CLINICAL TRIALS PROFILE FOR TRIAMINIC-12

All Clinical Trials for TRIAMINIC-12

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01676844 ↗	Investigating a New Way of Giving Medicine to Newborn and Preterm Babies	Unknown status	University of Strathclyde	Phase 2	2013-02-01	There is a deficit in the number of 'age-appropriate' formulations available for the delivery of medicines to children. Liquid preparations are considered the 'gold standard' for delivering medicines to children however many of these are formulated using ingredients which can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal babies (< 4 weeks old) who do not possess the metabolic processes and mature organ function of older children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in the saliva, releasing the active ingredient(s) without the need for chewing or water, making them ideally suited to patients who find it difficult to swallow other oral dosage forms such as tablets or capsules. The aim of this study is to demonstrate that OTFs can offer a safe and effective alternative for oral administration of phosphate supplements to neonatal infants for the treatment of hypophosphataemia and osteopenia of prematurity. It is hypothesised that this treatment will be equal to standard therapy using an oral solution. Babies born before 32 weeks gestational age are routinely supplemented with oral phosphate as soon as they have been established on oral feeds in order to prevent bone disorders such as osteopenia. Babies recruited to this study will be given phosphate supplementation as per NHS Greater Glasgow and Clyde guidelines. This single-centre cross-over study will take place in the intensive care and special care baby units at the Princess Royal Maternity in Glasgow. The investigators aim to recruit 20-30 babies and will use blood phosphate levels (obtained from routine sampling only) to evaluate treatment effect. Babies will be randomised to receive either OTFs or oral solution of potassium acid phosphate for 2 weeks followed by 2 weeks of the other therapy. The investigators hypothesise that OTF treatment will be equivalent to standard oral solution.

Clinical Trial Conditions for TRIAMINIC-12

Condition Name

Condition Name for TRIAMINIC-12
Intervention	Trials
Hypophosphataemia	1
Osteopenia of Prematurity	1

Condition MeSH

Condition MeSH for TRIAMINIC-12
Intervention	Trials
Bone Diseases, Metabolic	1
Premature Birth	1
Hypophosphatemia	1

Clinical Trial Locations for TRIAMINIC-12

Trials by Country

Trials by Country for TRIAMINIC-12
Location	Trials
United Kingdom	1

Clinical Trial Progress for TRIAMINIC-12

Clinical Trial Phase

Clinical Trial Phase for TRIAMINIC-12
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRIAMINIC-12
Clinical Trial Phase	Trials
Unknown status	1

Clinical Trial Sponsors for TRIAMINIC-12

Sponsor Name

Sponsor Name for TRIAMINIC-12
Sponsor	Trials
University of Strathclyde	1

Sponsor Type

Sponsor Type for TRIAMINIC-12
Sponsor	Trials
Other	1

TRIAMINIC-12: Clinical Trials Update, Market Analysis, and 10-Year Projection

Last updated: May 9, 2026

What is TRIAMINIC-12 (and why does the evidence matter)?

No reliable, citable basis is available to identify TRIAMINIC-12 as a specific drug product (active ingredient, formulation, sponsor, regulatory status, or clinical trial registration) from the information provided. Without that, it is not possible to produce a complete, accurate clinical trials update or market projection.

Which clinical trials exist for TRIAMINIC-12?

No citable clinical trial registry entries (ClinicalTrials.gov, EU CTR, WHO ICTRP) can be tied to “TRIAMINIC-12” based on the information provided. Without identifiable trial records, it is not possible to state:

• trial phase and design (randomized, placebo-controlled, dosing regimen)
• enrollment and completion status
• primary endpoints (efficacy, safety, biomarkers)
• results (interim or final) and dates

What is the TRIAMINIC-12 regulatory status?

No citable evidence is available to confirm:

• investigational new drug (IND) status in the US
• marketing authorization applications (EMA/CHMP, national agencies)
• approval status in any jurisdiction
• orphan designation, fast-track, breakthrough therapy, PRIME, or similar programs

Who sponsors TRIAMINIC-12 and what are the dose and target claims?

No citable evidence is available to confirm:

• sponsor and manufacturing chain
• mechanism of action and target claim
• indication(s) and dosing regimen(s)
• formulation details (route, strength, release profile)

What does the TRIAMINIC-12 market look like today?

No citable evidence is available to establish:

• the therapeutic area and indication
• addressable patient population
• pricing benchmarks or reimbursement structure
• competitive landscape (approved brands, generics, and pipeline assets)
• market size or segment breakdown

What is the competitive set and how would TRIAMINIC-12 be priced?

No citable evidence is available to identify:

• direct competitors by mechanism and line of therapy
• efficacy and safety differentiators
• expected payer value proposition
• price range and uptake assumptions

10-year market projection for TRIAMINIC-12

No citable evidence is available to create an evidence-based projection tied to TRIAMINIC-12’s indication, launch year, penetration curve, price, or competitor response.

Projection framework (cannot be populated for TRIAMINIC-12 without identification)

Model input	Needed to build projection	Status for TRIAMINIC-12
Indication and line of therapy	patient pool, standard of care	Not identified
Launch timing	year of approval and ramp	Not identified
Pricing and reimbursement	list price, net price, access	Not identified
Clinical differentiation	response rates, durability, safety	Not identified
Competition	market share displacement	Not identified
Uptake curve	S-curve assumptions and constraints	Not identified

Key Takeaways

• TRIAMINIC-12 cannot be mapped to a specific drug identity using the provided information, so clinical trials, regulatory status, and market sizing cannot be produced accurately.
• No evidence-based projection can be generated without identifiable trial and product records.

FAQs

1. Is TRIAMINIC-12 approved anywhere?
   Not confirmable from the information provided.

2. Are there active clinical trials for TRIAMINIC-12?
   Not confirmable from the information provided.

3. What is the mechanism of action of TRIAMINIC-12?
   Not confirmable from the information provided.

4. What indication does TRIAMINIC-12 target?
   Not confirmable from the information provided.

5. Can a market forecast be computed for TRIAMINIC-12?
   Not without an identifiable indication, sponsor, clinical program, and pricing basis.

References

[1] No citable sources were used because TRIAMINIC-12 could not be identified to a specific drug product, sponsor, or trial registry record based on the information provided.