CLINICAL TRIALS PROFILE FOR PREDNISONE INTENSOL

All Clinical Trials for PREDNISONE INTENSOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026208 ↗	Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma	Completed	Stanford University	Phase 2	2001-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00408005 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-01-22	This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
NCT00501826 ↗	Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	Recruiting	GlaxoSmithKline	Phase 2	2007-07-11	This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT00501826 ↗	Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2007-07-11	This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT00501826 ↗	Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	Recruiting	M.D. Anderson Cancer Center	Phase 2	2007-07-11	This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Conditions for PREDNISONE INTENSOL

Condition Name

Condition Name for PREDNISONE INTENSOL
Intervention	Trials
Acute Lymphoblastic Leukemia	9
Untreated Adult Acute Lymphoblastic Leukemia	8
Stage IVA Prostate Cancer AJCC v8	7
B Acute Lymphoblastic Leukemia	7

Condition MeSH

Condition MeSH for PREDNISONE INTENSOL
Intervention	Trials
Leukemia	26
Lymphoma	26
Precursor Cell Lymphoblastic Leukemia-Lymphoma	25
Leukemia, Lymphoid	25

Clinical Trial Locations for PREDNISONE INTENSOL

Trials by Country

Trials by Country for PREDNISONE INTENSOL
Location	Trials
United States	872
Canada	56
Australia	24
New Zealand	11
Puerto Rico	5

Trials by US State

Trials by US State for PREDNISONE INTENSOL
Location	Trials
Texas	41
California	32
Illinois	28
Washington	27
Ohio	27

Clinical Trial Progress for PREDNISONE INTENSOL

Clinical Trial Phase

Clinical Trial Phase for PREDNISONE INTENSOL
Clinical Trial Phase	Trials
Phase 3	15
Phase 2/Phase 3	3
Phase 2	30

Clinical Trial Status

Clinical Trial Status for PREDNISONE INTENSOL
Clinical Trial Phase	Trials
Recruiting	31
Active, not recruiting	14
Not yet recruiting	12

Clinical Trial Sponsors for PREDNISONE INTENSOL

Sponsor Name

Sponsor Name for PREDNISONE INTENSOL
Sponsor	Trials
National Cancer Institute (NCI)	53
M.D. Anderson Cancer Center	18
Janssen Scientific Affairs, LLC	4

Sponsor Type

Sponsor Type for PREDNISONE INTENSOL
Sponsor	Trials
Other	54
NIH	53
Industry	21

Last updated: May 22, 2026

Prednisone Intensol (Prednisone) Clinical Trials Update, Market Analysis, and Launch-Ready Projections

Prednisone Intensol is an oral prednisone (prednisolone) liquid indicated across inflammatory and immunologic disorders. The product’s clinical development footprint is not positioned as a modern, company-sponsored pipeline program; market exposure is driven primarily by (1) generic and label-parity dynamics, (2) Medicaid and commercial formulary positioning for low-cost corticosteroid solutions, and (3) episodic substitution to tablets vs. liquid formulations.

Because this is an already-established, generic-accessible active ingredient, near-term “clinical trials updates” in the conventional pipeline sense are limited; the dominant decision variables for competitors and investors are regulatory exclusivity status, Orange Book listing coverage (if any for formulation or method-of-use), and shelf conversion economics for liquid corticosteroid products.

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What clinical trials are ongoing or recently completed for Prednisone Intensol (prednisone liquid)?

Are there active registrational trials for Prednisone Intensol specifically?

Prednisone Intensol is a dosage form of prednisone that is widely available as generics. For established, small-molecule corticosteroids, company-sponsored late-stage registrational trials are uncommon when the active ingredient and dosing are already established and therapeutically interchangeable across formulations.

Clinical-trials-related exposure typically comes from:

• Bioequivalence (BE) and bridging studies for generic liquid formulations (not “Prednisone Intensol trials” as a product brand).
• Literature-driven evidence that may support new or narrower labeling, but rarely drives brand-level development unless a formulation or delivery technology is being differentiated.
• Safety monitoring expansions that are label updates rather than new endpoints.

Which types of studies matter most for liquid prednisone products?

For investors and litigators, the most decision-relevant “trial” category for liquid corticosteroids is BE/bridging:

• BE for AUC/Cmax equivalence vs. reference brand
• Stability and in-use studies for suspension/solution integrity
• Microbial and preservative robustness for pharmacy handling
• Palatability and dosing accuracy studies when a product targets pediatric or adherence populations

Practical takeaway: any “clinical trials update” for Prednisone Intensol is more accurately a generic substitution and regulatory file-update story than a brand-sponsored efficacy story.

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What is the market size and demand drivers for prednisone oral liquid products?

Therapeutic-category demand fundamentals

Oral prednisone is one of the most used systemic corticosteroids. Demand is driven by:

• Acute inflammatory flare management (rheumatology, pulmonology, dermatology)
• Hematology and oncology supportive regimens
• Autoimmune and immunologic disease exacerbations
• Pediatric and adherence-driven use cases where liquid is preferred over tablets

Why liquid prednisone matters commercially

Liquid formulations capture incremental share because:

• Dosing flexibility for pediatrics
• Patients unable to swallow tablets
• Better adherence in some patient groups
• Pharmacy substitution patterns when formularies list “prednisone solution” in addition to tablet strengths

Pricing and reimbursement dynamics

Market economics for prednisone products generally follow:

• Strong downward trend as generics expand
• Competitive pressure from authorized generics and multi-source supply
• Acquisition of formulary placement through contract pricing and pharmacy purchasing channels
• Margin dilution at the unit level, partially offset by volume

Market implication: brand-level growth is usually not the story; share protection, contract pricing, and supply continuity are.

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How do clinical, regulatory, and patent factors influence Prednisone Intensol market projections?

What determines competitive entry timing for prednisone liquids

The key determinants are:

• FDA approval path for generics (ANDA with BE)
• Whether any Orange Book-listed patents are tied specifically to the liquid formulation, manufacturing process, or labeled method-of-use
• Patent litigation and settlement outcomes (if any Orange Book coverage blocks entry)
• Exclusivity attached to a particular NDA/supplement (rare for widely used, older corticosteroid presentations)

Why patents are usually the constraint for brand retention, not efficacy evidence

For prednisone, clinical efficacy is not the barrier; therapeutic equivalence is well established. The competitive barrier becomes:

• IP coverage tied to formulation or manufacturing
• Timing of patent expiry and any stays from litigation
• Regulatory exclusivity

Business read-across: if there is no meaningful Orange Book coverage for the liquid presentation, then market projections skew quickly toward generic normalization.

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What patents protect Prednisone Intensol (prednisone solution) and what is the expiration calendar?

Prednisone products are typically mature and often have expired composition-of-matter coverage for the active ingredient. For a brand like Prednisone Intensol, the practical question is whether the NDA or key supplements list any Orange Book patents covering:

• Liquid formulation specifics (excipients, solubilization system, concentration, preservatives)
• Manufacturing process
• Use-related claims (less common for systemic corticosteroids at this stage)

Patent calendar relevance: the launch-ready projection model hinges on whether any Orange Book-listed patents are still in force for the exact strength and dosage form.

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What is the Orange Book status of Prednisone Intensol?

The Orange Book status is the gating signal for:

• Whether Paragraph IV challenges are possible
• Whether generic approvals could enter immediately upon patent expiry
• Whether there is any listed exclusivity preventing ANDA approvals

For mature corticosteroid dosage forms, Orange Book coverage is frequently thin. If Orange Book coverage exists, the listed patents are usually held by the NDA holder or assigned to formulation/process IP owners, and their expiry drives generic timing.

Decision utility: Orange Book listings determine whether market projections should assume rapid generic erosion or extended brand-retention.

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Have any companies filed Paragraph IV challenges against Prednisone Intensol?

Paragraph IV challenges require:

• An ANDA referencing the marketed listed drug
• A certification challenging Orange Book patents

For an established prednisone product with widespread generics, the most likely market outcome is already reflected in incumbent generic availability. If any new challenges exist, they would be specific to:

• A remaining formulation/process patent
• A particular strength/presentation
• A specific NDA supplement

Market projection linkage: Paragraph IV or litigation stays would delay generic entry and temporarily stabilize price.

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How many patents cover Prednisone Intensol and how strong is the patent estate for market exclusivity?

“Strength” in prednisone liquid typically reduces to:

• Claim scope (formulation composition vs. manufacturing parameters)
• Whether generic designs can easily design around
• Litigated history (if present)
• Claim construction likelihood under prior art

Typical reality for mature corticosteroids: even if patents exist, design-around pathways can be straightforward for generics using standard liquid formulation systems, which compresses exclusivity value.

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What generic entry risks exist for Prednisone Intensol?

Risk categories

1. Regulatory risk
   • If Orange Book patents have expired or are not enforceable for the specific formulation, ANDAs can launch with limited delay.
2. IP risk
   • If there are active formulation/process patents, entry may depend on design-around or litigation outcomes.
3. Supply and contracting risk
   • Even after regulatory entry, pharmacy contracts determine realized volume.

Launch scenario mapping

• Fast erosion scenario: no enforceable listed patents for the liquid strength and direct ANDA approval. Expect steep price compression and share redistribution to multi-source products.
• Delayed erosion scenario: ongoing litigation or settlement entry dates. Brand retains share longer, but price still trends down.
• Stagnation scenario: contract bundling and supply exclusivity through distribution agreements. This does not stop generic normalization but can slow it.

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Does Prednisone Intensol face biosimilar-style competition or only generics?

Prednisone Intensol is a small molecule. It faces:

• Generic competition, not biosimilar competition.

So the competitive framework is ANDA-led and Orange Book-led, not BLA/Biosimilar exclusivity.

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How does Prednisone Intensol compare with competing oral prednisone liquids and tablets?

Key product differentiation factors

• Liquid vs tablet adherence
• Pediatric dosing flexibility
• Flavoring and dosing accuracy
• Stability and pharmacy handling characteristics
• Concentration/strength coverage for common regimens

Commercial substitution

In mature therapies:

• Tablets and liquids substitute based on patient swallowing tolerance and dosing needs.
• Formularies often list both; tier placement determines substitution speed.

Market implication: even if liquid retains a niche, total systemic prednisone demand is shared across formulations.

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What litigation affects prednisone solution market entry and pricing?

For mature products, litigation is usually about:

• Remaining Orange Book patents tied to formulation/process claims
• Method-of-use claims, if any, associated with specific dosing regimens

If litigation exists, it impacts:

• Launch timing through 30-month stays after Paragraph IV
• Settlement-based carve-outs and agreed launch dates

For market projections, the critical artifact is any settlement that specifies:

• Effective launch date per generic filer
• Agreement scope (which strengths and dosage forms)
• Any stipulated exclusivity period

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FDA regulatory status: what matters for market access of Prednisone Intensol?

Approval and labeling stability

The FDA status affecting market projections includes:

• Whether the product remains the listed reference for its strength/presentation
• Whether supplemental approvals changed formulation, concentration, or dosing instructions
• Whether any distribution or manufacturing changes triggered new regulatory review cycles

Generic labeling and interchangeability

For small molecule corticosteroids, clinical interchangeability is often assumed. Regulators focus on BE, not new endpoints.

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Market projection model for Prednisone Intensol: base case, downside, and upside

Because the product is a prednisone oral corticosteroid with mature active-ingredient economics, projections should be built on generic intensity and contract pricing rather than on clinical uptake from new trials.

Base case (most likely): continued generic erosion with stable volume share

Assumptions:

• Generic liquid and tablet availability remains broad
• Orange Book coverage does not materially extend brand exclusivity for the liquid
• Contract pricing pressures persist

Projection shape:

• Revenue declines or flat-to-down drift
• Margin compression
• Limited brand share retention

Downside: rapid share loss after any Orange Book cleared date

Assumptions:

• Remaining formulation/process patents expire or are invalidated
• Generic entrants launch across multiple strengths
• Pharmacy switching accelerates

Projection shape:

• Faster revenue drop
• Lower net pricing
• Increased channel promotions required for retention

Upside: temporary stabilization from litigation stay or settlement

Assumptions:

• Any Orange Book-listed patents remain in force and delay entry
• Settlement schedules impose launch timing constraints
• Brand maintains formulary position through supply reliability

Projection shape:

• Price stabilization for a defined window
• Gradual, not abrupt, share erosion after entry dates

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Geographic coverage: how do US dynamics translate internationally?

US prednisone liquid competition is typically:

• Multi-source generic
• Contract-driven distribution
• Orange Book and 30-month stay logic only in the US

Internationally:

• Patent and regulatory timelines differ
• Generic entry depends on local status and reference pricing regimes
• Pediatric liquid availability can influence market share differently where formulations are limited

Commercial takeaway: US market pressure often sets pricing ceilings, but local reimbursement and tender systems drive realized outcomes.

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Key data table: what must be mapped to finalize projections for Prednisone Intensol

Projection input	Why it matters	What to pull from FDA/Orange Book	Impact on revenue
Orange Book patent list for Prednisone Intensol liquid	Entry timing gate	Patent numbers, expiry, claims	Determines start of erosion
NDA supplement coverage by strength	Strength-specific launch risk	Orange Book per strength/presentation	Mix shift and price drop
Patent litigation status	Launch stay or settlement	Court docket and settlement dates	Delays entry window
Number of generic ANDAs approved	Multi-source intensity	ANDA approvals count and launch history	Accelerates price compression
Contract/formulary tier position	Net price and volume	PBM and payer status	Controls realized revenue
Supply continuity and distribution contracts	Realized shelf share	Distributor arrangements	Offsets erosion temporarily

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Key Takeaways

• Prednisone Intensol is a mature systemic corticosteroid liquid; “clinical trial updates” are not the main driver of near-term market dynamics.
• Competitive outcomes are driven by generic availability, FDA regulatory status, and any Orange Book-listed patents tied specifically to the liquid presentation.
• Market projections should assume price pressure and volume share erosion unless an Orange Book patent or litigation settlement creates a defined entry delay.
• The most decision-relevant artifacts are Orange Book listings (patent expiry by strength), any Paragraph IV events, and litigation/settlement timelines that can push launch dates.

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FAQs

1. When does generic prednisone solution typically replace a brand liquid in US pharmacies?
2. Do formulation patents on liquid corticosteroids usually survive long after active-ingredient patents expire?
3. What Orange Book listings control ANDA entry for a specific prednisone liquid strength?
4. How do settlement agreements change launch timing for generic prednisone products?
5. Is there any meaningful differentiation between prednisone tablets and liquid for payer coverage?

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References

1. FDA, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA, Drug Trials Snapshots: Prednisone-related products and FDA approval summaries. U.S. Food and Drug Administration.
3. FDA, Approved Drug Products: NDA and ANDA approval records. U.S. Food and Drug Administration.