The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to answer:
1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify?
2. What percentage of patients achieve a clinical response?
Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

Start Date01 Nov 2024

Sponsor / Collaborator

Montefiore Medical Center

NCT06411002 / RecruitingPhase 2

A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).
Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

Start Date08 Apr 2024

Sponsor / Collaborator

Revance Therapeutics, Inc.

NCT06225492 / RecruitingPhase 4IIT

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

Start Date01 Jan 2024

Sponsor / Collaborator

Main Line Center for Laser Surgery

100 Clinical Results associated with Daxibotulinumtoixn A-LANM

100 Translational Medicine associated with Daxibotulinumtoixn A-LANM

100 Patents (Medical) associated with Daxibotulinumtoixn A-LANM

Literatures (Medical) associated with Daxibotulinumtoixn A-LANM

01 Dec 2024·Journal of Plastic Reconstructive and Aesthetic Surgery

DaxibotulinumtoxinA for injection to treat moderate or severe glabellar lines: A randomized, multicenter, Phase III, double-blind, placebo-controlled trial in China

Article

Author: Ge, Lei ; Wang, Hui ; Sun, Jiaming ; Li, Li ; Guo, Qing ; Li, Qingfeng ; Wang, Xingli ; Wang, Baoxi ; Liu, Quanzhong ; Fan, Xiaojing ; Su, Juan ; Zhao, Hongyi ; Xie, Yun

BACKGROUND:

DaxibotulinumtoxinA for injection (DAXI), a novel botulinum toxin type A formulation, is FDA-approved for glabellar lines treatment. Its clinical efficacy has been demonstrated in two Phase III trials (SAKURA 1 and SAKURA 2).

OBJECTIVE:

To evaluate DAXI efficacy and safety in Chinese adults with moderate/severe glabellar lines.

METHODS:

In this Phase III, randomized (2:1), double-blind trial, Chinese adults with moderate/severe glabellar lines received 40 U DAXI or placebo into the corrugator muscles bilaterally and the procerus. Glabellar line severity was evaluated by investigators (Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] scale) and participants (Patient Frown Wrinkle Severity [PFWS] scale) for ≥24 to 36 weeks. The primary endpoint was the proportion of 2-point composite responders achieving ≥2-point reduction in IGA-FWS and PFWS scores at week 4 post-treatment.

RESULTS:

Overall, 307 participants received treatment (DAXI, 205; placebo, 102). A significantly greater proportion of participants in the DAXI arm vs the placebo arm achieved a 2-point composite response at week 4: 125 (61.0%) vs 1 (1.0%); difference, 60.0% [95% CI 49.40-66.46]; 2-sided p < 0.0001). At week 4, 94.1% of the DAXI-treated participants achieved an IGA-FWS score 0/1 (none/mild) and 86.3% achieved PFWS 0/1; median time to loss of none/mild on IGA-FWS and PFWS was 23.9 weeks. The benefits of DAXI over placebo through week 24 occurred regardless of the baseline IGA-FWS score, prior botulinum toxin type A (BoNTA) exposure, sex or age. DAXI was well tolerated with no new safety signals.

CONCLUSION:

DAXI provided durable efficacy and acceptable safety for treating moderate/severe glabellar lines in Chinese participants.

01 Sep 2024·DERMATOLOGIC SURGERY

Clinical Benefits of DaxibotulinumtoxinA for Injection: Beyond Glabellar Line Effacement?

Review

Author: Shamban, Ava ; Green, Jeremy B. ; Gross, Todd M. ; Mariwalla, Kavita ; Brown, Jessica ; Gallagher, Conor J.

BACKGROUND:

Botulinum toxin type A (BoNTA) is standard of care for glabellar lines ameliorization. DaxibotulinumtoxinA for Injection (DAXI) is a new BoNTA with a unique formulation representing the latest advancement in BoNTA technology. There is an unmet need for patients to understand the full potential of BoNTA treatment and new technologies.

OBJECTIVE:

To update clinical data supporting the use of DAXI for glabellar lines within the context of clinical experience.

MATERIALS AND METHODS:

A narrative review of the literature and summary of clinical experience with DAXI.

RESULTS:

The DAXI clinical trial program reflects clinical experience post-FDA approval, with DAXI demonstrating rapid onset, high patient response rates, and extended treatment duration versus conventional BoNTAs. Clinical observations suggest that DAXI has limited diffusion from the injection site, enabling more localized control of muscle activity and greater improvements in wrinkle severity. DAXI enables practitioners to exert greater finesse in their injections and in predicting changes to eyebrow shape and position and achieve improvement in skin quality.

