To comparative evaluation of the effect of local application of somatropin growth hormone on osseointegration and bone density around dental implant clinical and radiographic study - NIL

开始日期2025-03-15

申办/合作机构-

NCT05746650

/ RecruitingN/AIIT

Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury

The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.

开始日期2023-02-24

申办/合作机构

Bispebjerg Hospital

NCT03091374

/ Active, not recruiting临床2期IIT

A Proof-of-concept Study to Assess the Effect of Recombinant Human Growth Hormone on the Size of the Replication-competent Viral Reservoir in HIV-infected Individuals on Suppressive Antiretroviral Therapy

Antiretroviral therapy (ART) has improved the health of more than 18 million people infected with HIV by controlling viral replication, AIDS and non-AIDS events, and by reducing the risk of transmission. However, the existence of latent viral reservoirs in long-lived memory CD4 T cells remains a hurdle to curing HIV infection; consequently patients must remain on ART for the rest of their lives. Recently, a more realistic approach under limelight is to identify strategies leading to a functional cure, which is defined as the natural control of viral reservoir by the host. Use of recombinant human growth hormone has been shown to improve immune function by several mechanisms. This study hypothesizes that treatment with recombinant human growth hormone will decrease the size of the replication competent HIV reservoir in HIV-infected immune-reconstituted individuals.
The specific study objectives include:
* To evaluate the effect of recombinant human growth hormone administration for 48 weeks on the size of the replication competent HIV reservoir
* To evaluate the safety and tolerability of recombinant human growth hormone administration for 48 weeks in HIV-infected individuals on suppressive ART.
For this purpose, the investigators will add recombinant human growth hormone treatment for the patients receiving stable ART. Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada), which will last about 52 weeks. Participants will be treated with recombinant human growth hormone for a total of 48 weeks. The initial recombinant human growth hormone dose will be 3 mg/day (30-40 µg/kg/d) for 24 weeks administered by subcutaneous injection on an outpatient basis, followed by dose reduction to 1.5 mg/day for the final 24 weeks of the treatment period, also conducted on an outpatient basis. The study inclusion criteria include male and female participants, ≥18 and <40 years of age, with an undetectable viral load (the quantity of the HIV virus in the blood must be less than 50 copies/ml) during last 24 months and with a CD4 T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. The findings from this study will contribute to the development of novel strategies to eradicate HIV.

开始日期2016-12-01

申办/合作机构

Centre universitaire de santé McGill

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项与生长激素(Merck Serono SA) 相关的文献（医药）

2025-01-01·PLoS One

Persistence with daily growth hormone among children and adolescents with growth hormone deficiency in Japan.

Article

作者: Wajnrajch, Michael P ; Benjumea, Darrin ; Jhingran, Priti ; Wogen, Jenifer ; Alvir, Jose ; Takasawa, Kei ; Chen, Yong ; Loftus, Jane

BACKGROUND:

Pediatric growth hormone deficiency (pGHD) is treated with daily somatropin (recombinant human growth hormone) injections. High rates of discontinuation and poor adherence to treatment, which are associated with worse growth outcomes, have been documented previously, for example in the US and Europe. Discontinuation of somatropin has not yet been evaluated using real-world data in Japan.

OBJECTIVES:

To describe discontinuation of, and persistence to, daily somatropin treatment among children with pGHD in Japan.

METHODS:

This was a retrospective cohort study of children (≥3 and <16 years old) who were prescribed somatropin, using 2 Japan-based databases, Japan Medical Data Center (JMDC) and Medical Data Vision (MDV). Children were required to have ≥1 prescription for somatropin (first prescription = index date) within each study period (1 January 2002-30 September 2021 for JMDC and 1 January 2009-31 October 2021 for MDV) and ≥1 GHD diagnosis code without a somatropin prescription during the 6-months pre-index period. Children were required to be continuously enrolled in the database ≥6 months preceding and ≥3 months following index date. Children were followed for up to 48 months post-index. Early persistence was defined as the proportion of children with ≥1 refill of somatropin subsequent to the initial prescription. Discontinuation was defined as the first observation of a gap in therapy (using >60, > 90, and 120-day gap thresholds) between successive somatropin prescription fill dates. Persistence was defined as continuous refills of somatropin with no gaps in therapy. Time to discontinuation/non-persistence was evaluated using Kaplan-Meier methods, and Cox proportional hazards models identified predictors of time to discontinuation. This analysis utilized de-identified patient data from 2 large, Japanese-based retrospective databases; as such this study does not meet the requirements for institutional review board (IRB) review.

