Denifanstat Achieved All Endpoints in the Treatment of Moderate to Severe Acne in Phase 3 Clinical Trial in Acne in China: A Presentation at the 2025 Fall Clinical Dermatology Conference
Sagimet (Nasdaq: SGMT) reported that denifanstat, a once-daily oral 50 mg FASN inhibitor, met all primary and secondary endpoints versus placebo in a Phase 3 randomized, double-blind, placebo-controlled trial in China enrolling 480 patients with moderate-to-severe acne (IGA 3–4) treated for 12 weeks. At Week 12, treatment success rates were more than double placebo with marked reductions in inflammatory and non-inflammatory lesions. Denifanstat was generally well tolerated. Ascletis completed a pre-NDA consultation with China NMPA and plans to submit an NDA soon. Trial data will be presented at the 2025 Fall Clinical Dermatology Conference (Oct 24–26) in Las Vegas.
Sagimet (Nasdaq: SGMT) ha riferito che denifanstat, un inibitore FASN orale una volta al giorno da 50 mg, ha raggiunto tutti gli endpoint primari e secondari rispetto al placebo in uno studio di fase 3 randomizzato, in doppio cieco, controllato con placebo, in Cina che ha arruolato 480 pazienti con acne da moderata a grave (IGA 3–4) trattati per 12 settimane. Alla settimana 12, i tassi di successo del trattamento erano più che raddoppiati rispetto al placebo con marcate riduzioni delle lesioni infiammatorie e non infiammatorie. Denifanstat è stato generalmente ben tollerato. Ascletis ha completato una consultazione pre-NDA con la NMPA cinese e prevede di presentare presto una NDA. I dati dello studio saranno presentati al 2025 Fall Clinical Dermatology Conference (24–26 ottobre) a Las Vegas.
Sagimet (Nasdaq: SGMT) informó que denifanstat, un inhibidor FASN oral de 50 mg una vez al día, cumplió todos los endpoints primarios y secundarios frente a placebo en un ensayo aleatorizado de fase 3, doble ciego, controlado con placebo, en China que incluyó a 480 pacientes con acné moderado a severo (IGA 3–4) tratados durante 12 semanas. En la semana 12, las tasas de éxito del tratamiento fueron más del doble que placebo, con reducciones marcadas en lesiones inflamatorias y no inflamatorias. Denifanstat fue generalmente bien tolerado. Ascletis completó una consulta pre-NDA con la NMPA china y planea presentar una NDA pronto. Los datos del ensayo se presentarán en la Clinical Dermatology Conference de otoño 2025 (del 24 al 26 de octubre) en Las Vegas.
Sagimet (나스닥: SGMT)는 매일 한 번 복용하는 경구 FASN 억제제 denifanstat가 중국에서 12주 동안 중등도에서 중등도-심한 여드름(IGA 3–4)을 가진 480명의 환자를 대상으로 한 무작위, 이중맹검, 위약대조 3상 임상시험에서 주요 및 보조 1차 종결점를 충족했다고 발표했습니다. 12주 차에 치료 성공률은 위약보다 두 배 이상이었고, 염증성 및 비염증성 병변이 크게 감소했습니다. Denifanstat는 대체로 내약성이 양호했습니다. Ascletis는 중국 국가약감사국(NMPA)과의 NDA 사전 상담을 완료했고 곧 NDA를 제출할 계획입니다. 임상 데이터는 2025년 가을 피부과학 학술대회(10월 24-26일)에서 라스베가스에서 발표될 예정입니다.
Sagimet (Nasdaq : SGMT) a rapporté que le denifanstat, un inhibiteur FASN oral à dose unique de 50 mg, a atteint tous les critères primaires et secondaires par rapport au placebo dans un essai de phase 3 randomisé, en double aveugle, contrôlé par placebo, en Chine et ayant recruté 480 patients présentant une acné modérée à sévère (IGA 3–4) traités pendant 12 semaines. À la semaine 12, les taux de réussite du traitement étaient plus du double que le placebo, avec des réductions marquées des lésions inflammatoires et non inflammatoires. Le denifanstat a été généralement bien toléré. Ascletis a terminé une consultation pré-NDA avec la NMPA chinoise et prévoit de soumettre un NDA prochainement. Les données de l’essai seront présentées à la conférence Clinical Dermatology d’automne 2025 (du 24 au 26 octobre) à Las Vegas.
