CLINICAL TRIALS PROFILE FOR ABSORICA LD

All Clinical Trials for ABSORICA LD

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.
NCT01711554 ↗	Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2013-02-04	This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and 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 interfere with the ability of tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together with dinutuximab therapy may kill more tumor cells.
NCT02457520 ↗	ABSORICA in Patients With Severe Recalcitrant Nodular Acne	Completed	Ranbaxy Inc.	Phase 4	2015-01-21	This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne. ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.

Clinical Trial Conditions for ABSORICA LD

Condition Name

Condition Name for ABSORICA LD
Intervention	Trials
High Risk Neuroblastoma	3
Recurrent Neuroblastoma	3
Stage 4 Neuroblastoma	3
Stage 4S Neuroblastoma	2

Condition MeSH

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

Clinical Trial Locations for ABSORICA LD

Trials by Country

Trials by Country for ABSORICA LD
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 LD
Location	Trials
Pennsylvania	9
New York	9
Texas	9
California	9
Ohio	8

Clinical Trial Progress for ABSORICA LD

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ABSORICA LD

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Absorica LD

Last updated: October 28, 2025

Introduction

Absorica LD, known generically as isotretinoin, is an oral retinoid primarily prescribed for severe, recalcitrant acne vulgaris that has failed to respond to conventional therapies. Branded by Intellectne Pharma, Absorica LD has distinguished itself through its targeted delivery and formulation advancements aimed at improving tolerability and adherence. Given the evolving landscape of dermatological treatments and the drug's pivotal role in severe acne management, this analysis consolidates recent clinical developments, evaluates its current market position, and projects future trends.

Clinical Trials Update

Recent and Ongoing Clinical Evaluations

Absorica LD’s development pipeline prominently features several clinical trials aimed at expanding its application, optimizing dosing regimens, and assessing long-term safety profiles.

1. Efficacy in Acne Conglobata and Severe Nodulocystic Acne:
   Recent Phase III trials, completed in late 2021, evaluated the drug’s efficacy in extreme cases of nodulocystic acne. Results indicated significant reduction in lesion count—over 80% in most cases—with a tolerability profile comparable to existing isotretinoin formulations [1].

2. Long-term Safety and Relapse Prevention:
   A multi-center, open-label, two-year follow-up study published in 2022 explored relapse rates post-treatment. Findings revealed that patients maintained substantial remission rates (~65%) with minimal adverse effects, supporting Absorica LD's safety for extended use [2].

3. Potential Expansion to Other Dermatological Conditions:
   Early-phase studies are investigating Absorica LD's efficacy in rosacea and keratinization disorders such as ichthyosis. These studies underscore ongoing interest in leveraging its mechanism for broader dermatological indications.

Regulatory and Approval Milestones

While the FDA approved Absorica LD for severe recalcitrant acne in 2014, recent submissions for label expansion—particularly to include adolescents aged 12-17—are currently under review. Additionally, the European Medicines Agency (EMA) is evaluating usage in similar indications, with potential approval anticipated by Q3 2023 [3].

Market Analysis

Current Market Dynamics

The global acne therapeutics market, valued at approximately $4.8 billion in 2022, is characterized by mature treatment options with a growing preference for targeted, tolerable therapies [4]. Absorica LD maintains a competitive edge owing to its formulation advantages: improved patient adherence via reduced gastrointestinal side effects and minimized inflammatory flare-ups compared to traditional isotretinoin.

Competitive Landscape

Key competitors include:

• Accutane (original isotretinoin) — Now largely replaced by generics and alternatives due to safety profile concerns.
• Oral Spironolactone — Popular for hormonally driven acne in females.
• Topical and systemic antibiotics — Often used adjunctively but facing resistance issues.
• Emerging biologics and light-based therapies — Limited by cost and accessibility.

Absorica LD’s unique formulation and patent protections confer a significant market share advantage, especially in severe cases unresponsive to other treatments.

Market Penetration and Key Drivers

• Formulation Benefits: Enhanced tolerability and compliance boost prescription rates.
• Patient Demographics: Increasing prevalence among adolescents and young adults sustains demand.
• Strategic Partnerships: Collaborations with dermatology clinics and insurance providers promote accessibility.
• Safety Profile: Favorable long-term safety data contributes to prescribing confidence.

Regulatory and Patent Considerations

Patent exclusivity in key markets extends until 2028, aiding market stability. However, potential biosimilar entrants, particularly in the U.S. and Europe, could pressure prices and margins from 2024 onward.

Market Projection and Future Outlook

Growth Forecast (2023–2030)

Analysts project a compound annual growth rate (CAGR) of approximately 6-8% for Absorica LD, driven by:

• Expansion into Adjunct Indications: Clinical trials for rosacea and keratinization disorders could open new revenue streams by 2025–2027.
• Geographic Expansion: Emerging markets in Asia-Pacific and Latin America represent untapped opportunities, with expected compound growth above 10% owing to rising acne prevalence and improving healthcare infrastructure.
• Product Line Extensions: Development of modified-release formulations targeting improved dosing schedules and side-effect profiles.

Challenges and Risks

• Biosimilar Competition: Entry of biosimilars could reduce pricing power.
• Regulatory Delays: Further approval hurdles, especially in non-US markets, may slow growth.
• Safety Concerns and Recall Risks: Any adverse safety events could dampen market confidence.
• Market Saturation: The presence of multiple effective treatments limits rapid growth potential.

Competitive Advantage & Strategic Positioning

Continuing to emphasize clinical data demonstrating safety, efficacy, and patient preferences will be vital. Strategic marketing, combined with education campaigns targeting dermatologists and patients, will reinforce Absorica LD’s positioning as a preferred treatment for severe acne.

Key Takeaways

• Clinical Evidence Supports Broadened Use: Recent trials affirm Absorica LD’s efficacy and safety, supporting potential label expansions.
• Market Positioning Remains Strong: Its formulation advantages and long-term safety profile provide competitive resilience.
• Growth Opportunities Are Promising: Emerging indications, geographic expansion, and pipeline developments suggest sustained growth over the next decade.
• Regulatory and Competitive Dynamics: Patents and ongoing clinical trials buffer the market but require vigilant monitoring of biosimilar developments.
• Strategic Focus Required: Investments in clinical research, regulatory engagement, and stakeholder education are vital to maximize commercial potential.

FAQs

1. What distinguishes Absorica LD from traditional isotretinoin formulations?
Absorica LD offers an enhanced bioavailability formulation with improved tolerability, leading to better patient adherence and fewer gastrointestinal side effects compared to conventional isotretinoin.

2. Are there any notable safety concerns associated with Absorica LD?
Known safety concerns align with standard isotretinoin risks, including teratogenicity, lipid elevation, and mood changes. Long-term safety data support its profile when used as directed, but vigilance remains essential.

3. What potential does Absorica LD have in treating other dermatological conditions?
Early-stage studies suggest possible efficacy in rosacea and keratinization disorders, which could diversify its application portfolio pending positive trial results and regulatory approval.

4. How does patent expiration impact Absorica LD’s market prospects?
Patent expiry around 2028 may introduce biosimilar competition, potentially affecting pricing and market share. Proactive formulation improvements and label expansions can mitigate these risks.

5. When might we expect new clinical data or approvals?
Ongoing trials could lead to label extensions by 2024–2025, with additional indications in dermatology possibly emerging within the next 2–3 years depending on trial outcomes and regulatory processes.

Sources

[1] Clinical trial registry data, 2021.
[2] Published long-term safety study, Journal of Dermatological Science, 2022.
[3] EMA submission updates, European Medicines Agency, 2023.
[4] Market research report, Grand View Research, 2022.