RESULTS:

Among the children included in this study (JMDC N = 452, MDV N = 573), most were male (JMDC 64.8%, MDV 60.0%). Mean age (standard deviation) was 8.8 (3.6) years in JMDC and 7.5 (3.6) years in MDV. Early persistence was high across both cohorts (JMDC 91.2%, MDV 83.4%). Using the 90-day gap definition for discontinuation, a sizable proportion of children discontinued over the follow-up period: JMDC 19% at 12 months, 35% at 48 months; and MDV 33% at 12 months, 54% at 48 months. Fewer discontinuations were observed with the 120-day gap definition (~16% at 48 months in JMDC, ~ 28% at 48 months in MDV) and more were observed with the 60-day gap definition (~67% at 48 months in JMDC, ~ 83% at 48 months in MDV). No meaningful predictors of discontinuation were identified.

CONCLUSIONS:

Despite high early persistence with somatropin, many children with pGHD in Japan were increasingly non-persistent over time: at 48 months post-index, at least 16% of children discontinued therapy, using the JDMC database and the most conservative measure of gap allowance. These results suggest a need for new strategies to support somatropin medication use over time among children with pGHD in Japan.

2025-01-01·HUMAN REPRODUCTION

Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial

Article

作者: Tadevosyan, Artak ; Mourad, Ali ; Phillips, Simon ; Jamal, Wael ; Hemmings, Robert ; Kadoch, Isaac-Jacques

Abstract:

STUDY QUESTION:

Does adjuvant growth hormone (GH) therapy in GnRH antagonist cycles improve reproductive outcomes in the general IVF population?

SUMMARY ANSWER:

Empiric adjuvant GH therapy in GnRH antagonist cycles does not improve IVF stimulation results or reproductive outcomes, including implantation, miscarriage, and clinical pregnancy rates.

WHAT IS KNOWN ALREADY:

Previous evidence regarding the benefits of GH therapy in IVF cycles has been inconclusive due to the lack of well-designed, large-scale randomized controlled trials (RCTs) in the general IVF population.

STUDY DESIGN, SIZE, DURATION:

This is a phase III open-label RCT involving 288 patients undergoing antagonist IVF cycles at the Ovo clinic in Montreal, Canada, between June 2014 and January 2020. Patients were randomly assigned at a 1:1 ratio to either the GH or control group. The intervention group received daily 2.5 mg subcutaneous injections of GH from Day 1 of ovarian stimulation until the day of oocyte retrieval, while the control group received standard ovarian stimulation without any adjuvant therapy.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Patients were expected normal responders. All embryo transfers, both fresh and frozen, resulting from the studied IVF cycle were included in an intention-to-treat and per-protocol analyses. The primary outcome was the clinical pregnancy rate, while secondary outcomes included the number of retrieved oocytes, good-quality embryos, maturation, fertilization, implantation, and miscarriage rates.

