Clinical Trial Application APPROVed
Green light on S072
Sea4Us’ first-in-class analgesic regulatory and ethical approval back S072’s promising efficacy with preclinical safety.
Clinical site activation took take place on April 30th 2026.
Sagres, Portugal, May 1st, 2026 – Sea4Us is a biotechnology company developing new marine leads for unmet clinical needs, and its lead project is a first in class analgesic for the treatment of chronic and acute pain.
Sea4Us today announces the achievement of a major milestone, with the approval of its clinical trial application (CTA) by regulatory authorities. Sea4Us will soon start First in Humans activities.
Strong preclinical safety and product profile back S072’s promising and superior efficacy when compared to the standards of care (e.g., opioids), are a critical step towards establishment of safety in humans (Phase 1 clinical trials).
Clinical Strategy for S072 starts with post-surgery medical indication, later to be expanded to chronic pain indications.
1st in class non-opiod analgesic
Our drug candidate, S072, is a small-molecule, inspired in a marine molecule and optimized for human health, that targets hyperactive peripheral neurons via selective modulation of key ion channels. This peripheral mechanism allows for potent analgesia without central nervous system side effects, eliminating risks of addiction, sedation, or cognitive impairment.
The drug candidate is intended for up to twice-daily oral dosing and has demonstrated an excellent safety profile during the GLP preclinical tests, with superior efficacy and duration of effect in head-to-head comparisons with the standards of care (e.g., morphine).
Pharmacokinetic studies show high oral bioavailability in preclinical species, elevated plasma exposure, low protein binding, and high hepatic stability in rats, dogs, and humans. Safety pharmacology indicates no significant CYP interactions, off-target effects, or behavioral toxicity. The compound is well tolerated, with a high safety margin. Robust efficacy proof-of-concept data has been generated across six validated animal models of disease, including post-operative pain, osteoarthritic pain, trigeminal neuralgia, chemotherapy-induced peripheral neuropathy, visceral pain/IBD, and monoarthritic pain.
Three patents have been submitted. Two are granted in the United States, and the third patent entered PCT in 2025 and was published in January 2026.
Clinical Strategy for S072 starts with post-surgery medical indication, later to be expanded to chronic pain indications.
Manufacturing Completed for Clinical Trials
S072 is a novel chemical entity (NCE) that is simple to synthesize chemically and highly stable.
Industrial up-scale is established, with both GLP and GMP certified qualifications and with high purity.
The Drug Substance for Clinical Trials has been manufactured with ongoing ICH-conform stability.
Drug Product is established as simple formulation. Clinical materials have been produced.
What is Chronic Pain, how widespread it is, and its implications are for individuals and society
If someone has persistent or recurring pain for more than three months, they are considered to have chronic pain. Chronic pain is regarded as a condition, rather than just an accompanying symptom. Various factors, including those of a biological, psychological, and social nature, contribute to this type of pain.
An estimated 100 million people in Europe and 1.6 billion worldwide suffer from chronic pain, which has been linked to depression, a higher suicide rate, as well as substance use and misuse. Chronic pain patients have limited quality of life, with a significant toll on an individual’s family and social relationships, and a higher likelihood of leaving the workforce – it costs Europe alone about €500 billion a year with similar numbers in the US.
There are medications available for the treatment of chronic pain, but many are either ineffective for certain types of pain and severity or, in the case of opioid drugs, have significant side effects, including the risk of addiction and dependence. This leaves patients and doctor with limited treatment options, if any, and always at the cost of safety or proper pain management.
More About Sea4Us
Sea4Us was launched in 2013 as a spin-off from NOVA University of Lisbon, with the mission to bring novel marine-inspired compounds to address unmet clinical needs, particularly those with ion channels as therapeutic targets.
Sea4Us’ unique approach combines marine biology and electrophysiology to open new avenues for a wide range of acute and chronic conditions. Sea4Us’ research and use are protected, with some patents already granted.
Sea4Us currently employs 20 people, and since its creation has raised 6.8M€ in private equity and grants.
