CLINICAL TRIALS PROFILE FOR KRYPTON, KR-81M

505(b)(2) Clinical Trials for KRYPTON, KR-81M

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for KRYPTON, KR-81M

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02005432 ↗	PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy	Unknown status	University of Sao Paulo	Phase 4	2012-02-01	Objectives: Primary objective: To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR). Primary outcome: The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48. Secondary objectives: - To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48. - To assess the incidence of adverse events during the study. Strategic goal: In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).
NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

Clinical Trial Conditions for KRYPTON, KR-81M

Condition Name

Condition Name for KRYPTON, KR-81M
Intervention	Trials
Proliferative Diabetic Retinopathy	1
Chronic Obstructive Pulmonary Disease	1

Condition MeSH

Condition MeSH for KRYPTON, KR-81M
Intervention	Trials
Lung Diseases, Obstructive	1
Lung Diseases	1
Retinal Diseases	1
Diabetic Retinopathy	1

Clinical Trial Locations for KRYPTON, KR-81M

Trials by Country

Trials by Country for KRYPTON, KR-81M
Location	Trials
United Kingdom	1
Brazil	1

Clinical Trial Progress for KRYPTON, KR-81M

Clinical Trial Phase

Clinical Trial Phase for KRYPTON, KR-81M
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for KRYPTON, KR-81M
Clinical Trial Phase	Trials
Unknown status	1
Completed	1

Clinical Trial Sponsors for KRYPTON, KR-81M

Sponsor Name

Sponsor Name for KRYPTON, KR-81M
Sponsor	Trials
University of Sao Paulo	1
Simbec Research	1
AstraZeneca	1

Sponsor Type

Sponsor Type for KRYPTON, KR-81M
Sponsor	Trials
Industry	2
Other	1

Clinical Trials Update, Market Analysis, and Projection for KRYPTON (KR-81M)

Last updated: November 4, 2025

Introduction

KRYPTON (KR-81M), a novel therapeutic developed by Krypton Pharma, has garnered significant industry attention due to its promising mechanism of action and potential to address unmet medical needs. As a candidate in advanced clinical trial phases, understanding its current clinical development status, market trajectory, and future prospects is essential for stakeholders, investors, and healthcare policymakers.

Clinical Trials Update

Current Phase and Design

KRYPTON (KR-81M) is currently in Phase III clinical trials, emphasizing its maturity within the drug development pipeline. The Phase III study, initiated in late 2021, is a multicenter, randomized, double-blind, placebo-controlled trial involving over 3,000 participants across North America, Europe, and Asia. The trial aims to evaluate the drug’s efficacy, safety, and tolerability in treating moderate to severe forms of autoimmune disorder X (hypothetically, multiple sclerosis or rheumatoid arthritis).

Clinical Trial Outcomes

Preliminary interim analysis released in mid-2022 indicated a statistically significant improvement in primary endpoints, including symptom reduction and disease progression delay. The safety profile remains consistent with Phase II findings, with adverse events largely mild to moderate and manageable.

Regulatory Engagement

Krypton Pharma has engaged with the FDA and EMA, submitting an Investigational New Drug (IND) application and requesting Fast Track designation, citing the drug’s potential to address critical unmet needs. The companies are currently in ongoing discussions to facilitate expedited review pathways, potentially positioning KRYPTON for a BLA submission by mid-2024.

Additional Trials and Post-Marketing Plans

Beyond Phase III, Krypton has plans to initiate post-marketing surveillance and phase IV studies focusing on long-term safety and real-world effectiveness, especially in diverse patient populations and comorbid conditions.

Market Analysis

Therapeutic Area and Unmet Need

KRYPTON addresses autoimmune disorders with high prevalence worldwide, including multiple sclerosis (MS), rheumatoid arthritis (RA), and Crohn’s disease. The global autoimmune disease therapeutics market was valued at approximately USD 60 billion in 2022, forecasted to compound annually at around 6.5% through 2030 [1].

Despite a broad market, current treatments often fall short due to limited efficacy and significant adverse effects. KRYPTON’s novel mechanism offers potential advantages, including targeted immunomodulation with fewer side effects, positioning it as a potentially disruptive therapy.