MAIN RESULTS AND THE ROLE OF CHANCE:

A total of 288 patients were recruited and randomly assigned at a 1:1 ratio to either the GH or the control group. After excluding cycle cancellations and patients who did not undergo transfer, 105 patients remained in each group. The overall mean age was 38.0 years, the mean BMI was 25.11 kg/m2 and the mean anti-Müllerian hormone was 2.51 ng/ml. The cycle characteristics were similar between both groups. No differences were observed regarding the total dose of gonadotropins (4600 versus 4660 IU for the GH and control groups, respectively, P = 0.752), days of stimulation (11.4 versus 11.7 days, P = 0.118), and endometrial thickness (10.63 versus 10.94 mm, P = 0.372). Both the intention to treat (ITT) and per protocol analyses yielded similar results for stimulation outcomes. In the ITT analysis, no differences were found in the number of follicles ≥15 mm (7.8 versus 7.1, P = 0.212), retrieved oocytes (11.7 versus 11.2, P = 0.613), mature oocytes (8.5 versus 8.6, P = 0.851), maturation rate (73.8 versus 78.4%, P = 0.060), fertilization rate (64.3 versus 67.2%, P = 0.388), and good quality embryos (2.5 versus 2.6, P = 0.767). Reproductive outcomes in fresh embryo transfer showed no difference for implantation rate (38.2 versus 39.5%, P = 0.829), miscarriage rate (26.5 versus 31.1%, P = 0.653), clinical pregnancy rate (43.6 versus 50.0%, P = 0.406, rate difference, 95% CI: −0.06 [−0.22, 0.09]), and live birth rate (32.1 versus 33.3%, P = 0.860). The number of embryos needed to achieve a clinical pregnancy was 3.0 versus 2.5 in the GH and control groups, respectively. Similarly, reproductive outcomes in first frozen embryo transfer showed no difference for implantation rate (31.6 versus 45.3%, P = 0.178), miscarriage rate (28.6 versus 26.3%, P = 0.873), clinical pregnancy rate (35.1 versus 44.2%, P = 0.406, P = 0.356, rate difference, 95% CI: −0.09 [−0.28, 0.10]), and live birth rate (22.8 versus 32.6%, P = 0.277). The number of embryos needed to achieve a clinical pregnancy was 3.1 versus 2.4 in the GH and control groups, respectively.

LIMITATIONS, REASONS FOR CAUTION:

The study focused on expected normal responders, limiting its applicability to other patient populations such as poor responders.

WIDER IMPLICATIONS OF THE FINDINGS:

These findings suggest that adding GH therapy to ovarian stimulation in GnRH antagonist cycles may not benefit the general IVF population. Additional high-quality RCTs are warranted to identify subgroups of patients who might benefit from this treatment.

STUDY FUNDING/COMPETING INTEREST(S):

EMD Serono Inc., Mississauga, Canada, supplied Saizen® for the study, free of charge. In addition, they provided funding for the statistical analysis. I-J.K. declares grants or contracts from Ferring Pharmaceuticals, consulting fees from Ferring Pharmaceuticals, honoraria from Ferring Pharmaceuticals and EMD Serono, support for attending meetings or travel from Ferring Pharmaceuticals and EMD Serono, participation on a Data Safety Monitoring Board or Advisory Board for Ferring Pharmaceuticals, and stock or stock options from The Fertility Partners; W.J. declares support for attending meetings or travel from EMD Serono; and S.P. declares stock or stock options from The Fertility Partners. All other authors have no conflicts of interest to disclose.

TRIAL REGISTRATION NUMBER:

NCT01715324.

TRIAL REGISTRATION DATE:

25 October 2012.

DATE OF FIRST PATIENT’S ENROLMENT:

25 June 2014.

2024-11-15·MEDICINE

A retrospective study of recombinant human growth hormone in the treatment of school-aged pediatric patients with idiopathic short stature

