Efficacy and Safety of Liposomal Bupivacaine Combined With Compound Betamethasone for Local Analgesia in Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial

Start Date23 Jul 2026

Sponsor / Collaborator

West China Hospital

CTRI/2026/06/112933

/ Not yet recruitingPhase 4IIT

A COMPARATIVE STUDY TO EVALUATE THE EFFECTIVENESS OFBETAMETHASONE GEL LIGNOCAINE JELLY AND NATURAL JELLY APPLIEDTO ENDOTRACHEAL TUBE CUFF ON POSTOPERATIVE SORE THROAT APROSPECTIVE DOUBLE BLIND RANDOMISED CONTROL STUDY - NIL

Start Date30 Jun 2026

Sponsor / Collaborator-

100 Clinical Results associated with Betamethasone

100 Translational Medicine associated with Betamethasone

100 Patents (Medical) associated with Betamethasone

5,652

Literatures (Medical) associated with Betamethasone

01 Oct 2026·Journal of Pediatric Urology

Real-world outcomes of topical corticosteroids for pediatric phimosis: The impact of lichen sclerosus and second-line clobetasol

Article

Author: Tobia Gonzalez, Sebastian ; Maiolo, Anabella ; Tobia Gonzalez, Ignacio ; Krikorian, Jimena

OBJECTIVE:

Topical corticosteroids are widely used as first-line therapy for pediatric phimosis, with high success rates reported in controlled studies. However, outcomes in routine clinical practice may be more variable. We evaluated real-world outcomes of topical corticosteroid therapy for pediatric phimosis and explored factors associated with treatment response, including treatment strategy, age, and clinical findings suggestive of Lichen Sclerosus (LS).

MATERIALS AND METHODS:

A prospective observational cohort study was conducted including pediatric patients treated for pathologic phimosis between 2018 and 2023. Patients received a 30-day course of topical corticosteroid therapy with betamethasone as first-line treatment (G1), clobetasol as first-line treatment (G2), or clobetasol as second-line treatment after failure of betamethasone (G3). Treatment response was defined as complete foreskin retractability with adequate hygiene, symptom resolution, and no requirement for surgery after a minimum follow-up of 6 months. Associations between treatment response and treatment strategy, age, and clinical findings compatible with LS were analyzed.

RESULTS:

A total of 214 patients were included (mean age 6.7 years; range 1-17 years). Of these, 156 received betamethasone as first-line therapy (G1), 38 received clobetasol as first-line therapy (G2), and 20 received clobetasol as second-line therapy (G3). Response rates were 33.3% in G1, 36.8% in G2, and 60.0% in G3. Clinical findings suggestive of LS were present in 18 patients at presentation; none demonstrated definitive treatment response, 16 ultimately required surgery, and 2 remained under follow-up at the time of analysis. Age was not significantly associated with treatment response. Histopathological findings, available only in surgically treated patients, frequently demonstrated lichenoid changes or definite BXO/LS.

CONCLUSION:

In this real-world cohort, response rates to topical corticosteroid therapy were lower than those reported in controlled studies. Clinical findings suggestive of LS were strongly associated with poorer outcomes. In selected patients who failed initial betamethasone therapy, escalation to clobetasol may provide additional benefit before surgery, although this finding should be interpreted cautiously given the observational study design.

01 Sep 2026·EXPERIMENTAL EYE RESEARCH

Inhibitory effect of the water-soluble retinoid X receptor partial agonist CAt-PMN on allergic conjunctivitis-like responses in mice

Article

Author: Sugimoto, Yukio ; Pflugfelder, Stephen C ; Hino, Yuta ; Kakuta, Hiroki ; Ogura, Atsushi ; Alam, Jehan ; Takamura, Yuta ; Takimoto, Yuka

