ENVALITH
株式会社メドレックス logo

Medrx Co.,Ltd.

4586Growth MarketPharmaceuticals

株式会社メドレックス logo
Medrx Co.,Ltd.4586

Business

Medrx Co., Ltd. is a drug discovery corporate group that develops pharmaceuticals with new added value by turning into transdermal patches drugs for which transdermal absorption has traditionally been difficult, based on its proprietary ionic-liquid-utilizing transdermal absorption formulation technologies ILTS® and NCTS®. Founded in 2002 in Higashikagawa City, Kagawa Prefecture, the company listed on the Tokyo Stock Exchange Mothers market (now the Growth Market) in 2013. The group consists of three companies—the Company, MEDRX USA INC., and MEDRX AUSTRALIA PTY LTD—and is conducting clinical development in the United States and Australia on multiple transdermal patch pipeline candidates targeting pain, spastic paralysis, central nervous system disorders, and other conditions. In September 2025, Bondlido (MRX-5LBT), a treatment for postherpetic neuralgia, received marketing approval from the US FDA, and the company plans to launch it in the second half of FY2026 (ending March 2026) as its first product in the United States. The company operates as a small organization with 16 R&D personnel and 21 employees in total.

Business Model

The Company creates pharmaceutical candidate formulations using its proprietary formulation technology, enhances the value of development assets through nonclinical and clinical trials, and then enters into partnership agreements with pharmaceutical companies and others. Revenue is earned in the form of "upfront contract fees and milestone fees based on development progress" and "royalties linked to post-launch product sales." All manufacturing is outsourced externally (fabless), enabling management resources to be concentrated on research and development. Of the ¥128 million in net sales for FY2025 (ending December 2025), the breakdown consists of ¥100 million (78.1%) in milestone income from DWTI, ¥24 million (18.8%) in R&D-related income from Alto, and others, with revenue dependent on the development progress of the pipeline.

Company Strengths

Developed the world's first ILTS® technology, which dramatically improves transdermal permeability by converting drugs into ionic liquids and dissolving them. The company has accumulated a highly safe ionic liquid library, know-how for selecting optimal ionic liquids, and formulation know-how, and has a track record of application to a wide range of drugs from small molecules to macromolecules.

Bondlido (MRX-5LBT) received marketing approval from the US FDA in September 2025 for the indication of postherpetic neuralgia in adults. Using the net sales of the preceding competing product ZTlido, which were approximately ¥8.0 billion equivalent (USD 52 million) in 2024, as a benchmark, the company is proceeding with partnership negotiations with sales partners and plans to launch the product in the second half of FY2026 (ending March 2026).

As of the end of the fiscal year ending December 2025, the equity ratio was 92.2%, and cash and cash equivalents stood at ¥1,754 million. The company secured financing income of ¥739 million through the exercise of the 32nd series of stock acquisition rights, and has already secured funds for near-term development and working capital needs. Total liabilities were extremely low at ¥108 million, indicating a high level of financial soundness.

ENVALITH's Perspective

In May 2026, the company entered into a legally binding term sheet with Terrain Pharmaceuticals, and preparations for launch in the second half of 2026 are underway. The peak net sales of the leading competing product, ZTlido, are said to be approximately 52 million USD (2024), which is expected to serve as a benchmark for market penetration. However, it should be noted that the detailed terms of the sales license agreement are currently under negotiation, and the specific scale of revenue contribution, such as upfront payments and royalty rates, remains undetermined.

A Phase 2 proof-of-concept (POC) trial targeting patients with spasticity due to multiple sclerosis is ongoing, with top-line results expected in Q4 2026. The US muscle relaxant market is estimated at approximately 1,743 million USD in 2025, and the product is positioned as a potential blockbuster candidate in the absence of any existing transdermal formulation. Whether POC is achieved will have a major impact on the progress of out-licensing negotiations and on enterprise value, making the trial results the most important item to monitor.

In April 2026, top-line results were obtained from the Phase 2 proof-of-concept (POC) trial of Alto-101 in patients with schizophrenia, but statistical significance was not achieved on the primary endpoint (EEG theta band index) (p=0.052). Alto has announced that it will prioritize resource allocation to Alto-207 going forward, and will not independently develop Alto-101 but will instead explore strategic partnership opportunities. On the other hand, selling, general and administrative expenses in Q1 2026 were significantly reduced to ¥251 million from ¥420 million in the same period of the previous year, and this improvement in cost control can be positively evaluated.

Growth Strategy

Monetization through Bondlido launch and MRX-4TZT Phase 2 success leading to licensing revenue, alongside diversified pipeline development

In May 2026, the company entered into a legally binding term sheet with Terrain Pharmaceuticals regarding a sales partnership. The company is currently working with Terrain to finalize the detailed terms of the sales license agreement while preparing for launch in the second half of 2026. The company aims for market penetration benchmarked against the peak net sales of the leading competitor product, ZTlido.

A Phase 2 POC clinical trial in patients with spasticity due to multiple sclerosis is ongoing. Through proof of concept demonstrating "improved safety and tolerability while maintaining efficacy," the company aims to advance licensing-out negotiations and enhance corporate value as a blockbuster candidate.

FDA Fast Track designation has already been obtained. Through value enhancement via misuse and accident prevention features, the company intends to displace and further expand the U.S. fentanyl patch market, estimated at approximately 125 million US dollars in 2025. Comparative clinical trials against the reference product and verification testing of the misuse prevention feature are being planned.

In the Phase 2 POC clinical trial in April 2026, statistical significance on the primary endpoint was not achieved. Alto has indicated a policy of exploring strategic partnership opportunities rather than pursuing independent development. The company plans to conduct a detailed analysis of the trial results together with Alto and determine its policy, including the possibility of formulation improvements.

The company operates one of only a few Microneedle clinical trial drug manufacturing facilities in the world for pharmaceutical and vaccine applications. In parallel with technology development for mass production, the company is exploring business partnerships while conducting feasibility studies using animal models.

Last updated: July 17, 2026