A Phase II/III Seamless Design, Randomized, Double-blind, Paralleled-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers

This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers. The primary endpoint is the proportion of subjects with complete closure of target ulcer during the 16-week treatment phase.

Start Date16 Aug 2024

Sponsor / Collaborator

Oneness Biotech Co., Ltd.

IRCT20161108030776N5

/ CompletedPhase 3IIT

The effect of Centella asiatica L. on cognitive impairments in patients with multiple sclerosis (MS)

Start Date06 Aug 2022

Sponsor / Collaborator

Kerman Medical University

NCT05438251

/ TerminatedPhase 4

Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)

A Research Study to evaluate the therapeutic effect of Fespixon cream in patients suffering from DFU (UTWCS Grade III-A or III-B) by measuring the change of grade of UTWCS (University of Texas Diabetic Wound Classification system), wound area reduction, infection control, and incidence of treatment-emergent adverse event (TEAE).

Start Date04 Aug 2022

Sponsor / Collaborator

Oneness Biotech Co., Ltd.

[+1]

100 Clinical Results associated with Plectranthus amboinicus/Centella Asiatica cream(Oneness Biotech)

100 Translational Medicine associated with Plectranthus amboinicus/Centella Asiatica cream(Oneness Biotech)

100 Patents (Medical) associated with Plectranthus amboinicus/Centella Asiatica cream(Oneness Biotech)

Literatures (Medical) associated with Plectranthus amboinicus/Centella Asiatica cream(Oneness Biotech)

01 Jan 2026·MAYO CLINIC PROCEEDINGS

Real-World Effectiveness and Dose-Response of ON101 Therapy for Healing of Diabetic Foot Ulcers

Article

Author: Chang, Jung-Hsuan ; Chang, Hao-Chin ; Yang, Chen-Yi ; Chang, Shun-Cheng ; Lin, Xin-Yi ; Ou, Huang-Tz ; Tsai, Feng-Chou ; Cheng, Nai-Chen ; Huang, Ching-Uen ; Wu, Yi-Chun ; Chiu, Yu-Fen

OBJECTIVE:

To evaluate the real-world effectiveness and dose-response of ON101 , especially for high-risk patients with poor healing outcomes.

PATIENTS AND METHODS:

ON101 cream, a novel treatment for diabetic foot ulcers (DFUs), modulates the function of macrophages and accelerates the emergence and expansion of anti-inflammatory properties. In this study, 80 and 98 patients with DFU who were treated using ON101 and standard care with adjuvant therapy (denoted as nonuse), respectively, from January 1, 2020, to December 31, 2022, were identified from Taipei Medical University-Shuang Ho Hospital, Taiwan. The primary outcome was a complete healing event within 120 days following treatment initiation. Secondary outcomes included ulcer recurrence, amputation, and all-cause mortality within 1 year of follow-up. Cox proportional hazard model analysis was applied to determine the treatment effect on study outcomes. The dose-response of ON101 on healing outcomes was modeled using a regression analysis.

RESULTS:

Compared with nonuse, ON101 use significantly increased the complete healing outcome by 79% (HR, 1.79; 95% CI, 1.24 to 2.58), with an average of 1.85 ON101 tubes used per person with healed ulcers. Favorable healing outcomes were consistently shown in the analyses of high-risk patients. The dose-response analysis results suggest 25%, 107%, 33%, and 19% decreases in the ulcer size per additional ON101 tube use for all study patients and those with Wagner grade 1, 2, and 3 ulcers, respectively (all P<.01).

CONCLUSION:

Promising healing outcomes following ON101 therapy at lower doses among real-world patients with DFU are corroborated, with a potential therapeutic benefit for clinically disadvantaged patients and practical feasibility for use in routine practice.

01 Aug 2025·Journal of Wound Care

Enhancing diabetic foot wound healing with topical macrophage-regulating cream (ON101): a case series.