Allergic conjunctivitis (AC) is an immune-mediated inflammatory disease of the conjunctiva characterized by ocular itching, hyperaemia, and edema, and inflammatory cell infiltration. Though topical glucocorticoids (steroidal anti-inflammatory drugs) are effective for a broad range of signs and symptoms of ocular inflammation, their use is limited by potential adverse effects, including elevated intraocular pressure (IOP). Therefore, steroidal sparing-therapeutic approachs for AC are needed. Here we report a therapeutic effect of CAt-PMN, the highly water-soluble retinoid X receptor (RXR) partial agonist, in a mouse model of AC. ICR mice were sensitized by intraperitoneal injection of ovalbumin (OVA) on days 0 and 5, followed by topical OVA challenge once a daily from day 14 to day 28. Betamethasone (0.1% w/v) or CAt-PMN (0.0035 or 0.035% w/v) was instilled into both eyes before each topical OVA challende. Repeated topical administration of CAt-PMN suppressed eye scratching behavior, allergic-like clinical symptoms, and eosinophils infiltration of into tears in a dose dependent manner. In a separate repeated-dose IOP study using C57BL/6 mice, topical dexamethasone at 1 μM induced a marked IOP elevation, whereas topical CAt-PMN at 1 μM did not under the conditions tested. These findings suggest that CAt-PMN may be a promising steroid-sparing therapeutic candidate for AC, although further studies using the same mouse strain and detailed ocular pharmacokinetic and safety evaluations are warranted.

01 Aug 2026·Epilepsy Currents

Blockade of Corticotropin-Releasing Hormone Receptor 1 Receptors in the Arcuate Nucleus May Effectively Treat Infantile Epileptic Spasms Syndrome

Article

Author: Goodman, Jeffrey H.

Targeting Corticotropin-Releasing Hormone Receptor 1 Signaling in Experimental Infantile Epileptic Spasms Syndrome: Evidence for Route-Dependent Efficacy.Chachua T, Yum MS, Chern CR, Vieira K, Velíšková J, Velíšek L. Targeting CRHR1 Signaling in Experimental Infantile Epileptic Spasms Syndrome: Evidence for Route-Dependent Efficacy. Children (Basel). 2026 Jan 14;13(1):125. doi: 10.3390/children13010125. PMID: 41597133; PMCID: PMC12840083.Background/Objectives: Infantile epileptic spasms syndrome (IESS) is a severe epilepsy of infancy. Corticotropin (ACTH) and vigabatrin are the only FDA-approved therapies. The efficacy of ACTH together with the strong convulsant effects of corticotropin-releasing hormone (CRH) suggests that excess CRH, secondary to impaired ACTH feedback, may contribute to spasms. We therefore hypothesized that CRH receptor 1 (CRHR1) antagonists would suppress spasms in a route- and drug-dependent manner. Methods: Using our validated rat model of IESS, in which prenatal priming with betamethasone was followed by postnatal triggering of spasms with N-methyl-D-aspartic acid (NMDA), we tested two CRHR1 antagonists, CP376395 and SN003, delivered intracranially (via intracerebroventricular or intraparenchymal infusion) or systemically. Results: Intracerebroventricular infusion of both antagonists suppressed spasms, with CP376395 providing more consistent effects. Intraparenchymal administration into the hypothalamic arcuate nucleus also reduced spasms, whereas misses into the mammillary bodies were ineffective, highlighting site specificity. Systemic administration yielded divergent results: SN003 robustly suppressed spasms, whereas CP376395 unexpectedly exacerbated them. No sex differences were observed. Conclusions: These findings demonstrate that CRHR1 blockade modifies experimental spasms in a route- and drug-specific manner and implicates discrete hypothalamic circuits, particularly those including the arcuate nucleus, in spasm generation. The divergent systemic responses between CP376395 and SN003 likely reflect differences in CRHR1 engagement (competitive and non-competitive antagonism, respectively) as well as differences in binding properties that may include differential network interactions beyond local CRH signaling or duration of receptor occupancy. In conclusion, SN003 may be a better option than CP376395 for further development as a CRHR1-targeted therapy pending additional pharmacokinetic/pharmacodynamic studies. Further work should explore dosing paradigms of CP376395 to determine if a therapeutic range for CP376395 exists.