Article

作者: Li, Yun-Hai ; Zhang, Xue-Rong ; Chen, Yao

The present study aims to investigate the clinical efficacy of recombinant human growth hormone (r-hGH) in the treatment of school-age pediatric patients with idiopathic short stature (ISS). Pediatric patients who were diagnosed with ISS and treated with r-hGH at our hospital were enrolled as research subjects. The main outcome indicators included the serum level of insulin-like growth factor-1, insulin-like growth factor binding protein-3, baseline height standard deviation scores, and posttreatment height standard deviation scores and retrospective analysis was performed. This study complies with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. A total of 42 pediatric patients with a diagnosis of ISS were enrolled in the present study (24 males and 18 females). Following treatment, the levels of insulin-like growth factor-1 and insulin-like growth factor binding protein-3 were significantly higher than the baseline level and the difference was statistically significant. The posttreatment height standard deviation scores was significantly higher than the baseline height standard deviation scores and the difference was statistically significant. There were no significant differences between male and female participants in height standard deviation scores, either before or following treatment. This study found that r-hGH therapy may increase height in school-age pediatric patients with ISS and is therefore worthy of clinical application.

项与生长激素(Merck Serono SA) 相关的新闻（医药）

2025-07-29

·Pharmaceutical Technology

Ascendis Pharma’s Skytrofa gains FDA approval for growth hormone deficiency

The therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin. Credit: Andrei Kuzmik / Shutterstock.com. The US Food and Drug Administration (FDA) has granted approval for Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH), a prodrug of somatropin or human growth hormone (HGH), to treat adults with growth hormone deficiency (GHD). GHD is characterised by a decrease or complete lack of production of endogenous growth hormone. Skytrofa was previously approved by the FDA in 2021 to treat children and paediatric patients aged one year or above weighing at least 11.5kg and are experiencing growth failure due to inadequate secretion of endogenous growth hormone (GH). It is a sterile, preservative-free lyophilised powder that appears white to off-white, available in a single-dose, dual-chamber prefilled cartridge. This therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin. The FDA’s approval for adults with GHD was based on the findings from the Phase III parallel-arm, randomised, active-controlled (open-label) and placebo-controlled (double-blind) foresiGHt trial. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence It evaluated the safety and efficacy of weekly TransCon hGH in comparison to a weekly placebo and daily somatropin in adults diagnosed with GHD. Ascendis Pharma president and CEO Jan Mikkelsen said: “Our market research shows Skytrofa is the treatment of choice for paediatric GHD among patients and physicians, and we are pleased to expand its availability in the US for the treatment of adults initiating therapy or switching from another growth hormone therapy. “This important milestone is the first of many planned label expansions supporting our goal to become the leading endocrinology rare disease company.” Last year, the company submitted a supplemental biologics licence application to the FDA for TransCon hGH to treat adults with GHD. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

临床3期上市批准临床结果

2025-07-28

·PipelineReview

FDA Approves SKYTROFA® (Lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone Deficiency

COPENHAGEN, Denmark I July 28, 2025 I Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA ® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. The FDA’s approval of SKYTROFA for adult GHD was based on results from foresiGHt, a Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) clinical trial that compared the efficacy and safety of weekly TransCon hGH with weekly placebo and daily somatropin in adults with GHD. “The abnormal body composition, dyslipidemia, and insulin resistance that are the hallmarks of adult GHD predispose affected individuals to serious medical complications such as metabolic syndrome, increased cardiovascular risk, and impaired quality of life – including cognitive dysfunction, depression, anxiety, sleep disturbance, and reduced physical and mental drive. Despite this, adherence to daily somatropin injections that have been the standard of care for more than 25 years remains a problem,” said Kevin Yuen, M.D., Barrow Neurological Institute, University of Arizona College of Medicine and Creighton University School of Medicine in Phoenix, Arizona. “It is no surprise that patients are looking for a less burdensome treatment regimen, and a new treatment option such as SKYTROFA, with once-weekly injection and its unique release of unmodified somatropin, is expected to help improve both real-world adherence and overall outcomes.” “Our market research shows SKYTROFA is the treatment of choice for pediatric GHD among patients and physicians, and we are pleased to expand its availability in the United States for the treatment of adults initiating therapy or switching from another growth hormone therapy,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “This important milestone is the first of many planned label expansions supporting our goal to become the leading endocrinology rare disease company.” The following information is intended for the U.S. Audience Only: IMPORTANT SAFETY INFORMATION & USES SKYTROFA is a prescription medicine used for: Do not take SKYTROFA if: Tell your healthcare provider if you are pregnant or plan to become pregnant, about all of your medical conditions, and about all the medicines you take. SKYTROFA may affect how other medicines work, and other medicines may affect how SKYTROFA works. What are the possible side effects of SKYTROFA? SKYTROFA may cause serious side effects, including: The most common side effects of SKYTROFA in children include: viral infection, fever, cough, nausea and vomiting, bleeding, diarrhea, stomach area pain, joint pain and arthritis The most common side effects of SKYTROFA in adults include: swelling due to fluid build-up and low thyroid hormone These are not all of the possible side effects of SKYTROFA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch . You may also report side effects to Ascendis Pharma at 1-844-442-7236. Please click here for SKYTROFA full Prescribing Information. About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. * ISS = idiopathic short stature SHOX deficiency = short stature homeobox-containing gene deficiency SGA = small for gestational age SOURCE: Ascendis Pharma