Article

Author: Huang, Shu-Hung ; Kuo, Yur-Ren ; Wu, Yi-Chia ; Ng, Kwan Lok Benjamin ; Lee, Su-Shin ; Chen, Rong-Fu ; Lin, Yun-Nan ; Chen, Wei-Yu

OBJECTIVE:

A number of treatments have been developed to treat hard-to-heal (chronic) diabetic foot ulcers (DFUs). This case series the use of ON101-a new topical macrophage regulatory cream for the treatment of DFUs, that helped achieve limb-salvage outcomes with an adequate safety profile.

METHOD:

Patients with hard-to-heal DFUs-primarily on the toes and plantar surfaces-were enrolled in the study. After infection control, wound debridement or angioplasty intervention, ON101, containing 1.25% extracts of Plectranthus amboinicus (0.25%) and Centella asiatica (1%), was applied topically to the wounds up to twice daily. The condition of the wounds, complications, healing progression and other details were documented.

RESULTS:

In total, 10 patients, with a mean age of 59.2 years (range: 35-77 years), were included in the study following surgical debridement, sequestrectomy or revascularisation. Wound sizes ranged from 1-66 cm². After receiving ON101 treatment for durations ranging from 14-264 days, most wounds healed without complications, except for one patient with osteomyelitis who did not fully recover. All patients expressed satisfaction with the outcomes and had no reported complications at the six-month follow-up.

CONCLUSION:

This case series demonstrated the real-world outcomes of ON101, which exhibited good healing efficacy in the treatment of DFUs, making it a promising strategy for the topical treatment of these ulcers.

01 Aug 2025·DIABETES OBESITY & METABOLISM

Cost‐effectiveness of ON101 with general wound care for diabetic foot ulcers among patients with type 2 diabetes in Singapore: Analysis of a multi‐ethnic country in Asia

Article

Author: Chew, Khong‐Yik ; Graves, Nicholas ; Su, Hsuan‐Yu ; Ou, Huang‐Tz

Abstract:

Aims:

Diabetic foot ulcers (DFUs) impose a vast health and economic burden on individuals and healthcare systems globally. We assessed the cost‐effectiveness of adding ON101, a novel treatment for accelerating wound healing, to general wound care (GWC) versus GWC alone for DFUs in Singapore, a multi‐ethnic country with increasing DFU prevalence in a growing type 2 diabetes population.

Materials and Methods:

A Markov model was utilized to estimate the healthcare costs and quality‐adjusted life years (QALYs) over 5 years from a healthcare sector perspective. Model inputs were mainly derived from the Singapore Wound Registry and published literature. The primary outcome was the incremental cost‐effectiveness ratio (ICER). Subgroup analyses stratified by clinically important DFU conditions and scenario analyses were conducted to confirm the study's robustness.

Results:

Compared to GWC alone, adding ON101 yielded greater QALY gained (i.e., 0.15) and lower healthcare costs (i.e., −US$16237) for patients with DFUs. Remarkable cost‐savings from the use of ON101 with GWC were observed for patients with complex DFUs, namely ICERs of −US$161 963, −US$181 726 and −US$199 130 per QALY gained for cases with HbA1c ≥ 9%, ulcer duration >6 months and ulcer size >5 cm 2 , respectively. Scenario analysis comparing ON101 with GWC to negative pressure wound therapy with GWC yielded an ICER of −US$677 243 per QALY gained.

Conclusions:

Combining ON101 with GWC versus GWC alone was highly cost‐effective for DFUs in Singapore. Also, the economic results for complex DFU cases underscore the value of ON101 in addressing DFU treatment challenges for managing complex cases, offering cost‐savings alongside clinical benefits.

