Iran develops Tilmanocept radiopharmaceutical, set for commercialization by year-end

An Iranian knowledge-based company has developed Technetium-99m tilmanocept, a radiopharmaceutical used in cancer diagnosis, with the product expected to be commercialized by the end of the current Iranian calendar year (March 2027).

The domestically produced product is currently in the final stages of clinical trials and is expected to save Iran around $25 million in foreign currency, according to Dr. Seyyed Mohammad Shah-Cheragh, director of the company.

“Tilmanocept is one of the newest products developed by our company,” Shah-Cheragh said.

Technetium-99m tilmanocept, internationally marketed as Lymphoseek, is a radioactive diagnostic agent that accumulates in lymphatic tissue and helps doctors identify lymph nodes that drain a tumor.

It is used in lymphatic mapping and sentinel lymph node biopsy in several types of cancer.
Shah-Cheragh said the product had previously been exclusively produced by a US company since 2013.

“This product is the result of the efforts of the country’s young specialists after six months of research and work, and it was developed in the private sector,” he said.

According to Shah-Cheragh, the company produced the radiopharmaceutical about a year and a half ago and subsequently supplied it to the Atomic Energy Organization of Iran.

He said the company had faced difficulties obtaining even a single vial of the substance from abroad to use as a reference standard, forcing its researchers to develop the technology through reverse engineering.

“The path to reaching this point had many ups and downs. We could not even obtain a single vial of this substance from abroad as a reference standard,” he said.

“We were therefore forced to acquire the knowledge to produce this product through reverse engineering. Despite the various failures we experienced during the project, we eventually succeeded in achieving the appropriate final structure,” he added.

Shah-Cheragh said the domestically produced radiopharmaceutical would both facilitate cancer diagnosis and reduce the country’s reliance on imports.

“The product is in the final stages of clinical trials and will be commercialized by the end of this year and supplied to nuclear medicine centers,” he said.

As part of its efforts to expand domestic capabilities in nuclear medicine, Iran is also preparing to introduce AlphaZa, the country's first domestically developed alpha-emitting radiopharmaceutical for the treatment of advanced cancers that have become resistant to conventional therapies.

Mohammad Eslami, head of the Atomic Energy Organization of Iran (AEOI), announced in June that the drug is expected to enter the market in the near future, describing it as a significant achievement in Iran's nuclear medicine sector and a step toward expanding the country's capacity for targeted cancer treatment.

Eslami also said that 20 new radiopharmaceuticals are currently at the research and development stage and are expected to enter production during the current Iranian calendar year, further expanding Iran's domestic portfolio of nuclear medicine products.

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