Apitox, a purified injectable form of bee venom, is the lead candidate in Apimeds Pharmaceuticals US’s development pipeline — marking one of the few attempts to clinically advance venom-based therapies through the US regulatory pathway.
Composed of bioactive peptides like melittin and apamin, Apitox is being studied for its potential to address chronic pain and mobility loss in advanced knee osteoarthritis by targeting tissue-level inflammation.
On May 9, 2025, Apimeds began trading on the NYSE American under the ticker “APUS” following the close of its initial public offering (IPO). The company raised $13.5 million through the sale of 3.375 million shares at $4.00 each.
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Proceeds will support a new Phase III trial in knee osteoarthritis, sponsor-initiated research in multiple sclerosis (MS), manufacturing efforts and general operations.
Melittin and apamin have been studied for their ability to suppress pro-inflammatory cytokines such as TNF-alpha and IL-6. A peer-reviewed analysis in Frontiers in Nutrition reported that these peptides show anti-inflammatory and immunomodulatory activity in both preclinical and clinical studies, including in rheumatoid arthritis and MS.
Melittin, for example, modulates the NF-kappaB pathway, which is central to chronic inflammation. Clinical studies cited in the review reported symptom relief and improved inflammatory profiles in patients receiving controlled bee venom therapy.
While Apitox is not yet FDA-approved, a similar formulation known as Apitoxin has been used in South Korea since 2003 to manage osteoarthritis symptoms. Post-marketing safety data from over 3,000 patients showed no serious adverse events. However, a prior US Phase III trial led by Apimeds Korea did not meet FDA requirements due to a limited sample size and inadequate data handling.
Apimeds plans a new FDA-aligned trial in moderate to severe knee osteoarthritis and holds an active Investigational New Drug (IND) for Apitox in MS, transferred from its South Korean partner. Instead of advancing to late-stage trials, it will conduct early sponsor-led studies to assess Apitox’s role in MS symptom management. Preclinical data suggest that bee venom components may modulate immune responses linked to the disease.
Apimeds licenses its core technology from Apimeds Korea, a subsidiary of Inscobee Inc., which holds a majority ownership stake in the US entity. The company will use a lyophilized formulation for intradermal delivery, relying on manufacturing processes previously validated overseas. A future Biologics License Application (BLA) may be central to its US regulatory strategy.
Venom-Based Innovations in Modern Medicine
While historically seen only as toxic threats, several venoms have proven to contain highly selective peptides capable of modulating biological pathways involved in pain, inflammation, metabolism and cardiovascular health.
The Gila monster’s venom led to the first GLP-1 receptor agonist, exenatide, later paving the way for semaglutide (known under the brand names Ozempic and Wegovy).
Cone snail venom yielded ziconotide for chronic pain and is under study for rapid-acting insulin and new somatostatin-like peptides for pain relief and hormonal regulation.
From the funnel web spider, the peptide Hi1a has entered clinical trials for heart attack protection and donor heart viability.
Meanwhile, chlorotoxin from the deathstalker scorpion has been studied for tumor imaging and targeted delivery in glioblastoma, while shrew venom-derived peptides were researched for TRPV6-positive cancers like ovarian, breast and prostate.
Companies like AstraZeneca, Merck, Novartis and Bausch Health — alongside academic centers — are exploring venom-derived compounds from snakes, spiders, scorpions and bees for cardiovascular, neurological, oncologic and immunological applications.
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