The Critical Distinction: Research Chemical vs. Commercial Drug
The most important detail for anyone asking about the cost of trodusquemine is that it is not a commercially available medication for patients. No regulatory body, such as the U.S. Food and Drug Administration (FDA), has approved it for human or clinical use. Instead, it is classified as a research chemical, and its sale is restricted to laboratory and research purposes. Any price listed for trodusquemine is for these small, research-grade quantities, not for a patient's therapeutic dose.
Implications of being a research chemical
- No Standardized Pricing: The cost is not regulated and is not covered by insurance. It is determined by the supplier, manufacturing costs for that specific small-batch product, and the requested quantity.
- Lack of Patient Access: The general public cannot legally obtain or use trodusquemine for self-treatment.
- No Established Dosing for Humans: As it has not completed clinical trials, the safe and effective therapeutic dose for any potential human use is not established.
Research Pricing for Trodusquemine
For laboratories and academic institutions, the cost of trodusquemine (MSI-1436) is readily available from specialized chemical suppliers. These prices reflect the cost of manufacturing small quantities for scientific investigation, rather than mass production for a pharmaceutical market. The following table provides a comparison of prices found from two different suppliers for research-grade trodusquemine.
Quantity | Supplier A Price | Supplier B Price | Price per mg (Supplier A) | Price per mg (Supplier B) |
---|---|---|---|---|
1 mg | $459.00 | N/A | $459.00 | N/A |
5 mg | $873.00 | $2,125.00 | $174.60 | $425.00 |
10 mg | $1,471.00 | $3,600.00 | $147.10 | $360.00 |
50 mg | $4,597.00 | $13,000.00 | $91.94 | $260.00 |
100 mg | N/A | $22,500.00 | N/A | $225.00 |
It is clear from this comparison that prices vary significantly between suppliers, emphasizing that this is not a product with a fixed market price. Bulk purchasing offers a lower price per milligram, a common practice in the research chemical industry.
The Unfinished Clinical Journey of Trodusquemine
The story of trodusquemine's clinical development is a key factor in its current status. It is a protein tyrosine phosphatase 1B (PTP1B) inhibitor that showed promise in preclinical studies and early-stage trials.
A timeline of development
- Early Promise: Preclinical studies showed potential for a wide range of therapeutic applications, including obesity, diabetes, and certain cancers. Trodusquemine's mechanism of action involves inhibiting PTP1B, which plays a role in regulating insulin signaling and other metabolic pathways.
- Phase I Trials: The compound progressed to Phase I clinical trials for conditions like obesity and type 2 diabetes. These studies examined safety, tolerability, and basic pharmacokinetic properties. While the results were largely positive, showing good tolerability, the original sponsoring company, Genaera, ran into financial difficulties.
- Development Halted: In 2009, Genaera ceased operations, halting the planned Phase II trials. The rights to trodusquemine were subsequently acquired by other companies, but development was not resumed in the same areas.
- Focus Shift to Newer Compounds: A spinout from Cold Spring Harbor Laboratory, DepYmed, acquired the rights to trodusquemine but decided to terminate further trials with the compound itself. Instead, they focused on developing a newer, more potent PTP1B inhibitor called DPM-1001.
This history explains why trodusquemine never reached the stage of commercialization, where a patient-facing price would be established. For further information on the background research, a detailed resource is available from the Alzheimer's Drug Discovery Foundation.
Factors That Determine the Cost of a Commercial Medication
For a drug to become a commercially available treatment with a set price for patients, it must navigate a long and expensive path, which trodusquemine did not complete. The price of an approved medication is determined by numerous factors, including:
- Research and Development (R&D) Costs: The billions of dollars spent on drug discovery, preclinical testing, and extensive clinical trials are factored into the final price. This includes failed candidates, as their costs are often amortized across successful drugs.
- Manufacturing and Production: Large-scale manufacturing for a commercial drug is a complex process with its own set of significant costs, including quality control, facility maintenance, and raw materials.
- Regulatory Fees: Obtaining and maintaining approval from bodies like the FDA requires substantial investment in fees, data submission, and post-market surveillance.
- Marketing and Distribution: Pharmaceutical companies invest heavily in marketing and building a robust distribution network to bring the drug to patients.
- Intellectual Property: Patent protection allows companies to recoup their R&D investments over a limited period by holding exclusive rights to the drug.
Conclusion: Trodusquemine Remains in the Lab
For those wondering about the cost of trodusquemine for treating a medical condition, the simple answer is that it is not available for that purpose. Trodusquemine's path to becoming a therapeutic drug was cut short, leaving it in the domain of scientific research. The prices quoted by chemical suppliers are for small, research-grade quantities and are not indicative of what a commercial treatment would cost. The clinical failures and financial hurdles of its original developers led to its stagnation, with the pharmaceutical industry now focusing on more potent PTP1B inhibitors. As a result, trodusquemine remains an interesting compound for researchers, but it offers no solution for patients seeking treatment.
Frequently Asked Questions
Is trodusquemine available to purchase for human use?
No, trodusquemine is not approved for human use and is only sold as a research chemical for laboratory purposes.
Why isn't trodusquemine available as a commercial drug?
Its clinical development was halted after initial Phase I trials when the original developing company, Genaera, faced financial difficulties and ceased operations.
What is the price of trodusquemine for researchers?
The cost varies depending on the supplier and quantity. Prices range from a few hundred dollars for one milligram to several thousands of dollars for larger research quantities.
What was trodusquemine being investigated for?
It was studied for its potential in treating obesity, type 2 diabetes, certain cancers, and neurodegenerative diseases due to its ability to inhibit the PTP1B enzyme.
Can I get trodusquemine from a doctor or pharmacy?
No, because it is not an approved medication, it cannot be prescribed by doctors or obtained from a pharmacy for patient use.
Are there newer drugs similar to trodusquemine?
Yes, a spinout company that acquired the rights to trodusquemine is now developing a successor PTP1B inhibitor named DPM-1001, which is reportedly more potent.
What is the clinical trial status of trodusquemine?
Phase I trials were completed, but the planned Phase II trials never took place due to the developer's financial issues, leaving its development in limbo.