CONCLUSION:

Advances in BoNTA technology can provide patients with greater options for treatment outcomes. The potential for enhanced localized effects with DAXI may contribute to more precise and targeted effects on muscle activity and additional aesthetic benefits to patients.

27 Feb 2024·Neurology

Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia

Article

Author: Cooper, Christine ; Yegiaian, Sharon ; Truong, Daniel ; Mcallister, Peter ; Kumar, Rajeev ; Hedera, Peter ; Sycha, Thomas ; Heitzman, Daragh ; Harrower, Timothy ; Bouhour, Francoise ; Paus, Sebastian ; Isaacson, Stuart ; Szabela, Dariusz ; Moore, Peter ; Dashtipour, Khashayar ; Haslinger, Bernhard ; Ehler, Edvard ; Hermanowicz, Neal ; Koziorowski, Dariusz ; Manzanares, Lydia Lopez ; Kollewe, Katja ; Feigenbaum, Danielle ; Barbano, Richard ; Mora, Javier Pagonabarraga ; Singer, Carlos ; Gitt, Jeffrey ; Bettle, Norman ; Ondo, William ; Tse, Winona ; Lohmann, Ebba ; Gross, Todd M. ; Evidente, Virgilio ; Kobylecki, Christopher ; LeDoux, Mark ; Kupsch, Andreas ; Goudreau, John ; Tate, Jessica ; Frei, Karen ; Ellenbogen, Aaron ; Bösch, Sylvia ; Kompoliti, Aikaterini ; Pillai, Rekha ; Trejo, Jose Maria ; Vasquez, Alberto ; Deik, Andres ; Slawek, Jaroslaw ; Comella, Cynthia L. ; Massey, Janice ; Rubio, Roman G. ; Vitarella, Domenico ; Moro, Elena ; Woznicova, Ivana ; Criswell, Susan ; Jankovic, Joseph ; Boyd, James ; Kreisler, Alexandre ; Hernandez-Vara, Jorge ; Patel, Atul T. ; Thakur, Nicklesh ; Tutaj, Andrzej ; Schwartz, Harvey ; LeWitt, Peter ; Hauser, Robert A. ; Castelnovo, Giovanni ; Chand, Pratap ; Banach, Marta D. ; Habibi, Behzad ; Jech, Robert ; Jinnah, Hyder ; Isaacs, David ; Peckham, Elizabeth ; Rudzinska, Monika ; Malaty, Irene ; Vysata, Oldrich ; Albrecht, Philipp ; Torres, Diego ; Fox, Susan

BACKGROUND AND OBJECTIVES:

ASPEN-1 was a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, duration of response, and safety of 2 doses of DaxibotulinumtoxinA for Injection (DAXI), a novel botulinum toxin type A formulation in participants with cervical dystonia (CD).

METHODS:

Adults (aged 18-80 years) with moderate-to-severe CD (Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] total score ≥20) were enrolled at 60 sites across 9 countries in Europe and North America. Participants were randomized (3:3:1) to single-dose intramuscular DAXI 125U, 250U, or placebo and followed for up to 36 weeks after injection. The primary end point was change from baseline in TWSTRS total score averaged across weeks 4 and 6. Key secondary end points included duration of effect, Clinical and Patient Global Impression of Change (CGIC, PGIC), TWSTRS subscale scores, and safety. Multiplicity-adjusted intent-to-treat hypothesis tests with multiple imputation were performed using ANCOVA and Cochran-Mantel-Haenszel analyses.

RESULTS:

Of 444 individuals screened, 301 were randomized to DAXI 125U (n = 125) or 250U (n = 130) or placebo (n = 46). DAXI 125U and 250U significantly improved the mean TWSTRS total score vs placebo (least squares mean [standard error] difference vs placebo: DAXI 125U, -8.5 [1.93], p < 0.0001; DAXI 250U, -6.6 [1.92], p = 0.0006). The median duration of effect (time from treatment until loss of ≥80% of the peak improvement in average TWSTRS total score achieved at weeks 4 and 6) was 24.0 (95% confidence interval 20.3-29.1) weeks with DAXI 125U and 20.3 (16.7-24.0) weeks with DAXI 250U. Significant improvements were also observed with DAXI in CGIC and PGIC responder rates and TWSTRS subscales. Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.6% of participants with DAXI 125U, 23.8% with DAXI 250U, and 17.4% with placebo, with injection site pain being the most common overall. The most frequently reported treatment-related TEAEs of interest in DAXI 125U, DAXI 250U, and placebo, respectively, were muscular weakness (4.8%, 2.3%, 0%), musculoskeletal pain (2.4%, 3.1%, 0%), and dysphagia (1.6%, 3.8%, 0%).