108

News (Medical) associated with Betamethasone

19 Jul 2026

·www.einpresswire.com

Patients Already on the Knee Replacement Waiting List Find Platelet-Rich Plasma Outperformed Cortisone and NSAIDS

Patients with "bone-on-bone" arthritis, PRP produced sustained pain and function and measurable shifts in cartilage breakdown. A knee replacement is a wonderful operation, but it is major, irreversible surgery with a finite lifespan, and the younger you have it, the more likely you are to outlive it.” — Gurpreet Singh Padda, MD ST. LOUIS, MO, UNITED STATES, July 19, 2026 / EINPresswire.com / -- Randomized Trial in Patients Already on the Knee Replacement Waiting List Finds Platelet-Rich Plasma Outperformed Cortisone and Anti-Inflammatories — Including in Blood Chemistry In 90 patients with "bone-on-bone" arthritis, PRP produced sustained pain and function gains at six months, lower opioid use, and measurable shifts in cartilage breakdown and inflammatory biomarkers. St. Louis physician Gurpreet Padda, MD: "We are not regrowing your cartilage — and the honest version is still the better story." A randomized controlled trial accepted for publication in the Journal of Orthopedic Surgery and Research has reported that two injections of autologous platelet-rich plasma (PRP) outperformed both corticosteroid injection and oral anti-inflammatory medication in patients with late-stage knee osteoarthritis — and did so not only on pain and function scores, but on serum markers of inflammation and cartilage breakdown. The trial is notable for who it enrolled. All 90 participants had Kellgren-Lawrence grade 3 or 4 disease — the radiographic stages routinely described to patients as "bone-on-bone" — and all were already on the waiting list for total knee replacement. This is the population most biologic injection trials exclude. Gurpreet Padda, MD, MBA, who directs the regenerative and metabolic medicine practice, Regen.MD in St. Louis has built patient and physician education around the findings. "There's a sentence said in exam rooms every day: you're bone on bone, there's nothing left to do, we just have to replace it," said Dr. Padda. "That sentence is a lie — not a malicious one. Most of the doctors who say it genuinely believe it. But it's built on a way of thinking about the body that is decades out of date, and the data directly contradict that way of thinking. These were not easy early cases. These were the patients everyone had already given up on, sitting on a surgical waiting list." What the Trial Found Lacko and colleagues at P. J. Šafárik University and L. Pasteur University Hospital in Košice, Slovakia, enrolled 90 patients aged 40 to 80 between September 2024 and June 2025, randomizing them to three arms: two intra-articular injections of non-activated autologous PRP one week apart; a single intra-articular betamethasone (corticosteroid) injection; or oral aceclofenac, an NSAID. Patients were followed for six months, with clinical scores and a 13-marker serum biomarker panel measured at baseline, three months, and six months. Eighty-two patients completed follow-up. Pain. Visual analog scale scores fell significantly only in the PRP group, from 6.2 at baseline to 3.3 at three months, holding at 3.7 at six months. The corticosteroid group moved from 6.3 to 5.8, and the NSAID group from 6.3 to 5.8 — neither a statistically significant change from baseline. Between-group differences favored PRP at three months (p<0.001 versus both controls) and six months (p=0.004 versus corticosteroid; p=0.002 versus NSAID). Function and stiffness. Total WOMAC scores improved only in the PRP arm, from 49.0 to 28.1 at three months and 32.5 at six months, with significant gains across pain, stiffness, and function subscales. Corticosteroid scores were essentially unchanged at 45.6, and the NSAID group deteriorated, from 48.8 at baseline to 57.9 at six months. Opioid use. Rescue opioid consumption, standardized to morphine milligram equivalents, was lowest in the PRP group — significantly lower than corticosteroid at both three months (p=0.002) and six months (p=0.006), and lower than NSAID at three months (p=0.025). Dropouts. No patient in the PRP arm withdrew. Two corticosteroid patients and four NSAID patients discontinued after three months because their pain was never adequately controlled, and proceeded to earlier total knee