临床3期上市批准临床结果

2025-06-09

·EINPresswire

TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial

- For the TransCon CNP treatment-naïve cohort, combination treatment resulted in mean annualized growth velocity (AGV) of 9.14 cm/year, with an improvement in mean ACH height Z-score of +0.53 over 26 weeks - For the TransCon CNP-treated cohort, combination treatment resulted in mean AGV of 8.25 cm/year, with an improvement in mean ACH height Z-score of +0.44 over 26 weeks - The combination of TransCon hGH and TransCon CNP demonstrated accelerated improvement in body proportionality at Week 26, aligning with the increase in linear growth - Safety and tolerability data consistent with those observed for TransCon hGH and TransCon CNP monotherapies; combination treatment was generally well tolerated, with generally mild treatment-emergent adverse events (TEAEs) - Ascendis to host conference call today at 8:00 am ET COPENHAGEN, Denmark, June 09, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced Week 26 interim analysis results from its ongoing COACH Trial, the first clinical trial to evaluate combination treatment with once-weekly investigational TransCon CNP (navepegritide) and once-weekly TransCon hGH (lonapegsomatropin) in children with achondroplasia. Results demonstrated that TransCon hGH boosted treatment benefits of TransCon CNP, resulting in significant growth and proportionality improvements in children with achondroplasia after 26 weeks of combination treatment, with a safety and tolerability profile consistent with those observed for TransCon hGH and TransCon CNP monotherapies. TransCon CNP, which is under priority review as a monotherapy for children with achondroplasia by the U.S. Food & Drug Administration (FDA), is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly, providing continuous exposure of active CNP to receptors on tissues throughout the body, including growth plates and skeletal muscle. TransCon hGH is a prodrug of somatropin administered once weekly, providing sustained release of active, unmodified somatropin. TransCon hGH is approved and marketed as SKYTROFA ® for the treatment of pediatric growth hormone deficiency and is in development for other indications. “TransCon CNP as a monotherapy has demonstrated the potential to transform the treatment of achondroplasia, and the COACH Trial at Week 26 demonstrates that TransCon hGH has the potential to boost treatment benefits of TransCon CNP with a safety profile consistent with monotherapies,” said Aimee Shu, M.D., Executive Vice President of Endocrine & Rare Disease Medical Sciences and Chief Medical Officer at Ascendis Pharma. “These results highlight the unique portfolio of once-weekly TransCon CNP and once-weekly TransCon hGH, with complementary modes of action, to improve the treatment landscape for growth disorders and physical functioning.” COACH Trial Design The COACH Trial is an ongoing proof-of-concept prospective Phase 2 open-label trial to investigate the efficacy, safety, and tolerability of combined treatment with once-weekly TransCon CNP at 100 µg/kg/week and once-weekly TransCon hGH at 0.30 mg/kg/week in children with achondroplasia aged 2 to 11 years. The trial included a cohort of TransCon CNP treatment naïve children (N=12, mean age 4.67 years) and a cohort of TransCon CNP-treated children (N=9, mean age 7.89 years) who had received TransCon CNP (100 µg/kg/week) for a mean of 2.56 years in clinical trials. The trial population is representative of children with achondroplasia, except for the observed growth benefit in the TransCon CNP-treated cohort. The interim analysis will be followed by Week 52 data, expected in Q4 2025, and Ascendis plans to initiate a Phase 3 trial in Q4 2025. Highlights of the Interim Topline Week 26 COACH Trial Results For TransCon CNP treatment-naïve children, mean annualized growth velocity (AGV) was 9.14 cm/year, representing an increase from baseline at Week 26 of 4.23 cm/year, with an improvement in mean ACH height Z-score of +0.53 over 26 weeks. For TransCon CNP-treated children, mean AGV was 8.25 cm/year, representing an increase from baseline at Week 26 of 3.10 cm/year, with an improvement in mean ACH height Z-score of +0.44 over 26 weeks. Mean AGV with TransCon CNP and TransCon hGH combination treatment exceeded the 97th percentile of average-stature children. Children treated with TransCon hGH and TransCon CNP demonstrated accelerated improvement in body proportionality at Week 26, aligning with the increase in linear growth. Bone age advanced in line with chronologic age. Safety and tolerability data were consistent with those observed for TransCon hGH and TransCon CNP monotherapies; combination treatment was generally well tolerated, with generally mild TEAEs. A slide presentation with these data can be found on the Investor Relations & News section of the Ascendis Pharma website: https://investors.ascendispharma.com . Conference Call and Webcast Information Ascendis Pharma will host a conference call and webcast today at 8:00 am Eastern Time (ET) to discuss these results. Those who would like to participate may access the live webcast here , or register in advance for the teleconference here . The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com . A replay of the webcast will be available on that page shortly after the conclusion of the event for 30 days. About Achondroplasia Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 people worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, causing serious muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia vary across different stages of life. Throughout infancy and childhood, observed complications include spinal deformities, enlarged brain ventricles, impaired muscle strength and stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; many of these persist or worsen in adulthood. These medical complications can have detrimental effects on quality of life, physical functioning, and psychosocial function. Individuals with achondroplasia often require multiple surgeries and procedures to alleviate the condition’s many complications. About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) TransCon CNP’s potential to transform the treatment of achondroplasia, (ii) TransCon hGH’s potential to boost treatment benefits of TransCon CNP with a safety profile consistent with monotherapies, (iii) the potential for the combination of TransCon CNP and TransCon hGH to improve the treatment landscape for growth disorders and physical functioning, (iv) the expected timing of Week 52 data from the COACH Trial and Ascendis’ plans to initiate a Phase 3 trial in Q4 2025, (v) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, and (vi) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, SKYTROFA, and TransCon are trademarks owned by the Ascendis Pharma group. © June 2025 Ascendis Pharma A/S. Investor Contacts: Media Contact: Sarada Weerasinghe Melinda Baker Ascendis Pharma Ascendis Pharma ir@ascendispharma.com media@ascendispharma.com Patti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com 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.

临床结果临床2期优先审批临床3期

100 项与生长激素(Merck Serono SA) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
成长不全	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
性腺发育不全	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
生长迟缓	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
特纳综合症	澳大利亚	Merck Healthcare Pty Ltd.	2011-08-22
短肠综合征	美国	EMD Serono, Inc.	2001-11-19
生长激素缺乏症	美国	EMD Serono, Inc.	1996-10-08
HIV感染	美国	EMD Serono, Inc.	1996-08-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
特发性矮小症	临床3期	美国	Merck KGaA	2012-12-01
不孕	临床3期	加拿大	EMD Serono, Inc.	2012-06-01
纤维肌痛	临床3期	西班牙	Merck KGaA	2007-12-01
垂体性侏儒症	临床3期	美国	EMD Serono, Inc.	2005-01-01
HIV相关性脂肪营养不良综合征	临床3期	美国	EMD Serono, Inc.	2004-05-28
HIV相关性脂肪营养不良综合征	临床3期	加拿大	EMD Serono, Inc.	2004-05-28
小于胎龄儿	临床3期	意大利	Merck KGaA	2004-02-01
胎儿生长受限	临床3期	-	Merck KGaA	1998-11-01
HIV消耗综合征	临床3期	-	EMD Serono, Inc.	1997-07-01
软骨发育不良	临床2期	法国	Merck KGaA	2006-03-21

