CLINICAL TRIALS PROFILE FOR TRANSDERM-NITRO

All Clinical Trials for TRANSDERM-NITRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00716014 ↗	Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita	Completed	Pachyonychia Congenita Project	Phase 1	2008-01-01	Pachyonychia congenita (PC) is a rare, autosomal dominant keratin disorder affecting the nails, skin, oral mucosae, larynx, hair and teeth. Pathogenic mutations in keratin K6a, K6b, K16 or K17 act via a dominant negative mechanism, leading to manifestations of the disease. The most disabling PC symptom is a painful plantar blistering and keratoderma that requires use of ambulation devices in more than 50 percent of patients. Despite our understanding of the molecular basis of PC, current treatment is limited to mechanical removal of the thick calluses, non-specific topical keratolytics, and oral retinoids, none of which alleviates blistering or plantar pain satisfactorily. A public charity, PC Project, has been founded to support the development of treatments for PC (www.pachyonychia.org). In collaboration with this charity, a small company, TransDerm, Inc., has developed a small interfering RNA (siRNA) that specifically targets a mutation in one of the PC keratins, K6a. As this siRNA targets a single nucleotide mutation, it will only be effective against PC subjects harboring this specific mutation. There are currently only six known patients who carry this mutation in the International Pachyonychia Congenita Research Registry, but three of these patients live in Salt Lake City (a mother and two of her children). We propose to perform a Phase Ib clinical trial to test the safety and tolerability of TD101 in PC patients carrying an N171K mutation. We will complete treatment of the adult patient prior to recruitment of the minors.
NCT03029650 ↗	Scopolamine Patch Pharmacokinetics in Healthy Adults	Completed	University of Minnesota	Phase 4	2016-11-01	The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
NCT03029650 ↗	Scopolamine Patch Pharmacokinetics in Healthy Adults	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 4	2016-11-01	The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
NCT03029650 ↗	Scopolamine Patch Pharmacokinetics in Healthy Adults	Completed	University of Iowa	Phase 4	2016-11-01	The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
NCT03920644 ↗	Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels	Unknown status	Naval Aeromedical Research Unit, Dayton	Phase 3	2019-04-01	This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will be conducted aboard military ships undergoing military operations or aboard commercial boats rented for the study to obtain data in a real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.0 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.
NCT04219982 ↗	DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness	Terminated	Repurposed Therapeutics, Inc.	Phase 2/Phase 3	2018-06-29	Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.
NCT04272255 ↗	Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness	Recruiting	Repurposed Therapeutics, Inc.	Phase 3	2019-04-22	This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled and open label active-controlled study to identify the safety and efficacy of a repeated-dose regimen of DPI-386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of motion sickness. The study will be conducted aboard Navy fleet or Marine ships undergoing military operations to obtain data in an operationally relevant real world environment.

Clinical Trial Conditions for TRANSDERM-NITRO

Condition Name

Condition Name for TRANSDERM-NITRO
Intervention	Trials
Motion Sickness	2
Pachyonychia Congenita	1
Prevention of Nausea Associated With Motion Sickness	1
Treatment of Nausea Associated With Motion Sickness	1

Condition MeSH

Condition MeSH for TRANSDERM-NITRO
Intervention	Trials
Motion Sickness	3
Nausea	1
Pachyonychia Congenita	1
Nails, Malformed	1

Clinical Trial Locations for TRANSDERM-NITRO

Trials by Country

Trials by Country for TRANSDERM-NITRO
Location	Trials
United States	5

Trials by US State

Trials by US State for TRANSDERM-NITRO
Location	Trials
Ohio	3
Iowa	1
Utah	1

Clinical Trial Progress for TRANSDERM-NITRO

Clinical Trial Phase

Clinical Trial Phase for TRANSDERM-NITRO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TRANSDERM-NITRO
Clinical Trial Phase	Trials
Completed	2
Recruiting	1
Terminated	1

Clinical Trial Sponsors for TRANSDERM-NITRO

Sponsor Name

Sponsor Name for TRANSDERM-NITRO
Sponsor	Trials
Repurposed Therapeutics, Inc.	2
Pachyonychia Congenita Project	1
University of Minnesota	1

Sponsor Type

Sponsor Type for TRANSDERM-NITRO
Sponsor	Trials
Other	4
Industry	2
U.S. Fed	1

TRANSDERM-NITRO Market Analysis and Financial Projection

Last updated: May 4, 2026

Clinical Trials Update, Market Analysis, and Projection: TRANSDERM-NITRO

No complete, reliable identification of the drug “TRANSDERM-NITRO” (active ingredient, developer, approved indications, and regulatory status) is present in the provided context. Without that, clinical-trial tracking, patent-life mapping, market sizing, and projection cannot be produced with the required specificity and accuracy.

What is TRANSDERM-NITRO in regulatory and clinical-trial terms?

TRANSDERM-NITRO is not uniquely identifiable from the name alone. “Nitro” products can refer to multiple therapeutic categories (e.g., nitric oxide donors, nitrate/nitroglycerin formulations, or unrelated “nitro” branding used for different actives), and “Transderm” can map to various transdermal delivery technologies.

Are there actionable clinical trials updates for TRANSDERM-NITRO?

Not determinable from the provided information. A clinical-trials update requires at minimum:

• Active ingredient(s) and strength
• Route and formulation details (patch, gel, system)
• Sponsor/developer entity
• Indication(s)
• Trial registry identifiers (e.g., NCT/EudraCT/CTIS) Without the unique drug identity, trial matching is not possible.

What is the market footprint and forecast for TRANSDERM-NITRO?

Not determinable from the provided information. A market model requires:

• Country coverage and approved indication(s)
• Competitive set (branded and generic comparators)
• Pricing basis (WAC, net, payer mix where available)
• Uptake drivers (guideline position, formulary access, substitution behavior) Without unique identity and approved scope, market sizing and projection would be non-actionable.

Key Takeaways

• TRANSDERM-NITRO cannot be mapped to a single, verifiable drug dossier using only the provided name.
• Clinical-trials update, market analysis, and forecast require unique identification (active ingredient, sponsor, indication, and regulatory status).

FAQs

1. What inputs are required to produce a clinical trials update for a named drug?
   The drug’s active ingredient, formulation, sponsor, and registry identifiers.

2. Why can’t a market projection be produced from a product name alone?
   Multiple products can share similar brand naming, and market sizing depends on indication, approved geography, dosing form, and competitive set.

3. Can “nitro” branding correspond to different actives?
   Yes. “Nitro” can appear across different therapeutic mechanisms and formulations, so identity must be confirmed at active-ingredient level.

4. What makes a trial update “actionable” for investors?
   Linked trial identifiers, enrollment status, endpoints, readout timing, and whether results affect regulatory strategy.

5. What would qualify as sufficient identity for TRANSDERM-NITRO?
   The active ingredient, dosage form and strength, developer/sponsor, and at least one regulator-linked identifier (e.g., EMA/US label or trial registry ID).

References

[1] No sources were provided or identifiable from the prompt.