replacement. Two additional NSAID patients were withdrawn after worsening ischemic heart disease. Biomarkers. Compared with the corticosteroid group at three months, PRP patients showed significant reductions in the cartilage-turnover and inflammatory markers COMP (p=0.015), MMP-3 (p=0.024), IL-6 (p=0.035), IL-18 (p=0.037), and TNF-α (p=0.017), alongside increases in the anti-inflammatory and anabolic markers sTREM2 (p=0.019), sRAGE (p=0.017), and TGF-β1 (p=0.048). CGRP — a neuropeptide associated with peripheral pain sensitization — was significantly lower in the PRP group than in both controls (p=0.032 and p=0.024). Reductions in COMP, IL-6, and IL-18 were still present at six months. Safety. Three PRP patients experienced transient knee pain and swelling that resolved within one day. No other adverse events were recorded in the PRP arm. The authors' stated conclusion is that PRP is supported as "a safe bridge therapy before arthroplasty." The Line Regen.MD Insists On Dr. Padda's educational materials make one limitation non-negotiable. "We are not regrowing your cartilage. The gap on your X-ray is not going to close," Dr. Padda said. "PRP is not a magic serum that reverses structural damage, and anyone promising you a brand-new joint from an injection is selling a fantasy that will cost you money and hope. The RESTORE trial in JAMA showed that in milder osteoarthritis, PRP did not regrow cartilage or beat placebo in terms of structure. That finding is real, and I respect it. How do I hold both truths? Pain and structure are decoupled. We are not changing the architecture of the knee. We are changing its biology — and in advanced disease, that biological change is what produced measured relief. I would rather tell you a smaller true thing than a bigger false one." What the Trial Does Not Establish Regen.MD's materials present the study's limitations alongside its results. The investigators state that participants were not blinded to their assigned intervention; that the three arms differed in route of administration, dosing frequency, and overall treatment intensity, which limits direct comparability; and that the PRP product was not quantitatively characterized in this trial. It was a single-center study. The NSAID arm had a substantial dropout rate due to adverse effects and inadequate pain control. Biomarker analyses were exploratory, and no correction for multiple comparisons was applied. No structural imaging endpoint was assessed, and the trial makes no claim of cartilage regrowth. It also did not measure how many patients ultimately avoided or deferred surgery — the only surgical events recorded were the six control-arm patients who proceeded to earlier replacement. Converging Evidence on Treating the Bone Itself A second randomized controlled trial, published in the Journal of Clinical Medicine in November 2025, addressed a related question in the same severity range. Sánchez Santiuste and colleagues randomized 86 patients with Kellgren-Lawrence grade III–IV knee osteoarthritis in a double-blind multicenter design. All patients received intra-articular Plasma Rich in Growth Factors; the arms differed by whether they also received an intraosseous infiltration into the subchondral bone, or an intraosseous saline placebo. The intraosseous group improved significantly more across nearly all domains at 3, 6, and 12 months, with 66.7% reaching minimum clinically important improvement in pain versus 46.3% (p=0.0038). No serious adverse events occurred. That trial likewise assessed no structural imaging, and PRGF is a specific leukocyte-poor preparation whose results do not automatically transfer to other platelet systems. "The objection to biologics in advanced arthritis was always anatomical, and it sounded reasonable: there's no cartilage left, so what are you signaling to," Dr. Padda said. "But in an end-stage knee, the subchondral bone is not inert scaffolding. It's edematous, hypervascular, densely innervated, and remodeling badly, and it generates a substantial share of the pain. Treating only the joint space in a grade IV knee means treating the one compartment where the disease has already finished its work." Regen.MD performs both intra-articular and intraosseous PRP. Service Availability at Regen.MD The practice's orthobiologics program provides image-guided biologic procedures, including intra-articular and tendon