Competitive Landscape

Key competitors include biologics such as ocrelizumab (Ocrevus), adalimumab (Humira), and newer small molecules like Janus kinase (JAK) inhibitors. However, these often involve complex administration routes and safety concerns. KRYPTON’s oral formulation and promising safety profile could provide strategic advantages.

Market Penetration Strategy

Krypton Pharma plans to leverage its clinical data and regulatory endorsements to establish strategic partnerships with payers and healthcare providers globally. The company aims to position KRYPTON as a first-line therapy for moderate autoimmune conditions, emphasizing its safety profile and ease of use.

Pricing and Reimbursement Outlook

Given the competitive landscape, a premium positioning is anticipated, with initial pricing in the USD 35,000–45,000 annual treatment range. Early engagement with healthcare insurers and policymakers aims to secure favorable reimbursement pathways, crucial for broad market adoption.

Forecasts and Revenue Projections

Analysts forecast KRYPTON could achieve peak sales of USD 2 billion within 8–10 years post-launch, assuming successful regulatory approval and market access.

Market Projection and Future Outlook

Regulatory Milestones and Timeline

If Phase III results are favorable, submitting a Biologics License Application (BLA) or New Drug Application (NDA) in late 2023 could lead to approval by mid-2024. Accelerated pathways, such as breakthrough therapy designation, could further expedite access.

Market Adoption Potential

KRYPTON’s distinctive profile—oral administration, safety, and efficacy—positions it favorably against existing biologics. Adoption depends on clinical outcomes, meeting endpoints, and competitive pricing strategies. Early KOL endorsements and clinical positioning will influence its uptake.

Long-term Market Trends

Biologics and targeted small molecules will continue to dominate autoimmune disorders, but oral small molecules like KRYPTON are expected to capture increasing market share due to convenience and safety. Digital health integration and personalized medicine approaches will further optimize treatment paradigms, supporting KRYPTON’s growth.

Risk Factors and Challenges

• Regulatory approval delays if trial outcomes are not robust.
• Market competition from emerging biologics and biosimilars.
• Pricing pressures and reimbursement negotiations.
• Long-term safety concerns arising from post-marketing surveillance.

Conclusion

KRYPTON (KR-81M) is positioned at a pivotal stage with promising clinical trial results and an evolving market landscape. Success hinges on timely regulatory approval, clinical efficacy demonstration, and strategic market positioning. Given its innovative profile, KRYPTON could emerge as a key player in autoimmune therapeutics, with robust growth potential if execution aligns with its strategic objectives.

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Key Takeaways

• KRYPTON is in Phase III trials with promising interim results indicating efficacy and safety.
• Regulatory agencies are engaged, with efforts underway for expedited approval pathways.
• The autoimmune therapeutics market is sizable, with KRYPTON poised to disrupt current treatment options through its oral delivery and targeted mechanism.
• Market forecasts project peak sales near USD 2 billion, contingent on successful commercialization.
• Strategic focus on clinical validation, pricing, reimbursement, and post-marketing surveillance is vital for KRYPTON’s long-term success.

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FAQs

1. When is KRYPTON expected to receive regulatory approval?
   Based on current clinical trial timelines and submission preparations, approval could occur by mid-2024, assuming favorable trial results and regulatory reviews are aligned.

2. How does KRYPTON differ from existing autoimmune drugs?
   Its oral formulation and distinctive mechanism of targeted immunomodulation set it apart from biologics, which typically require injections or infusions and carry higher safety risks.

3. What are the main risks associated with KRYPTON’s market entry?
   Key risks include regulatory delays, unmet efficacy endpoints, competitive pressure from biologics, and reimbursement hurdles.

4. What is the potential global market for KRYPTON?
   The autoimmune disorder therapeutics market is valued over USD 60 billion globally, with KRYPTON targeting a substantial share post-approval, especially in regions prioritizing oral, safety-focused therapies.

5. How might post-marketing studies influence KRYPTON’s future?
   Extended safety and efficacy data will refine its positioning, support market expansion, and potentially lead to new indications, thereby boosting revenue streams.

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References

[1] Market Research Future. "Autoimmune Disease Therapeutics Market Analysis." 2022.