News (Medical) associated with Plectranthus amboinicus/Centella Asiatica cream(Oneness Biotech)

10 Sep 2024

·www.prnewswire.com

Pan-COVID New Drug - SNS812 Achieves Superiority in Phase 2 Study

CUPERTINO, Calif., Sept. 10, 2024 /PRNewswire/ -- Oneness Biotech and Microbio (Shanghai) announced that the pan-COVID New Drug, SNS812, co-developed by both companies achieves statistical significance with clinically meaningful endpoints in the Phase 2 trial. SNS812 has demonstrated good safety and efficacy in treating various virus strains including the currently prevalent strain JN.1 and many high immune-escape variants. Continue Reading Oneness Biotech and Microbio (Shanghai) announced that the pan-COVID New Drug, SNS812, co-developed by both companies achieves statistical significance with clinically meaningful endpoints in the Phase 2 trial. SNS812 is the only therapeutic with a broad-spectrum efficacy in multiple coronavirus variants. It has much more clinical advantages compared with Paxlovid, a Pfizer's drug with 70% market share. Dr. Shuling Cheng, the President of Oneness Biotech commented that this randomized, double-blind, placebo-controlled study was conducted at the National Taiwan University Hospital and 3 hospitals affiliated with Taipei Medical University (TMUH, Shuangho Hospital, and Wangfang Hospital) in compliance with the FDA's requirements. There were 3 cohorts with SNS812 200mg, SNS812 100mg and placebo respectively with a total of 135 subjects; 45 subjects in each group. The study results demonstrate that SNS812 inhalation was well supported by clean safety profile without any drug-related adverse events. Compared with the placebo group, SNS812 group achieves statistical significance in all target symptoms related to COVID-19 infection, including the time to sustained alleviation and resolution of fever, sore throat, shivers, headache, shortness of breath, nausea, vomiting, loss of smell and taste (P=0.007). The study results suggest a better outcome than other therapeutics in the global market. Dr. Shuling Cheng also points out that the genomic sequencing of the virus strains from all subjects demonstrates coverage of the latest prevalent genotypes, including JN.1, KP1-4, LB.1, BA.2, and XBB variants with 90% high immune-escape variants (JN.1、KP1-4 & LB.1). This also demonstrates that SNS812 is the only up-to-date COVID-19 new drug with broad-spectrum efficacy in the world. Dr. Yi-Chung Chang, the President of Microbio (Shanghai) commented that SNS812 treatment group achieves viral-negative earlier than the placebo group (P=0.018). The median time to achieve viral-negative in SNS812 200mg group was 2.9 days. SNS812 also significantly improved the loss of smell and taste related to the CNS system. Compared with the placebo group, SNS812 shows superior efficacy in alleviating or resolving the symptoms, including shortness of breath, fever, shivers, etc., which usually lead to severe COVID-19. Dr. Chang further explained that the current marketed COVID-19 therapeutics have side effects and the vaccines under development are lagged behind the evolution of the variants, which will not be effective. The SNS812 study readout is not only a great success for Oneness Biotech and Microbio (Shanghai), but also a worldwide medical breakthrough. According to the COVID-19 variants data published by the Centers for Disease Control and Prevention (CDC), new variants almost emerge every three months. Vaccine development falls behind the viral mutation. The U.S. government has initiated a project to incentivize the development of new therapies to address the issue of COVID-19 mutation variants. Globally, there is an urgent need for breakthrough solution to effectively treat or prevent the COVID-19 outbreak to the humanity. About Oneness Biotech Co., Ltd. (4743.TWO) Oneness Biotech was established in 2008 and went public in 2011. Oneness has been dedicated to research and development of game changing treatments and its key pipelines include Fespixon® new drug and Bonvadis® medical device for chronic wounds, FB825, the Anti-IgE B cells mAb out-licensed to global pharma for US$530 mn, and SNS812, the pan-COVID siRNA new drug of which phase 2 study achieves significant efficacy outcome. Oneness is committed to ESG and has been selected as an index component of the Dow Jones Sustainability Emerging Markets Index, included in the S&P Sustainability Yearbook 2023 and 2024, etc. It is also the only biotech company in Taiwan that received such ESG achievements. About Microbio (Shanghai) Co., Ltd. Microbio (Shanghai) is the subsidiary of Microbio Co., Ltd. in Taiwan and is also an important footprint in China for Microbio Group's. Microbio (Shanghai) has established its own core technology in nucleic acid new drugs by targeting viruses and bacteria. Multiple new drugs with first-in-class targets are under pre-clinical and clinical development. One of the breakthrough new drugs developed from this platform technology is SNS812, the pan- COVID siRNA new drug of which the phase 2 study achieves significant efficacy outcome with clean safety profile. With the success in the clinical trial, Global partnership will be the strategy for the next stage of SNS812's development. View the video for Pan-COVID New Drug – SNS812 Achieves Superiority in Phase 2 Study SOURCE Oneness Biotech