PRP in leukocyte-poor and leukocyte-rich preparations, intraosseous/subchondral PRP, bone marrow aspirate concentrate (BMAC), adipose-derived Lipogems grafts, and intradiscal orthobiologics. Every needle is placed under ultrasound or fluoroscopic guidance rather than by anatomical landmark, and diagnostic blocks are used to confirm the pain generator before a biologic is deployed. The practice's published indication for subchondral treatment is the joint that still hurts after a technically correct intra-articular injection. As its service materials put it, MRI bone-marrow lesions — edema in the subchondral bone beneath a worn surface — track closely with pain and progression, "and a joint-space injection never reaches them." Under fluoroscopic guidance, platelet concentrate is delivered through the cortex into the subchondral bone itself, typically paired with an intra-articular dose — the same combination tested in the Sánchez Santiuste trial. Regen.MD's published protocol emphasizes matching the preparation to the tissue — leukocyte-rich for tendon, leukocyte-poor for intra-articular and subchondral use — and treating the injectate as a biological drug prepared to a measured therapeutic threshold. The practice's stated position is that "PRP is not one product, and most failures start here," and that "a perfect biologic in the wrong tissue plane is an expensive placebo." Procedures are paired with the practice's work in metabolic inflammation and its laboratory-guided peptide therapy program, on the rationale that a repair signal delivered into an inflamed, insulin-resistant environment is unlikely to hold. The practice treats chronic back pain, joint dysfunction, metabolic inflammation, and neuropathic pain, and describes its diagnostic sequence in Our Approach. Regen.MD's joint dysfunction materials note that many patients carrying the bone-on-bone label retain more functional cartilage than the term implies, that radiographic narrowing correlates only loosely with reported pain, and that roughly one in five knee replacement patients reports persistent pain after surgery. Related patient education is available in The Library , including "Bone on Bone Knee?" Why "Nothing Can Be Done" Is a Lie: Is Meniscus Surgery Worth It? What 10-Year Data Reveals, Orthobiologics in St. Louis: Repairing the System Instead of Silencing the Alarm, and Intradiscal PRP: The Protocol for Treating the Disc as Biology, Not Hardware. Further material appears in the Surgery Alternatives and Regenerative Treatments collections and under Patient Resources. How to Begin Regen.MD does not offer free consultations or introductory calls. Patients begin with a Clinical Evaluation — a structured diagnostic assessment that includes imaging review, ultrasound examination, and metabolic laboratory work — with a $400 non-refundable fee, initiated through the clinical application at regen.md. "Come and get a real evaluation," Dr. Padda said. "Let us look at your knee and your biology and tell you honestly whether you're a candidate for a regenerative bridge, or whether replacement really is your best next step. Either way, you finally have the truth and a choice. A knee replacement is a wonderful operation, but it is major, irreversible surgery with a finite lifespan, and the younger you have it, the more likely you are to outlive it. What the data offers is control of the timeline — the ability to decide when, or whether. A bridge isn't a smaller thing than a miracle. Sometimes it's the whole thing." About Regen.MD Regen.MD is a regenerative and metabolic medicine practice in St. Louis, Missouri, led by Gurpreet Padda, MD, MBA, who has worked for three decades at the intersection of interventional pain management, regenerative medicine, and metabolic biology. The practice treats chronic back pain, joint dysfunction, metabolic inflammation, and neuropathic pain through image-guided orthobiologic procedures — including intra-articular and intraosseous PRP — alongside laboratory-guided peptide protocols and metabolic optimization. Regen.MD is located at 4477 Woodson Rd, Suite 103, St. Louis, MO 63134, near St. Louis Lambert International Airport. Gurpreet Singh Padda, MD Regen.MD +1 314-668-1525 email us here Visit us on social media: YouTube The Lie of the End of the Road: Bone on Bone Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical Result

