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.
NCT01788969 ↗	Serotonergic Modulation of Motor Function in Subacute and Chronic SCI	Unknown status	Shirley Ryan AbilityLab	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.
NCT01940978 ↗	A Study of Combination Therapy in Children With ADHD	Completed	Douglas Sears	Phase 4	2014-03-01	Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines such as methylphenidate. Lack of sufficient food intake has been shown to have negative effects on weight and height as well as learning and memory. There is no current treatment to prevent this loss of appetite except discontinuation or reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the return of ADHD symptoms. The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug, cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression associated with methylphenidate.

Clinical Trial Conditions for PERIACTIN

Condition Name

Condition Name for PERIACTIN
Intervention	Trials
Functional Abdominal Pain	1
Hemiparesis	1
Leukemia	1
ADHD	1

Condition MeSH

Condition MeSH for PERIACTIN
Intervention	Trials
Disease	1
Lymphoma	1
Muscle Spasticity	1
Preleukemia	1

Clinical Trial Locations for PERIACTIN

Trials by Country

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

Trials by US State

Trials by US State for PERIACTIN
Location	Trials
Michigan	2
California	2
Illinois	2
Wisconsin	1
Washington	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
Terminated	1
Active, not recruiting	1

Clinical Trial Sponsors for PERIACTIN

Sponsor Name

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

Sponsor Type

Sponsor Type for PERIACTIN
Sponsor	Trials
Other	8
NIH	3

PERIACTIN Market Analysis and Financial Projection

Last updated: May 8, 2026

PERIACTIN (cyproheptadine): Clinical Trials Update and Market Outlook

What is PERIACTIN and what is its patent situation?

PERIACTIN is the brand name for cyproheptadine, an antihistamine used for allergic conditions and off-label uses including appetite stimulation and migraine prophylaxis.

Regulatory status (US, EU, key markets)

• US (FDA): Cyproheptadine is marketed as an established medicine. PERIACTIN is not a biologic and does not follow the same modern “new molecular entity” commercialization timeline as many late-stage products.
• EU: Cyproheptadine products are widely available; commercial landscape is dominated by generics once reference product exclusivity expires.

Patent reality for business planning

• For established small-molecule antihistamines, long-term commercial protection typically comes from formulation patents, specific packaging/brand trade dress, or local registrations, not from broad substance patents.
• Under this structure, clinical development risk is often low for cyproheptadine, but revenue upside is typically constrained by generic price competition.

(The provided information is sufficient to outline category and market mechanics, but the requested deliverable requires drug-specific trial and forward projection data that must be sourced from trial registries and market databases. No such trial-level and revenue-level data was provided in the prompt.)

---

What is the clinical trials update for PERIACTIN?

No trial-level update can be produced from the information available in the prompt. A complete update requires:

• registry search results (e.g., ClinicalTrials.gov and WHO ICTRP),
• study phase, start/completion dates, locations,
• endpoints (efficacy, safety),
• recruiting status,
• and any sponsor-level changes.

Per the constraints, without those drug-specific trial details, a complete and accurate clinical trials update cannot be delivered.

---

How large is the PERIACTIN market today?

A complete market analysis requires at least one of the following:

• current sales by geography and segment (prescription vs OTC if applicable),
• branded vs generic share,
• unit volumes and net price trends,
• and explicit data sources.

The prompt does not provide those inputs, and the constraints do not allow constructing numbers without verifiable sourcing.

---

What is the market projection for PERIACTIN through 2030?

A defensible projection needs:

• historical time-series sales (typically 3 to 10 years),
• segmentation assumptions (dose forms, age group indications, specialty vs primary care),
• patent and exclusivity timeline by key countries,
• competitor pipeline and switching dynamics,
• and macro assumptions (inflation-adjusted pricing, guideline changes, payer coverage).

No sourced dataset is included in the prompt, so a complete and accurate projection cannot be produced.

---

Where does value still concentrate for cyproheptadine brands?

Even without current trial and market figures, cyproheptadine’s commercial pattern in established markets typically concentrates in:

• Retail and generic channels: small molecule antihistamines face frequent generic entry.
• Formulation and distribution: maintaining consistent dosing, stability, and supply reliability matters more than differentiation when active ingredient exclusivity is gone.
• Indication persistence: off-label use patterns can keep baseline demand, but payer scrutiny can shift utilization.

To convert this into an actionable investment view, the deliverable needs drug-specific metrics (trial starts and net sales). Those are not present.

---

Key Takeaways

• PERIACTIN is cyproheptadine, an established small-molecule antihistamine whose long-run economics are commonly driven by generic competition and formulation/distribution, not new substance patent life.
• The requested clinical trials update and market projection cannot be produced to a complete, accurate standard without drug-specific trial registry results and sourced market sales data.
• An actionable plan for R&D or investment depends on identifying whether any new clinical evidence is being generated (new indications, dose forms, real-world outcomes) and whether any protected product attributes (formulation, supply, regulatory exclusivity in specific jurisdictions) remain.

---

FAQs

1. Is PERIACTIN a prescription or OTC product in major markets?
   Market access depends on country-specific regulatory classification for cyproheptadine products; the prompt provides no jurisdictional classification data.

2. Does cyproheptadine still have significant patent protection?
   For established antihistamines, substance patents typically expire long before current commercialization; protection, if any, usually comes from specific formulation or local registrations.

3. What new clinical trials could move demand for cyproheptadine?
   The main demand movers would be phase-3 evidence in migraine prophylaxis, pediatric appetite outcomes, or comparative effectiveness studies. Trial details are not provided.

4. How does generic entry usually affect PERIACTIN revenues?
   Price compression and share migration are typical once generics enter; net revenue often tracks with branded share and payer contracting.

5. What product attributes can preserve profitability despite generics?
   Consistent supply, differentiated dose forms, brand-specific contracting, and any jurisdiction where reference product status still applies.

---

References

[1] FDA. Drug products and labels for cyproheptadine (PERIACTIN reference label and active ingredient regulatory information).
[2] EMA. European regulatory information for cyproheptadine-containing medicinal products.
[3] ClinicalTrials.gov. Cyproheptadine (PERIACTIN) search results and trial records.
[4] WHO ICTRP. Cyproheptadine trial records.
[5] IQVIA / EvaluatePharma / similar market databases. Cyproheptadine market sales, shares, and forecasts (subscription datasets).