Shaperon pivots NuGel to steroid combo after solo trial falls short in atopic dermatitis
NuGel, Shaperon's topical drug for atopic dermatitis, hit a wall in clinical trials. The company had hoped NuGel alone would stand out, but the numbers told a different story. After phase 2 trials in Korea and the US with 208 patients, NuGel failed to beat placebo on the main measure: the Eczema Area and Severity Index (EASI). The placebo group did better than expected, upending Shaperon's original plan. Instead of pulling back, the company looked at the secondary results and changed course fast. According to an EDaily clinical trial report, Shaperon got the final phase 2 data on October 1, 2026. The results confirmed NuGel did not show a statistically significant edge over placebo for the main outcome.
In the NuGel 2% group, 39.2% of patients reported significant itch improvement after 4 weeks, compared to 20.8% in the placebo group-a statistically significant difference.
Why Shaperon is betting on combination therapy
Atopic dermatitis rarely goes away for good, so long-term control is what matters. Steroids are still the go-to treatment, but doctors limit them to short bursts-usually no more than four weeks-because of side effects. Shaperon's CEO, Sung Seung-yong, says patients need something they can use safely for months, not just weeks. NuGel was designed to target the GPCR19 receptor in immune cells and calm inflammation at its source. Now, Shaperon thinks pairing NuGel with steroids could help stop the rebound flare-ups that often hit after steroids are stopped, making it safer to keep symptoms in check over time.
The new plan is to use NuGel with steroids for two to four weeks, then switch to NuGel alone to keep the disease from coming back. Hundreds of trial patients had no serious side effects with NuGel, which backs up its safety for longer use. In the second part of the phase 2 trial, 23.2% of patients in the NuGel 1% group hit the mark on the validated Investigator Global Assessment (vIGA) scale after four weeks, compared to 9.4% in the placebo group. But this difference just missed statistical significance (p=0.053), as detailed in the EDaily trial summary.
Market ambitions and next steps
The global market for first-line atopic dermatitis drugs-mostly steroids-sits between 10 trillion and 13 trillion won. Shaperon wants NuGel to break into this market, not as a steroid substitute, but as a partner that could let patients use steroids more safely for longer. The company is also chasing global tech transfer deals and plans to put future earnings into developing an oral atopic dermatitis drug and a next-generation "nanobody" antibody therapy.
Shaperon has stated that, based on NuGel's safety profile and certain efficacy signals, it will shift its development program: after a short steroid course, NuGel is planned as a maintenance therapy.
CEO Sung Seung-yong puts it plainly: "We aim to develop NuGel as a drug that can be used together with first-line therapy from the outset." He warns patients not to fear steroids, pointing out their value when used right and the risks of stopping them without a doctor's advice. Shaperon is not trying to get rid of steroids, but to make it possible for patients to use them more safely and for longer stretches when needed.
This shift shows how a biotech can regroup after a clinical setback and still move forward. By doubling down on combination therapy, Shaperon is keeping NuGel in play and tackling the real-world need for safer, longer-term atopic dermatitis treatment. The company says it will talk with partners about more studies and is still looking for an international licensing deal. For now, there is no outside confirmation of regulatory approval or a commercial launch for NuGel.