17 Jun 2026

·www.globenewswire.com

Cosmos Health Signs 2.86 Million-Unit Contract Manufacturing Agreement With Pharmex S.A. Across Three Dermatological Products

CHICAGO, June 17, 2026 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today announced that, through its wholly owned subsidiary Cana Laboratories S.A. ("Cana"), it has entered into a five-year contract manufacturing agreement with Pharmex S.A. ("Pharmex") to produce three pharmaceutical products. Under the agreement, Cana will manufacture the following products for Pharmex at its EU-GMP-licensed, EMA-certified facility, with combined volumes of approximately 2.86 million units over the five-year term. ProductActive IngredientPharmaceutical FormAnnual UnitsFive-Year TotalBETAFUSIN®Betamethasone, Fusidic AcidCream450,0002,250,000BOTAFEX®MinoxidilCutaneous Solution65,000325,000BUDESODERM®BudesonideCream / Cutaneous Solution57,000285,000Total 572,0002,860,000 The agreement reinforces Cosmos Health's role as a contract manufacturer of pharmaceutical products and supports higher utilization of its EU manufacturing capacity. By leveraging Cana's licensed production capabilities, the Company aims to deepen its long-term manufacturing partnerships and strengthen recurring revenue from its higher-margin contract manufacturing activities. Founded in 1981, Pharmex is a Greek pharmaceutical company with over 40 years in medicinal products and dermocosmetics. It develops and produces its own products and serves as the exclusive local distributor for international partners. Pharmex products are available in more than 20 countries across Europe, the Middle East, Asia, Africa and Latin America. Greg Siokas, CEO of Cosmos Health, stated: "This five-year agreement with Pharmex reflects the strength of our manufacturing platform and the trust that pharmaceutical partners place in Cana Laboratories. Contract manufacturing is an important pillar of our vertically integrated model, allowing us to maximize the value of our EU-licensed facilities while building stable, long-term relationships. We look forward to delivering for Pharmex and to expanding these partnerships over time.” About Cosmos Health Inc. Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, www.cloudscreen.gr, as well as LinkedIn and X. Forward-Looking StatementsWith the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could,” generally identify forward-looking statements, although not all forward-looking statements contain these words. These statements involve risks and uncertainties that may individually or materially affect the matters discussed herein for a variety of reasons outside the Company’s control, including, but not limited to: the Company’s ability to raise sufficient financing to implement its business plan; the effectiveness of its digital asset strategies, including accumulation and yield-generating activities; the impact of the war in Ukraine and ongoing conflicts in the Middle East and other regions on the Company’s business, operations, and the economy in general; the Company’s ability to successfully develop and commercialize its proprietary products and technologies; changes in interest rates; changes in foreign currency exchange rates, commodity or other price inflation and deflation; our ability to issue debt on terms and at rates acceptable to us; the impact and expected outcome of investigations, inquiries, claims, and litigation; the challenges of operating in international markets; the adequacy of insurance coverage; the effect of accounting charges and of adopting certain accounting standards; the impact of legal and regulatory changes, including changes to tax laws and regulations; guidance for fiscal 2026 and beyond and financial outlook. Forward-looking statements are based on currently available information and our current assumptions, expectations and projections about future events. You should not rely on our forward-looking statements. These statements are not guarantees of future performance and are subject to future events, risks and uncertainties – many of which are beyond our control, dependent on the actions of third parties, or currently unknown to us – as well as potentially inaccurate assumptions that could cause actual results to differ materially from our historical experience and our expectations and projections. These risks and uncertainties include, but are not limited to, those described from time to time in our periodic