Sagimet (Nasdaq: SGMT) berichtete, dass Denifanstat, ein einmal täglich oral verabreichtes 50 mg FASN-Inhibitor, alle primären und sekundären Endpunkte im Vergleich zu Placebo in einer randomisierten, doppelblinden, placebokontrollierten Phase-3-Studie in China erfüllt hat, bei der 480 Patienten mit mittelschwerer bis schwerer Akne (IGA 3–4) behandelt wurden über 12 Wochen. In Woche 12 lagen die Behandlungserfolgsraten mehr als doppelt so hoch wie Placebo, mit deutlichen Reduktionen entzündlicher und nicht entzündlicher Läsionen. Denifanstat wurde allgemein gut vertragen. Ascletis hat eine Pre-NDA-Beratung mit der chinesischen NMPA abgeschlossen und plant, demnächst ein NDA einzureichen. Studiendaten werden auf der Herbst-Clinical-Dermatology-Konferenz 2025 (24.–26. Oktober) in Las Vegas vorgestellt.
ساجيميت (ناسداك: SGMT) أبلغت أن denifanstat، وهو مثبط FASN فموي مرة واحدة يوميًا بجرعة 50 ملغ، حقق جميع النقاط الأساسية والثانوية مقابل الدواء الوهمي في تجربة عشوائية من المرحلة 3 مزدوجة التعمية ومُقارنة بالدواء الوهمي في الصين وشملت 480 مريضًا بعُدّ حب الشباب من المتوسط إلى الشديد (IGA 3–4) لمدة 12 أسبوعًا. في الأسبوع 12، كانت نسب نجاح العلاج أكثر من الضعف مقارنة بالدواء الوهمي، مع تخفيضات كبيرة في الآفات الالتهابية وغير الالتهابية. كان تحمل Denifanstat عامًا جيدًا بشكل عام. أتمت Ascletis استشارة ما قبل NDA مع NMPA الصينية وتخطط لتقديم NDA قريبًا. ستُعرض بيانات التجربة في مؤتمر Clinical Dermatology الخريفي 2025 (24–26 أكتوبر) في لاس فيغاس.
Sagimet（纳斯达克：SGMT） 报告称，denifanstat，一日一次口服的 50 mg FASN 抑制剂，在中国进行的第三阶段随机、双盲、安慰剂对照试验中，招募了 480 例患者，患有中度至重度痤疮（IGA 3–4），治疗 12 周，相比安慰剂的治疗成功率超过两倍，炎性及非炎性病变均显著下降。Denifanstat 的耐受性总体良好。Ascletis 已完成与中国药监局的 NDA 前咨询，计划尽快提交 NDA。试验数据将于 2025 年秋季皮肤病学大会（10 月 24–26 日）在拉斯维加斯公布。
- Phase 3 trial enrolled 480 patients
- Met all primary and secondary endpoints at Week 12
- Treatment success >2x placebo at Week 12
- Completed pre-NDA consultation with China NMPA
- Ascletis plans to submit NDA soon
- None.
Insights
Phase 3 met all endpoints in China; strong efficacy and tolerability signal supports regulatory filing.
In a randomized, double-blind, placebo-controlled Phase 3 trial in China, denifanstat 50mg once daily (n=480 randomized 1:1) achieved all primary and secondary endpoints at
Safety was reported as "generally well tolerated," which, coupled with clear efficacy, supports regulatory advancement. Key internal dependencies remain the full dataset details (absolute rates, confidence intervals, adverse event types and severities) that regulators will scrutinize during the NDA review. The trial duration was
Watch for the
Positive regulatory trajectory in China with imminent NDA plan; commercial potential hinges on safety profile and label scope.
