Alteogen is applying for a global phase 2 clinical trial ( IND ) for먹튀검증 ‘ ALT-P1 ’, a long-acting growth hormone administered once a week, in India this month. If all goes according to schedule, the product is expected to be launched around 2027. According to Alteogen on the 15th, it plans to apply for a global phase 2 IND for ‘ ALT-P1 ‘ to the Indian authorities as early as this month. It has been a year since the company announced that it would directly conduct phase 2 ALT-P1 at the request of a partner company with which it signed a technology transfer agreement last year . The long-acting growth hormone developed by Alteogen has completed phase 1 clinical trials in Korea and India, and signed a technology transfer agreement for joint development of ALT-P1 with Cristalia, Brazil in 2019. Crystallia holds the copyright for ALT-P1 in South America. The global phase 2 clinical trial for long-acting growth hormone will be conducted directly by Alteogen, and the clinical cost, which is expected to be approximately 50 billion won, will be borne by Crystallia. Alteogen announced that it planned to apply for IND after completing the production of related test drugs last year , but it was delayed due to changes in the contract research organization ( CRO ) of its partner company . Once the clinical trial is approved, it is expected to enter phase 2 next year. Eugene Investment & Securities predicted that the product could be launched in 2027 if product development proceeds according to schedule. Long-acting growth hormone is a treatment for growth hormone deficiency in children and adults. According to Presence Research, a global market research firm, the global growth hormone market is expected to grow at an average annual rate of 8% from $4.86 billion last year to $10.87 billion in 2032. As of 2021, the United States accounts for 40% of the global market. The domestic market has grown at an average annual growth rate of more than 20% over the past five years, reaching a size of 250 billion won as of last year. Existing growth hormone treatments required subcutaneous injection once a day, 6 to 7 times a week. To increase convenience, global companies have focused on developing long-acting growth hormones that are administered once a week. Skytropa, which was first launched in 2022 as a once-a-week formulation, recorded sales of about $40 million (about 50 billion won) in the first year of launch. At the end of June this year, Pfizer’s Angela received approval from the U.S. Food and Drug Administration ( FDA ). In addition to Angela, the pipeline that has received FDA approval or is undergoing clinical trials is the Novo Nordisk pipeline (phase 3 clinical trials in progress). When Alteogen launches its product, it is expected to become the fourth globally. The South American copyright belongs to Crystallia, but the rights to major markets such as the US, Europe, China, and Japan are still held by Alteogen. A technology transfer agreement is possible in the future.
Alteogen, global phase 2 clinical trial for ‘once-weekly administration growth hormone’ to begin soon