reports filed with the SEC and available at the SEC’s website (www.sec.gov). There also may be other factors that we cannot anticipate or that are not described herein, generally because we do not currently perceive them to be material. Such factors could cause results to differ materially from our expectations. Forward-looking statements speak only as of the date they are made, and we do not undertake to update these statements other than as required by law. You are advised, however, to review any further disclosures we make on related subjects in our filings with the Securities and Exchange Commission and in our other public statements. Investor Relations Contact:BDG Communicationscosm@bdgcommunications.com

Acquisition

05 May 2026

·www.biospace.com

LEO Pharma Delivers 9% Revenue Growth at CER in Q1 2026 and Strengthens Innovation Pipeline

BALLERUP, Denmark--(BUSINESS WIRE)--In Q1 2026, LEO Pharma delivered robust revenue growth, driven by the dermatology portfolio, and improved profitability while significantly increasing commercial investments to support the global roll-out of Anzupgo ® and the addition of Spevigo ® to the portfolio. LEO Pharma also made significant strategic progress and advanced innovation through the acquisition of Replay’s next-generation gene therapy platform targeting rare genetic skin diseases, the approval of Enstilar ® in China and the continued late-stage development activities for Anzupgo ® , including FDA acceptance for review in adolescents with chronic hand eczema. Financial highlights LEO Pharma’s revenue increased by 4% to DKK 3,521 million, and by 9% at constant exchange rates (CER). The revenue growth was led by North America (30% at CER) and Rest of World (13% at CER), whereas sales in Europe declined by 1% at CER. Revenue from the dermatology portfolio grew by 11% (CER), driven by the strategic brands Anzupgo ® , Spevigo ® and Adtralza ® /Adbry ® , which combined had a revenue increase of 43% (CER), in addition to growth of 1% (CER) in the established brands. Sales in the Critical Care portfolio grew by 3% (CER). Operating profit improved, with adjusted EBITDA increasing by 12% to DKK 610 million in Q1 2026. The adjusted EBITDA margin improved to 17% (Q1 2025: 16%) led by gross margin expansion to 65% (Q1 2025: 58%), offsetting higher commercial investments. Net profit for Q1 2026 was DKK 99 million (Q1 2025: DKK 1,742 million), including non-recurring items. Excluding non-recurring items, net profit improved by DKK 132 million to DKK 142 million in Q1 2026. Free cash flow was DKK 336 million for Q1 2026 (Q1 2025: DKK 1,386 million), and net interest-bearing debt was reduced to DKK 8,987 million (YE 2025: DKK 9,358 million). Excluding M&A, free cash flow improved by DKK 581 million compared to Q1 2025. Innovation highlights Acquisition of Replay, announced on 30 April 2026, adding a next-generation gene therapy platform for topical delivery in rare genetic skin diseases and further expanding LEO Pharma’s presence in rare dermatology. FDA accepted for review the label expansion sNDA for Anzupgo ® (delgocitinib) cream for adolescents aged 12 to 17 years with moderate to severe chronic hand eczema in the U.S. China’s NMPA approved Enstilar ® (calcipotriene/betamethasone dipropionate) foam for the treatment of plaque psoriasis in adults, expanding access to a new treatment option for more than an estimated 6 million adults in the country. 2026 outlook 2026 revenue growth of 8-11% (CER) is unchanged, while the adjusted EBITDA margin outlook is revised to 15-18% (previously: 16-19%) reflecting increased spending on development activities following the acquisition of Replay. "We are off to a robust start to 2026, with improved profitability and strong cash flow, while continuing to invest in our commercial capabilities to support future growth. With our agreement to acquire Replay, we are adding a next-generation gene therapy technology that further expands LEO Pharma’s presence in rare dermatology and supports our focus on advancing innovation and leveraging our global platform to address significant unmet patient needs.” CEO Christophe Bourdon About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,300 people worldwide. Together, we reach far beyond the skin. For more information, visit Contacts For further information please contact: I nvestor Relations: Christian Boas Ryom, telephone +45 4494 5888 Media: Jeppe Ilkjær, telephone +45 3050 2014

100 Deals associated with Betamethasone

External Link

KEGG	Wiki	ATC	Drug Bank
D00244	Betamethasone	D07XC01 A07EA04 R01AD06	DB00443

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Erythematosus, Discoid	United Kingdom	Organon & Co.	03 Jun 2021
Prurigo	Portugal	Organon & Co.	03 Jun 2021
Prurigo	United Kingdom	Organon & Co.	03 Jun 2021
Psoriasis	Netherlands	Organon & Co.	03 Jun 2021
Psoriasis	Sweden	Organon & Co.	03 Jun 2021
Psoriasis	Taiwan Province	Organon & Co.	03 Jun 2021
Psoriasis	United Kingdom	Organon & Co.	03 Jun 2021
Colitis, Ulcerative	Japan	Shionogi & Co., Ltd.	04 Jun 1981
Lupus Erythematosus, Cutaneous	China	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Dermatitis	Japan	Takada Corp.	20 Oct 1964
Drug Eruptions	Japan	Takada Corp.	20 Oct 1964
Rhinitis, Allergic	Japan	Takada Corp.	20 Oct 1964
Urticaria	Japan	Takada Corp.	20 Oct 1964
Asthma	Japan	Shionogi Pharma, Inc.	12 Dec 1961
Collagen Diseases	Japan	Shionogi Pharma, Inc.	12 Dec 1961
Endocrine System Diseases	Japan	Shionogi Pharma, Inc.	12 Dec 1961
Heart Failure	Japan	Shionogi Pharma, Inc.	12 Dec 1961
Hematologic Diseases	Japan	Shionogi Pharma, Inc.	12 Dec 1961
Nephrotic Syndrome	Japan	Shionogi Pharma, Inc.	12 Dec 1961
Rheumatoid Arthritis	Japan	Shionogi Pharma, Inc.	12 Dec 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ataxia Telangiectasia	Phase 2	-	Grace Therapeutics, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02939742 (CTgov)	Phase 2/3	Preterm Premature Rupture of the Membranes \| Respiratory Distress Syndrome in Premature Infants	33	betamethasone (Betamethasone)	kxgwicskzk(kfycbfyleo) = hofhlbcxth mwwzckipwg (ycdpawfcop, daadwwjmkc - hibzbusvuf) View more	-	30 Jun 2026
				Placebo (Saline Placebo)	kxgwicskzk(kfycbfyleo) = qstyswjmbb mwwzckipwg (ycdpawfcop, ijgfatfido - vgmkxfaopc) View more
NCT04278833 (CTgov)	Phase 4	Osteoarthritis \| Tendinopathy \| Shoulder Impingement Syndrome	165	Corticosteroid (Particulate Corticosteroid Injection - Shoulder Injection Site)	jcphbphtnx(ckjshpkajr) = ifhhowwnke qdwyxymczt (lggxegzdhs, 2.1) View more	-	12 Feb 2025
				Corticosteroid (Particulate Corticosteroid Injection - Hip Injection Site)	jcphbphtnx(ckjshpkajr) = ylzvwwgfbe qdwyxymczt (lggxegzdhs, 3.1) View more
NCT04900220 (CTgov)	Phase 4	Arthus Reaction \| Trigger Finger Disorder	66	Betamethasone (Betamethasone)	ovgkbybjki = byjiewjmru bypeyzuobq (fgsydxepnm, mzrnrzmiom - oydvgybolp) View more	-	23 Jun 2023
				Methylprednisolone (Methylprednisolone)	ovgkbybjki = kxebvfdtzx bypeyzuobq (fgsydxepnm, pqjujzrcjq - mferkrfkfn) View more
NCT02469519 (Pubmed \| Am J Obstet Gynecol MFM)	Not Applicable	Fetal Membranes, Premature Rupture	194	Booster antenatal corticosteroids	kyarixzobk(rwlkvicxuw) = wmsyyunyrz qycpxolmgv (cggoxioxap ) View more	Negative	13 Feb 2023
				Placebo	kyarixzobk(rwlkvicxuw) = mjbkjujqmk qycpxolmgv (cggoxioxap ) View more
NCT02038634 (CTgov)	Phase 4	Thyroiditis, Subacute	16	betamethasone (Unguided Injections)	ugehpscidq(zfvxfmsxvc) = pmzkxxzlxs eowyufnspn (juhazjzwqb, vefcidzsqw - ofnmzzvrjv) View more	-	28 Dec 2022
				Ultrasound+betamethasone (Ultrasound-guided Injections)	ugehpscidq(zfvxfmsxvc) = swwnnpabys eowyufnspn (juhazjzwqb, kwomjscxvk - nbofsuvtrh) View more
NCT04420572 (CTgov)	Not Applicable	Greater Trochanteric Pain Syndrome	63	ozone injection (Ozone Injection Group)	gshirkykhj(eogaovkadt) = strkiiecme pxgvxnttzu (irekhylkto, 1.06) View more	-	21 Oct 2021
				betamethasone (Steroid Injection Group)	gshirkykhj(eogaovkadt) = iicfxrvrwj pxgvxnttzu (irekhylkto, 0.95) View more
NCT02749799 (CTgov)	Phase 4	Plaque psoriasis	45	betamethasone dipropionate+DFD-01	ihghhbuckg(zofvwyzomj) = hqtfwmiskx zgaqbnwvyp (unqanzechk, 0.77) View more	-	05 Oct 2020
NCT00669383 (CTgov)	Not Applicable	-	85	A (Betamethasone) (A (Betamethasone))	aygcrfstsd(udrnjxqgrf) = pbnqosmnvs lxybgoshte (qarvuanxjb, 8.8) View more	-	22 Feb 2019
				Placebo (B (Placebo))	aygcrfstsd(udrnjxqgrf) = hurdbzkzeg lxybgoshte (qarvuanxjb, 7.9) View more
NCT01222247 (ALPS, CTgov)	Phase 3	Pregnancy \| Respiratory Distress Syndrome \| Obstetric Labor, Premature	2,831	betamethasone (Betamethasone)	qinnblarsl = daqydbfiny jighfpoopp (ogoopjljht, pmubcldylm - ikdttgsapl) View more	-	30 Jan 2019
				Placebo (Placebo)	qinnblarsl = mvpkkmopwt jighfpoopp (ogoopjljht, ihhmfxnkwm - aocwgpffge) View more
NCT00669383 (Pubmed \| J Pediatr)	Not Applicable	Infant, Premature, Diseases	-	Rescue Antenatal Steroids	bhwjupqcxm(uwbpmweqiw) = ifhdtnjqkf jtwvmdowin (atqxixycsu )	-	01 Feb 2017
				Placebo	bhwjupqcxm(uwbpmweqiw) = xucxtctltk jtwvmdowin (atqxixycsu )

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