Phase 2Vaccine

16 Nov 2023

·www.prnewswire.com

Innovative Researcher Ben Zimmerman Awarded Grant to Propel Aging-Related Research

PORTLAND, Ore., Nov. 16, 2023 /PRNewswire/ -- Ben Zimmerman, Ph.D., a postdoctoral researcher investigator at the Helfgott Research Institute at the National University of Natural Medicine, has received a grant from the Medical Research Foundation (MRF) to advance the understanding of aging-related health. This grant investigates natural medicine interventions and mechanisms for delaying or preventing age-related cognitive decline and dementia. Zimmerman's research project centers on the study of Centella asiatica, also known as gotu kola, and its potential impact on the vascular health of healthy adults between 50 and 85. The research will investigate whether a four-week treatment with Centella asiatica can enhance peripheral arterial endothelial function, an indicator of vascular health. Most studies tend to focus on cognitive interventions or pharmaceutical treatments for dementia. Dr. Zimmerman's approach, centered on vascular health and a traditional herbal remedy, is a refreshing departure from conventional avenues of research. This study plans to enroll 30 participants, half receiving the Centella asiatica treatment while the other half receives a placebo. The primary outcome measure will focus on the Reactive Hyperemia Index (RHI), an indicator of the body's ability to regulate arterial blood flow—a fundamental element of vascular health. Maintaining normal or improving peripheral arterial endothelial function may be a crucial defense against the vascular mechanisms of cognitive aging. It may pave the way for more targeted and effective interventions to delay or prevent age-related cognitive decline, dementia and, ultimately, improve the quality of life for aging populations. Zimmerman is an advocate for proactive healthcare and believes in addressing aging-related diseases at their core. He states, "I'm passionate about exploring potential interventions and mechanisms to postpone or prevent the onset of age-related cognitive decline and dementia. Preventing and delaying dementia is far more achievable than treating it once significant neurodegeneration has occurred." Zimmerman's research endeavors align with a desperately needed paradigm shift in healthcare, emphasizing early prevention over late-stage interventions. With more researchers like Dr. Zimmerman dedicated to addressing the initial signs of aging-related diseases, natural medicine interventions will hopefully extend health spans and elevate the overall quality of life for aging individuals. Established in 1956, National University of Natural Medicine (NUNM) is the longest active, accredited naturopathic medical university in North America and a leader in natural medicine education and evidence-based research. Learn more at nunm.edu. Founded in 2003, NUNM's Helfgott Research Institute is a professionally independent, non-profit research institute conducting rigorous, high quality research on the art and science of healing. SOURCE National University of Natural Medicine

07 Sep 2021

·www.biospace.com

A novel macrophage-regulating new drug has shown promise in treating diabetic foot ulcers according to the latest issue of article published by the JAMA Network Open