Ascletis completed a pre-NDA consultation with the NMPA and plans to submit an NDA soon for denifanstat in moderate-to-severe acne, which follows the Phase 3 success. A successful NDA submission could lead to a review clock and potential approval timeline driven by the completeness of efficacy and safety data presented in the trial (n=480, 12-week treatment).
Commercial prospects depend on the final label (indication severity, age limits, and safety warnings) and how the tolerability profile compares to existing options. The announcement cites treatment success rates more than double placebo and marked lesion reductions; regulators will weigh those efficacy magnitudes against any identified risks. Monitor the NDA submission date and any regulatory questions or requests for additional data over the next
Denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated in a Phase 3 clinical trial in acne in China conducted by license partner Ascletis
Ascletis announced completion of its pre-NDA consultation with China’s NMPA and its plans to submit an NDA for denifanstat in China
SAN MATEO, Calif., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported that data from a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), will be presented at the 2025 Fall Clinical Dermatology Conference taking place October 24-26, 2025, in Las Vegas, Nevada. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of world.
The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne, defined as Investigator’s Global Assessment (IGA) scores of 3 and 4. This trial enrolled 480 patients who were randomized 1:1 into two treatment arms to receive denifanstat 50mg or placebo, once daily for 12 weeks. Primary endpoints included the percentage of treatment success (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline), the percentage change in total lesion count, and the percentage change in inflammatory lesion count. Denifanstat met all primary and secondary endpoints and was generally well tolerated.
In October, Ascletis announced that it completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon.
2025 Fall Clinical Dermatology Conference Poster Presentation Details:
| Title: | FASN Inhibitor Denifanstat Achieved All Endpoints in the Treatment of Acne Vulgaris: Results from a Phase III Randomised Placebo-Controlled Trial |
| Presenting authors: | Neal Bhatia, MD, FAAD, Director of Clinical Dermatology at Therapeutics Clinical Research, Kearny Mesa, San Diego, CA Leon H. Kircik, MD, FAAD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY; Adjunct Clinical Professor of Dermatology, Indiana University School of Medicine, Indianapolis, IN; Medical Director, Physicians Skin Care, PLLC and DermResearch, PLLC, Louisville, KY |
| Date/Time: | October 25 - 26, 2025 |
| Location: | The Wynn Hotel, Las Vegas, Nevada |
Key Presentation Highlights: Once daily oral 50 mg denifanstat achieved highly statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints when analyzed using an intent-to-treat (ITT) analysis. At Week 12, treatment success rates with denifanstat were more than double those of placebo, with marked reductions in both inflammatory and non-inflammatory lesions. Denifanstat was generally well-tolerated.
“Denifanstat’s Phase 3 results in acne demonstrate FASN inhibition’s potential as a novel mechanism of action for the treatment of acne, a condition that impacts more than 50 million people in the U.S. annually and has seen limited innovation over the past 40 years,” said David Happel, Chief Executive Officer of Sagimet. “In June 2025, we initiated a Phase 1 first-in-human clinical trial with a second FASN inhibitor, TVB-3567, that we plan to develop for patients with moderate to severe acne.”
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 pharmacokinetic (PK) clinical trial of a combination of denifanstat and resmetirom that is planned to be developed for patients living with MASH. Sagimet has also initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne for the U.S. For additional information about Sagimet, please visit www.sagimet.com.
About Acne
There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated
- Bickers DR, et al. J Am Acad Dermatol. 2006;55(3):490-500.
- American Academy of Dermatology. Burden of Skin Disease. 2017. www.aad.org/BSD.
- Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies Sagimet may develop; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
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LifeSci Advisors
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FAQ
What were the key Phase 3 denifanstat results reported on October 24, 2025 for SGMT?
What dose and treatment duration were used in the SGMT/Ascletis Phase 3 acne trial?
Does SGMT/Ascletis plan regulatory filing in China after the Phase 3 acne results?
When and where will SGMT present the denifanstat Phase 3 acne data?
What safety profile was reported for denifanstat in the Phase 3 acne trial?