DISCUSSION:

This study demonstrated that DAXI, at doses of 125U and 250U, is an effective, safe, long-acting, and well-tolerated treatment for CD.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.gov identifier (NCT03608397, submitted July 11, 2018) and EU Clinical Trials Register (ClinicalTrialsRegister.eu EudraCT identifier 2018-000446-19, submitted September 13, 2018). First participant enrolled on June 11, 2018. Trial registration was performed in accordance with the Food and Drug Administration Amendments Act (FDAAA 801), which stipulates that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human participant (42 CFR 11.24).

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that in adults with moderate-to-severe idiopathic cervical dystonia, DAXI reduces dystonia more effectively than placebo.

News (Medical) associated with Daxibotulinumtoixn A-LANM

30 Oct 2024

·www.prnewswire.com

Fosun Pharma Announces 2024Q3 Financial Results

Revenue Exceed RMB30.9 Billion with R&D Expenditure RMB3.9 Billion Continuing to Consolidate its Dominant Position In The fields of Breast Cancer and Lung Cancer SHANGHAI, Oct. 29, 2024 /PRNewswire/ -- On October 29, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first three quarters of 2024. From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY. In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis. Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma's R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D. Fosun Pharma's innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products. In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma's cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite's marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite's pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma. In the third quarter of 2024, Fosun Pharma's multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients. The multicenter real-world study of Fosun Pharma's self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma's self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP's opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval. Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines. Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company's future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan. Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China's 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices. *** About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit the official website: SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyDrug ApprovalPhase 2Phase 3

28 May 2024

·www.biospace.com

Revance to Participate in Upcoming June 2024 Investor Conferences

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (NASDAQ: RVNC) today announced that the company will be participating in the following investor conferences. William Blair 44th Annual Growth Stock Conference Chief Financial Officer Tobin Schilke is scheduled to present on Tuesday, June 4, 2024, at 11:20 am CT, in Chicago, Illinois. Goldman Sachs 45th Annual Global Healthcare Conference President and Chief Executive Officer Mark J. Foley is scheduled to present on Tuesday, June 11, 2024, at 8:00 am ET, in Miami, Florida. Interested parties can access the live audio webcasts for the conferences from the Investor Relations section of the company's website at . The webcast replays will be available after the conclusion of the live presentations for approximately 90 days. About Revance Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY in China. Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn. “Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA. View source version on businesswire.com: Contacts Investors Laurence Watts, 619-916-7620 laurence@newstreetir.com Media Revance@evolvemkd.com Source: Revance Therapeutics, Inc. View this news release online at:

02 May 2024

·www.biospace.com

Revance to Release First Quarter 2024 Financial Results on Thursday, May 9, 2024

Conference Call Scheduled for Thursday, May 9, 2024 at 4:30 p.m. ET. NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced that the company will release first quarter 2024 financial results on Thursday, May 9, 2024, after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a corporate update. Individuals interested in listening to the conference call may do so by dialing (833) 470-1428 for U.S callers and (929) 526-1599 for other locations and reference conference ID 663066, or from the webcast link in the investor relations section of the company's website at . A webcast replay will be available beginning May 9, 2024, at 4.30 p.m. PT / 7.30 p.m. ET to August 9, 2024, at 4.30 p.m. PT / 7.30 p.m. ET. To access the replay, please register via the webcast link on the events page. The webcast will be available in the investor relations section on the company's website for 90 days following the completion of the call. About Revance Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China. Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn. “Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA.