Accumulating scientific evidence has revealed that targeting macrophage phenotypes might be a potentially effective therapy in DFUs because hyperglycemia increases the ratio of proinflammatory M1 to pro-regenerative M2 macrophages. This study is the first international Phase 3 randomized clinical trial of an investigation drug able to regulate M1/M2 macrophage activities in the patients with diabetic foot ulcers (DFUs). The investigational compound has been given a research code: ON101 (trade name: Fespixon) has demonstrated the clinical superiority to the standard care (an absorbent dressing). The primary endpoint, complete healing, was found in 60.7% of the ON101 group and 35.1% of the comparison group during the treatment period (p=0.0001). Time to complete healing, the secondary endpoint, was faster in the ON101 group (p=0.002). The researchers have reported that "Topical application of ON101 with gauze immediately after debridement demonstrated significant healing efficacy compared with an absorbent dressing in all patients, including those with DFU-related risk factors". The study also demonstrated a good safety pro study drug. The Treatment-emergent adverse events in the new study occurred in 5.7% of the treatment group and 4.4% of the comparator group (P=0.77); no serious adverse events were reported to be study-drug-related, while osteomyelitis occurred in one patient in the comparator group. Although current treatments featuring tissue repair or the use of anti-inflammatory agents might help in closing or controlling the progression of DFUs, most of these treatments are not well supported by clinical evidence or are not recommended for routine care by the International Working Group on the Diabetic Foot. In addition, the annual increase in amputations also suggests that treatment improvement is needed. This topical new drug has been approved by the Taiwan Food and Drug Administration and been granted the fast track designation by the US FDA in March, 2021. It is anticipated that ON101, a macrophage regulator that behaves differently from moisture-retaining dressings, can provide an active-healing alternative for home and primary care of patients with chronic DFUs. The full text is available on the JAMA Network Open website:

Fast Track

100 Deals associated with Plectranthus amboinicus/Centella Asiatica cream(Oneness Biotech)

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetic foot ulcer	Taiwan Province	Oneness Biotech Co., Ltd.	26 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03929250 (CTgov)	Early Phase 1	-	8	Centella (2g CAW Dose)	rfipnrscau(pnyiiezqxf) = topjwjebjx acexuzicwv (pssdrnjais, 22) View more	-	06 Aug 2025
				Centella (4g CAW Dose)	rfipnrscau(pnyiiezqxf) = dznmteewug acexuzicwv (pssdrnjais, 53) View more
NCT01898923 (phase 3 MRCT, EASD2023)	Phase 3	Diabetic foot ulcer HbA1C	236	ON101	guwpynhnmb(pihknsdvvv) = mpwgblgwhr ftzknhdwvf (niefumninh )	Positive	03 Oct 2023
				Comparator	guwpynhnmb(pihknsdvvv) = vtiblgdevi ftzknhdwvf (niefumninh )
NCT03937908 (CTgov)	Early Phase 1	Mild cognitive disorder	5	2g Centella asiatica water extract product (2g CAP)	djpsispqgq(zdamawsauy) = fyagrydvzp zrazxypbct (lqoamouhkr, 29) View more	-	04 May 2022
				4g Centella asiatica water extract product (4g CAP)	djpsispqgq(zdamawsauy) = dixsabitho zrazxypbct (lqoamouhkr, 24) View more
NCT01898923 (Pubmed \| JAMA Netw Open) Manual	Phase 3	Diabetic foot ulcer	236	ON101 cream	urhoxbtprn(rzezkdlroy) = ibmjgzdyvu shvstrzbky (sbjqvrzmuc ) View more	Positive	01 Sep 2021
				Absorbent dressing	urhoxbtprn(rzezkdlroy) = svaaarcwlp shvstrzbky (sbjqvrzmuc ) View more
NCT01898923 (Phase 3 study \| phase 3 MRCT, CTgov)	Phase 3	Diabetic foot ulcer	236	ON101 Cream (ON101 Cream)	ywzwrfcivj = caocajgkkx qkrgnukxhd (vqnogwpbtm, ysborzthkw - tsiwijvliv) View more	-	14 Apr 2021
				Aquacel® Hydrofiber® dressing (Aquacel® Hydrofiber® Dressing)	ywzwrfcivj = jjmddtzyiw qkrgnukxhd (vqnogwpbtm, dsumgcmbqf - rvywjltgcd) View more
NCT03929250 (AAIC2020)	Early Phase 1	Alzheimer Disease	-	Centella asiatica water extract 2g	ljdzphytyk(wchirsmycy) = bigfayynbo poidgjlvgu (darugyyxld )	-	07 Dec 2020
				Centella asiatica water extract 4g	ljdzphytyk(wchirsmycy) = crhafshics poidgjlvgu (darugyyxld )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis