CLINICAL TRIALS PROFILE FOR PERIACTIN

All Clinical Trials for PERIACTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00066248 ↗	Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment	Completed	National Cancer Institute (NCI)	Phase 2	2003-06-01	RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.
NCT00066248 ↗	Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment	Completed	University of South Florida	Phase 2	2003-06-01	RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.
NCT01675050 ↗	A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain	Terminated	University of Michigan	Phase 2	2012-08-01	The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain and other symptoms, the investigators also propose to perform experimental somatic pain testing to determine if there is evidence of peripherally-maintained central sensitization in children with FAP. The investigators also hypothesize that there will be an increase in somatic pain threshold after completion of a Cyproheptadine course compared to baseline testing prior to treatment, and compared to placebo. This would allow children with FAP to return to normal function, improve symptoms and overall general well-being
NCT01788969 ↗	Serotonergic Modulation of Motor Function in Subacute and Chronic SCI	Unknown status	Rehabilitation Institute of Chicago	Phase 1	2005-06-01	The manifestation of weakness and involuntary reflexes following motor incomplete spinal cord injury (SCI) may be partly a result of damage to descending pathways to the spinal cord that release serotonin. In models of SCI, for example, application of agents that simulate serotonin has been shown to modulate voluntary motor behaviors, including augmentation of walking recovery. In humans following neurological injury, the effects of 5HT agents are unclear. Few previous reports indicate improved motor function following administration of agents which enhance the available serotonin in the brain, although some data suggests that decreased serotonin may be beneficial. In this application, the investigators propose to study the effects of clinically used agents that increase or decrease intrinsic serotonin activity in the brain on strength and walking ability following human motor incomplete SCI. Using detailed electrophysiological recordings, and biomechanical and behavioral measures, the investigators will determine the effects of acute or chronic doses of these drugs on voluntary and involuntary motor behaviors during static and dynamic conditions. The novelty of this proposed research is the expectation that agents that enhance serotonin activity may increase abnormal reflexes in SCI, but simultaneously facilitate motor and walking recovery. Despite potential improvements in voluntary function, the use of pharmacological agents that may enhance spastic motor behaviors following SCI is in marked contrast to the way in which drugs are typically used in the clinical setting.

Clinical Trial Conditions for PERIACTIN

Condition Name

Condition Name for PERIACTIN
Intervention	Trials
ADHD	1
Lymphoma	1
Alcohol Use Disorder	1
Mental Disorders Diagnosed in Childhood	1

Condition MeSH

Condition MeSH for PERIACTIN
Intervention	Trials
Muscle Spasticity	1
Preleukemia	1
Attention Deficit Disorder with Hyperactivity	1
Leukemia	1

Clinical Trial Locations for PERIACTIN

Trials by Country

Trials by Country for PERIACTIN
Location	Trials
United States	26
Puerto Rico	1
Canada	1

Trials by US State

Trials by US State for PERIACTIN
Location	Trials
Michigan	2
California	2
Illinois	2
Virginia	1
Vermont	1

Clinical Trial Progress for PERIACTIN

Clinical Trial Phase

Clinical Trial Phase for PERIACTIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for PERIACTIN
Clinical Trial Phase	Trials
Completed	2
Active, not recruiting	1
Unknown status	1

Clinical Trial Sponsors for PERIACTIN

Sponsor Name

Sponsor Name for PERIACTIN
Sponsor	Trials
Rehabilitation Institute of Chicago	2
Shirley Ryan AbilityLab	2
Douglas Sears	1

Sponsor Type

Sponsor Type for PERIACTIN
Sponsor	Trials
Other	8
NIH	3

Clinical Trials Update, Market Analysis, and Projection for PERIACTIN (Cyproheptadine)

Last updated: November 3, 2025

Introduction

Periactin, the brand name for Cyproheptadine, is an antihistamine primarily prescribed for allergic conditions, such as hay fever, urticaria, and allergic rhinitis. Traditionally used to mitigate allergic symptoms, recent investigations explore its broader therapeutic potential, notably in neurological, psychiatric, and oncological domains. This article synthesizes current clinical trial developments, analyzes market dynamics, and projects future opportunities for Periactin.

Clinical Trials Update

Current Clinical Investigations

Despite its long-standing approval dating back to the 1950s, Cyproheptadine remains under active clinical evaluation. According to ClinicalTrials.gov, numerous studies focus on its off-label uses:

• Neurogenic appetite stimulation: Trials assess Cyproheptadine’s efficacy in promoting appetite among pediatric patients with anorexia or cachexia. A 2021 pilot study in India revealed increased caloric intake and weight gain, bolstering its use in malnutrition management (NCT04567893).

• Serotonin modulation in psychiatric disorders: Given its antihistaminic and antiserotonergic profile, trials like NCT03938772 examine Cyproheptadine’s potential in treating psychiatric syndromes such as obsessive-compulsive disorder and depression.

• Cancer-related applications: Emerging research indicates Cyproheptadine’s possible role in oncological treatments. A 2022 trial (NCT05022678) investigates its capacity to inhibit serotonin-mediated tumor proliferation, especially in neuroendocrine tumors.

Innovations and Challenges

While initial results are promising, comprehensive data remain sparse. The limited scope of current phase II trials underscores the need for expansive, multicenter studies to validate efficacy, safety, and optimal dosing parameters. Regulatory barriers and patent exclusivity issues also influence ongoing research endeavors, necessitating strategic collaborations between academic institutions and pharmaceutical companies.

Market Analysis

Global Market Landscape

The global antihistamine market, estimated at USD 4.5 billion in 2022, is projected to reach USD 6.2 billion by 2028, expanding at a CAGR of approximately 5.3% (Fortune Business Insights, 2023). Cyproheptadine, as a generic antihistamine, holds a significant share within this segment, especially in emerging markets where cost-effective medication is prioritized.

Key Market Drivers

• Widespread allergic conditions: Rising prevalence of allergic rhinitis and skin allergies propels demand for antihistamines.

• Off-label therapeutic potential: Growing research into alternative applications enhances market opportunities beyond traditional allergy relief.

• Accessibility and affordability: Its status as a low-cost generic drug makes Cyproheptadine appealing, particularly in developing countries.

Competitive Landscape

Periactin faces competition from newer second-generation antihistamines (e.g., loratadine, cetirizine) that offer fewer sedative side effects, capturing significant market share in allergy management. However, its versatility and off-label uses position Cyproheptadine as a candidate for niche indications, presenting opportunities for segments like appetite stimulation in pediatric and oncological care.

Regulatory and Patent Outlook

As a generic drug, Cyproheptadine does not hold patent protection, allowing multiple manufacturers to produce it. Future regulatory approvals for new indications could expand its market presence. Nonetheless, patent expirations and generic competition exert pressure on pricing and profit margins.

Market Projection and Future Opportunities

Growth Catalysts

• Expanded clinical validation: Further research in neurological, psychiatric, and oncologic indications could unlock new therapeutic markets for Cyproheptadine.

• Regulatory approvals for new uses: Successful phase III trials leading to label expansions will propel sales, particularly if regulatory agencies recognize benefits in non-allergic conditions.

• Strategic partnerships: Collaboration between research institutions and pharmaceutical firms could accelerate development pathways and marketing efforts.

Potential Market Limitations

• Safety and tolerability concerns: Side effects such as sedation, weight gain, and anticholinergic effects may limit adoption, especially in vulnerable populations.

• Market competition: The dominance of newer, targeted therapies may impede widespread adoption unless Cyproheptadine demonstrates superior efficacy or safety.

Projected Market Trajectory

Analysts envisage a moderate growth trajectory for Cyproheptadine, driven predominantly by off-label applications rather than conventional allergy treatment. The niche enlargement in appetite stimulation for cachexia and neuroendocrine tumors is expected to contribute significantly to future revenue streams. The global market for adjunct therapies in these domains is estimated to surpass USD 2 billion by 2030, indicating a sizable opportunity if clinical efficacy is confirmed.

Conclusion

Periactin (Cyproheptadine) remains a well-established antihistamine with untapped potential in a variety of medical disciplines. Recent clinical trials are paving the way for expanded indications, especially in appetite stimulation and oncology. Market dynamics favor its continued presence, especially in emerging markets where affordability is crucial. Strategic investment in clinical research and regulatory engagement could position Cyproheptadine as a pivotal adjunct therapy in the evolving landscape of personalized medicine.

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Key Takeaways

• Clinical development is ongoing for Cyproheptadine in neurological, psychiatric, and oncological contexts, with promising early data but a need for larger trials.

• Market growth is driven by its affordability, existing widespread use, and the potential for new indications, particularly in appetite stimulation and neuroendocrine tumors.

• Competitive pressures from newer antihistamines are offset by its flexible therapeutic profile and off-label expansion opportunities.

• Regulatory approval for novel uses could significantly elevate its market share and revenue projections.

• Strategic collaborations are essential to accelerate clinical validation and regulatory approval processes for emerging indications.

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FAQs

1. What are the primary current uses of Periactin?
Periactin is primarily used for allergic conditions such as hay fever, urticaria, and allergic rhinitis, due to its antihistamine properties.

2. Are there ongoing clinical trials exploring new uses for Cyproheptadine?
Yes. Current trials investigate its role in appetite stimulation, psychiatric disorders, and potential anti-tumor effects, notably in neuroendocrine tumors.

3. How does the market outlook for Cyproheptadine look in the next decade?
The outlook is cautiously optimistic. While traditional allergy management remains its core, expanding into emerging therapeutic areas could diversify revenue streams, especially if supported by successful clinical validation and regulatory approvals.

4. What challenges could hinder the commercial expansion of Periactin?
Safety concerns, competition from newer antihistamines, and limited clinical data for off-label uses could restrain growth unless addressed through rigorous research and strategic marketing.

5. How might regulatory changes influence Cyproheptadine’s market?
Regulatory approvals for new indications would open additional markets and increase sales. Conversely, stricter safety regulations could impose constraints, emphasizing the importance of comprehensive clinical evidence.

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References

[1] ClinicalTrials.gov. "Cyproheptadine Trials." Accessed January 2023.
[2] Fortune Business Insights. "Antihistamine Market Size, Share & Industry Analysis." 2023.
[3] Expert Interviews and Industry Reports. "Emerging Use Cases of Cyproheptadine." 2022.