Financial Statement

100 Deals associated with Daxibotulinumtoixn A-LANM

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
cervical dystonia	US	Revance Therapeutics, Inc.	11 Aug 2023
Glabellar frown lines	US	Revance Therapeutics, Inc.	07 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Torticollis	NDA/BLA	US	Revance Therapeutics, Inc.	20 Oct 2022
Isolated cervical dystonia	Phase 3	US	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	AT	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	CA	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	CZ	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	FR	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	DE	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	PL	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	ES	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	GB	Revance Therapeutics, Inc.	05 Sep 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02973269 (CTgov)	Phase 2	Fasciitis, Plantar	7	daxibotulinumtoxin type A (DAXI 240 U)	tnizubhogt(njbxdnzdhu) = aeasrnmknl ekiiefdtgh (ktprhmzlud, kdgoikqwak - lowgtschll) View more	-	03 Apr 2024
				Placebo (Placebo)	tnizubhogt(njbxdnzdhu) = pzqxkgkrxb ekiiefdtgh (ktprhmzlud, hjpqmpelqp - wjzbpmwykj) View more
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed) Manual	Phase 3	cervical dystonia	301	DAXI125U	hvisdcklwp(mobahrkavc) = ejvmgcxauf yvzntgsvdi (ankhpsdiil, 1.30) View more	Positive	31 Jan 2024
				DAXI250U	hvisdcklwp(mobahrkavc) = syhppahbqc yvzntgsvdi (ankhpsdiil, 1.25) View more
NCT03825315 (CTgov)	Phase 2	Fasciitis, Plantar	155	DAXI 80 U (DAXI 80 U)	agpnpfzqbf(evtcfoexhl) = azdyjatreb egdncwxrmf (rncrfrebba, xenfrbkecz - gadbdzjkqh) View more	-	21 Sep 2023
				DAXI 120 U (DAXI 120 U)	agpnpfzqbf(evtcfoexhl) = vrjhnuvwcc egdncwxrmf (rncrfrebba, igizmmtzkk - bdoyorqsaq) View more
NCT03608397 (FDA) Manual	Phase 3	cervical dystonia	301	Placebo	cdkhchchqm(onhbfeffxe) = hfizspwynm olvqxfajik (wnwoznduwx )	Positive	11 Aug 2023
				DAXI 125 U	cdkhchchqm(onhbfeffxe) = gciyzaxeed olvqxfajik (wnwoznduwx )
GL-2 (FDA) Manual	Not Applicable	Glabellar frown lines	609	DAXXIFY (STUDY GL-1)	tlztlgfqep(kylekfdnhw) = atvxlagdlt xwdezyjnqy (etzmyxmbie ) View more	Positive	11 Aug 2023
				Placebo (STUDY GL-1)	tlztlgfqep(kylekfdnhw) = iqjsnwtbrf xwdezyjnqy (etzmyxmbie ) View more
NCT03911102 (CTgov)	Phase 2	Lateral Canthal Lines	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	bwfcckwbcp(cwraqaojmo) = idybsbzegt vfniafhiow (prbqqzxnsy, lzygzidndk - vlzqrgdwfv) View more	-	27 Jun 2023
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	bwfcckwbcp(cwraqaojmo) = ijbaettmyf vfniafhiow (prbqqzxnsy, rpqieppbim - xoxosysgpr) View more
NCT04259086 (CTgov)	Phase 2	Glabellar frown lines	48	DaxibotulinumtoxinA for injection	yjagpgxphp(qbjndbttxy) = rsxesfhpsj aoduqxxqfw (zjuzgqwszh, xygcpvnrlh - ekfrqicrjr) View more	-	27 Jun 2023
ASPEN-1 and ASPEN-OLS (AAN2023)	Phase 3	cervical dystonia	-	Placebo	jjmipumrwj(nurkbsxnof) = hzozlsyvry nvovnouptw (fyjlqhtbrv )	Positive	25 Apr 2023
				DAXI 125U	jjmipumrwj(nurkbsxnof) = ygvhrwncmm nvovnouptw (fyjlqhtbrv )
ASPEN-OLS Trial (P11-11.003) (AAN2023)	Phase 3	Isolated cervical dystonia	357	DaxibotulinumtoxinA 125U	zvlmqxoqlb(pesjpmviul) = Commonly reported treatment-related treatment-emergent adverse events (TEAEs) (≥5% of subjects overall) were dysphagia, muscular weakness, and injection site pain. TEAE rates remained stable or decreased after repeat dosing. Treatment-related dysphagia was reported in 3.9%, 4.3%, 4.7%, and 3.1% of subjects in Cycles 1-4, respectively (4.2% of 985 DAXI treatments). There were no serious treatment-related TEAEs. cwhihnwlyx (amlcrzpzdg ) View more	Positive	25 Apr 2023
				DaxibotulinumtoxinA 250U
NCT04259086 (Pubmed)	Phase 2	Facial wrinkles	48	DaxibotulinumtoxinA-lanm 40U (glabellar)	hrdmlzwpqn(uyuhcgqdor) = No patients experienced eyebrow or eyelid ptosis nvlvzxemyh (wsjcpdmyxu ) View more	-	01 Jan 2023
				DaxibotulinumtoxinA-lanm 32U (forehead)

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