CLINICAL TRIALS PROFILE FOR SOTRET

All Clinical Trials for SOTRET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005576 ↗	Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 1	2001-01-01	Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells. Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation
NCT00025038 ↗	Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	2001-06-01	Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia
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.
NCT00098891 ↗	MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas	Completed	National Cancer Institute (NCI)	Phase 1	2004-10-01	Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may help cancer cells develop into normal cells. MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer. Combining MS-275 with isotretinoin may kill more cancer cells
NCT00217412 ↗	Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia	Completed	National Cancer Institute (NCI)	Phase 1	2005-08-01	This phase I trial is studying the side effects and best dose of vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may be an effective treatment for cancer.

Clinical Trial Conditions for SOTRET

Condition Name

Condition Name for SOTRET
Intervention	Trials
Recurrent Neuroblastoma	8
Regional Neuroblastoma	6
Stage 4 Neuroblastoma	5
Stage 4S Neuroblastoma	5

Condition MeSH

Condition MeSH for SOTRET
Intervention	Trials
Neuroblastoma	14
Ganglioneuroblastoma	5
Neuroectodermal Tumors, Primitive	3
Leukemia	3

Clinical Trial Locations for SOTRET

Trials by Country

Trials by Country for SOTRET
Location	Trials
United States	402
Canada	44
Australia	20
New Zealand	6
Puerto Rico	5

Trials by US State

Trials by US State for SOTRET
Location	Trials
California	17
Pennsylvania	16
Illinois	13
Texas	13
Ohio	13

Clinical Trial Progress for SOTRET

Clinical Trial Phase

Clinical Trial Phase for SOTRET
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for SOTRET
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	7
Recruiting	3

Clinical Trial Sponsors for SOTRET

Sponsor Name

Sponsor Name for SOTRET
Sponsor	Trials
National Cancer Institute (NCI)	21
Children's Oncology Group	7
Comprehensive Cancer Center of Wake Forest University	1

Sponsor Type

Sponsor Type for SOTRET
Sponsor	Trials
NIH	21
Other	9

Last updated: April 27, 2026

SOTRET Clinical Trials Update, Market Analysis, and Projection

What is SOTRET in market and clinical terms?

SOTRET is the U.S. brand name for isotretinoin (oral retinoid). In the U.S., isotretinoin is an older, well-established small-molecule therapy for severe recalcitrant nodular acne and is widely available as generics. Clinical development activity for “SOTRET” specifically is therefore limited relative to the base molecule, and market outcomes largely track regulatory, payer, and generic substitution rather than new mechanism science.

What does the clinical-trials landscape show for SOTRET/isotretinoin?

No contemporaneous, drug-specific trial stream for “SOTRET” (as a branded entry) is typically the organizing signal in public registries; isotretinoin’s clinical evidence base is dominated by older landmark work and ongoing postmarketing pharmacovigilance and risk-management activities (notably teratogenicity controls).

The most operationally relevant “trial-like” activity for isotretinoin in recent years has been risk evaluation and mitigation strategy (REMS) execution and updates rather than new pivotal phase programs under the branded label.

Practical implication: for investment and R&D planning, SOTRET behaves like a mature commodity product whose near-term trajectory is driven by:

• generic competition and price compression,
• REMS administration capacity (prescriber, pharmacy, patient workflow),
• payer formulary decisions and pharmacy benefit design,
• exposure management compliance rates.

What regulatory and REMS constraints shape access and sales?

Isotretinoin access in the U.S. is governed by the iPLEDGE REMS because of high teratogenic risk. iPLEDGE requires tightly controlled prescribing, dispensing, pregnancy testing, and documentation. These constraints affect throughput and adherence and can influence real-world utilization more than clinical outcomes.

Key iPLEDGE program elements:

• prescriber and pharmacy certification requirements,
• patient enrollment and pregnancy testing schedules,
• mandatory contraceptive requirements for patients who can become pregnant.

Source: FDA iPLEDGE program information. [1]

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Market Analysis: How does SOTRET perform in a generic-dominant category?

What drives revenue for isotretinoin brands versus generics?

In most mature markets, isotretinoin pricing and volume are shaped by:

• generic substitution after patent/exclusivity periods,
• net price vs list price compression through rebates and contracting,
• channel mix across mail order and specialty pharmacies that support REMS workflow,
• adherence and persistence impacts under REMS rules.

Because isotretinoin is long-established, branded products typically compete on availability, dosage-form continuity, and supply stability rather than differentiation.

Where does market growth come from?

For isotretinoin overall, demand growth tends to be incremental and linked to:

• acne epidemiology and treatment penetration,
• clinician prescribing patterns (including specialist-to-primary transfer),
• patient willingness to initiate therapy under monitoring,
• payer willingness to cover oral isotretinoin.

But category growth is usually muted by the same constraints:

• long-standing REMS burden,
• generic price pressure,
• no major new clinical differentiation pathway for generic-substitutable oral isotretinoin.

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Sales and Demand Projection: What is the forward trajectory for SOTRET?

What projection model fits SOTRET?

A practical projection for SOTRET must treat it as:

• mature, commoditized, and
• REMS-constrained with generic substitution as the primary downside variable.

Given that SOTRET is a branded presentation in a generic class, the expected forward path usually follows a pattern:

1. baseline unit demand linked to overall isotretinoin utilization,
2. branded share erosion or stabilization depending on contracting,
3. net revenue decline or plateau depending on price and channel coverage.

Projection logic (directional, operational)

Base case (most typical for mature branded isotretinoin):

• Units: stable to low single-digit growth tied to category utilization.
• Branded share: flat to gradually down as generics dominate.
• Net price: lower over time because of competitive rebates and substitution.

Upside scenario:

• improved channel penetration where REMS-capable distribution concentrates (some branded supply arrangements can be favored),
• formulary placement in selected managed care plans,
• consistent dosing availability that reduces dispensing friction.

Downside scenario:

• intensified payer restrictions to lowest net-cost generic SKUs,
• supply disruptions shifting volume to other dosages/competitors,
• REMS workflow bottlenecks that reduce initiation rates.

Projected market outcome (qualitative)

SOTRET’s near-to-medium term is most likely to show:

• revenue stability with gradual brand share pressure, and
• limited upside from clinical innovation because isotretinoin’s main competitive science is already established and generics are interchangeable.

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Business and R&D Implications for Decision-Makers

What should investors and strategists treat as key KPIs?

For a branded oral isotretinoin product, the control tower should track:

• iPLEDGE program operational throughput at dispensing sites,
• branded net price and rebate pressure by payer cohort,
• utilization trends for severe nodular acne initiations,
• adherence and persistence under monitoring timelines,
• dose-level mix shifts (20/30/40/50 mg equivalents are typically where mix changes occur).

Where does “clinical trials update” matter for a mature isotretinoin brand?

Clinical-trials updates matter for:

• new safety signals (pharmacovigilance),
• REMS operational adjustments,
• any new evidence that changes guideline positioning or initiation thresholds.

But new pivotal development is unlikely to be the dominant driver versus system-level access and reimbursement.

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Key Takeaways

• SOTRET is isotretinoin and sits in a mature, generic-dominant oral acne category; near-term dynamics depend more on REMS execution and payer economics than new clinical differentiation.
• U.S. access is governed by iPLEDGE due to teratogenic risk, making workflow and monitoring a central commercial driver.
• Forward-looking branded performance is most likely revenue-stable with brand share pressure, with upside or downside driven by net contracting and dispensing/channel realities, not by new clinical programs.

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FAQs

1. Is SOTRET still actively studied in late-stage clinical trials?
   Isotretinoin’s core evidence is mature; for SOTRET specifically, public trial activity is typically not the primary driver versus REMS and market mechanics.

2. What regulatory program most affects isotretinoin sales in the U.S.?
   The iPLEDGE REMS program controls prescribing and dispensing because of teratogenic risk. [1]

3. How do generics change SOTRET’s market outlook?
   They compress branded net pricing and can erode branded share through substitution, while leaving overall category utilization driven by acne treatment demand and REMS capacity.

4. What could improve SOTRET performance despite generic competition?
   Superior supply continuity at key dose strengths, favorable payer contracting that preserves some formulary access, and dispensing-channel efficiencies that reduce REMS friction.

5. What should be monitored besides clinical endpoints?
   iPLEDGE throughput metrics, payer formulary changes, branded net price trends, and initiation and persistence patterns under monitoring schedules.

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References

[1] U.S. Food and Drug Administration. (n.d.). iPLEDGE REMS (isotretinoin) program. FDA. https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm