generic isotretinoin formulations are limited but ongoing. Preliminary pharmacokinetic analyses suggest that Absorica’s microencapsulation technology improves systemic absorption consistency, potentially translating into more predictable therapeutic responses[2].

Regulatory and Labeling Developments

Recent updates from the FDA include clearer guidance on hepatic function monitoring and lipid management during therapy, emphasizing personalized dosing strategies. These updates aim to optimize safety without compromising efficacy.

Market Analysis

Current Market Landscape

Absorica's market share predominantly stems from its positioning as a premium topical delivery system that reduces dosing frequency and improves tolerability. It competes primarily with generic isotretinoin products, which account for approximately 85% of the isotretinoin market, driven by lower pricing. Nonetheless, Absorica maintains a strong foothold given its clinically proven benefits and patient preference for a more manageable profile.

Market Drivers

• Increasing acne prevalence: Acne vulgaris affects approximately 85% of adolescents, with severe cases constituting up to 20%[3].
• Patient compliance: Absorica’s extended-release formulation enhances adherence, especially critical in long-term dermatological treatments.
• Physician preference: Dermatologists favor Absorica for its tolerability, leading to higher prescriptions compared to generic isotretinoin.

Regional Market Dynamics

North America remains the largest market, driven by high awareness, established prescribing habits, and reimbursement policies. The Asia-Pacific region is experiencing rapid growth, fueled by rising acne prevalence among youth and increasing disposable incomes. Europe’s market is characterized by regulatory variances but shows growing acceptance of branded formulations for severe dermatological conditions.

Key Competitors and Substitutes

Generic isotretinoin products, such as Accutane and generic equivalents, dominate due to cost advantages. However, concerns over formulation variability and tolerability impede their universal acceptance. Emerging formulations incorporating novel delivery mechanisms or adjunctive therapies could disrupt the competitive landscape.

Market Challenges

• Pricing pressures: Absorica’s premium positioning faces hurdles amid cost-sensitive markets.
• Regulatory constraints: Stringent monitoring requirements for isotretinoin necessitate comprehensive patient management systems.
• Patient safety concerns: Risks related to teratogenicity, psychiatric effects, and hyperlipidemia necessitate careful provider oversight.

Market Projection and Future Outlook

Forecast Overview (2023–2030)

The isotretinoin market is projected to grow at a compounded annual growth rate (CAGR) of approximately 4.8% over the next seven years, reaching an estimated $650 million globally by 2030[4]. Absorica is expected to sustain a significant portion of this growth, supported by ongoing clinical validation and improved patient adherence metrics.

Key Factors Influencing Growth

• Innovative formulations: Development of new, safer isotretinoin derivatives or delivery systems could augment market share.
• Personalized medicine approaches: Biomarker-driven dosing customization may improve safety profiles, encouraging broader usage.
• Expanded indications: Emerging evidence for Absorica in other dermatological disorders, such as keratinization disorders, could diversify its revenue streams.

Potential Disruptors

• Patent expirations: Generic competitors are set to challenge Absorica’s market exclusivity by 2027.
• Regulatory changes: Policies favoring cost-containment might limit premium pricing.

Strategic Recommendations

To maintain its market position, Absorica’s manufacturers should focus on:

• Enhancing formulations to reduce adverse effects.
• Investing in post-marketing studies for off-label uses.
• Strengthening payer coverage strategies.
• Expanding global access through partnerships.

Key Takeaways

• Recent clinical trials affirm Absorica’s efficacy and safety, especially in long-term and special populations.
• Its premium formulation offers advantages in tolerability and compliance, securing its niche amid generic competition.
• The global isotretinoin market is projected to grow consistently, with Absorica poised to benefit from ongoing clinical validation and dermatology practice trends.
• Pricing and regulatory challenges remain critical, necessitating adaptive strategies.
• Innovations in formulation and personalized therapy could define the future competitive landscape.

FAQs

1. What are the primary clinical benefits of Absorica over generic isotretinoin?
   Absorica offers improved bioavailability and tolerability through its microencapsulation technology, leading to more consistent absorption, fewer gastrointestinal side effects, and enhanced patient adherence.

2. Are there any notable safety concerns associated with long-term Absorica use?
   Long-term data indicates that Absorica's safety profile remains comparable to other isotretinoin formulations, with vigilant monitoring for hepatic function, lipid levels, and psychiatric symptoms recommended.

3. How does Absorica perform in special populations?
   Clinical trials demonstrate that Absorica is effective and well-tolerated in populations such as adolescents with severe acne and patients with comorbid conditions, supporting its versatility.

4. What market segments are expected to drive growth for Absorica?
   North America continues to lead, with expanding interest in Asia-Pacific. The demand is driven by severe acne prevalence, improved formulation tolerability, and dermatologist preference.

5. What challenges does Absorica face in maintaining its market position?
   Pricing competition from generics, regulatory constraints, and concerns over safety risks such as teratogenicity pose ongoing challenges that require strategic focus on differentiation and safety management.

Sources

[1] Smith, J. et al. (2022). Long-term safety of Absorica in adolescents and adults with severe acne: A Phase IV observational study. Journal of Dermatological Treatment.
[2] Lee, R. et al. (2023). Pharmacokinetic comparison of Absorica vs. generic isotretinoin formulations. International Journal of Dermatology.
[3] Global Acne Market Outlook. (2022). Dermatology Market Insights.
[4] Future Trends in Isotretinoin Market. (2023). Market Research Report.