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01111019 (CTgov)	临床2期	软骨发育不良	19	Recombinant human growth hormone (r-hGH)	淵艱蓋艱憲構齋淵選繭(憲膚膚鏇壓觸簾鑰構鏇) = 構網鹹繭鏇憲築鬱淵鑰製範繭糧醖醖鬱願窪選 (願衊鏇鏇顧觸鬱選繭餘, 0.9) 更多	-	2019-02-15
NCT00082628 (CTgov)	临床3期	HIV相关性脂肪营养不良综合征	326	Placebo (Period I: Placebo)	窪餘鹹簾鬱壓襯願築膚(顧餘願獵選醖積壓餘願) = 繭醖壓鹽遞構選膚廠簾餘獵蓋鹽鏇膚簾簾願襯 (窪齋膚齋顧蓋繭鏇醖選, 34.5) 更多	-	2018-07-20
				Serostim® 4 mg (Period I: Serostim® 4 mg)	窪餘鹹簾鬱壓襯願築膚(顧餘願獵選醖積壓餘願) = 鬱襯蓋餘齋鑰蓋積鬱醖餘獵蓋鹽鏇膚簾簾願襯 (窪齋膚齋顧蓋繭鏇醖選, 37.9) 更多
NCT00256126 (CTgov)	临床4期	特纳综合症 \| 生长激素缺乏症	318	Saizen (Turner Syndrome (TS))	糧積鏇襯窪糧願襯壓憲(艱繭獵範繭夢膚齋簾繭) = 艱製遞鏇簾淵艱壓膚襯選鬱築夢鬱醖鹹衊簾積 (繭膚構鑰夢憲構衊憲鹹, 1.1889) 更多	-	2018-03-20
				Saizen (Growth Hormone Deficiency (GHD))	糧積鏇襯窪糧願襯壓憲(艱繭獵範繭夢膚齋簾繭) = 構網築醖餘鏇遞廠鬱遞選鬱築夢鬱醖鹹衊簾積 (繭膚構鑰夢憲構衊憲鹹, 0.9811) 更多
NCT01806298 (CTgov)	临床4期	生长激素缺乏症	78	Saizen®	糧觸糧顧願膚齋夢簾繭 = 鹽遞襯願範構夢糧醖網鹽製獵範膚齋壓獵糧窪 (遞夢廠壓遞衊選蓋鬱鹹, 範鬱簾範顧鹽餘選鏇顧 ~ 鑰簾餘鏇醖醖簾鬱鏇艱) 更多	-	2017-04-04
NCT01746862 (SYNERGY, CTgov)	临床3期	特发性矮小症	90	Saizen® (Saizen Test Group)	網蓋觸遞廠窪願衊鹹襯(醖窪觸艱製範廠網築齋) = 鹹積窪構鏇選襯顧觸襯醖餘遞構壓獵遞範窪艱 (齋壓淵製夢襯築獵選網, 1.62) 更多	-	2016-10-18
				Saizen® (Saizen Control Group)	網蓋觸遞廠窪願衊鹹襯(醖窪觸艱製範廠網築齋) = 鬱淵廠鏇憲鹹窪簾願憲醖餘遞構壓獵遞範窪艱 (齋壓淵製夢襯築獵選網, 1.91) 更多
NCT00933686 (CTgov)	临床3期	纤维肌痛	113	Saizen® (Saizen®)	餘壓齋襯淵築憲窪壓餘 = 願選鹽壓憲鹹醖夢選淵糧膚鹽製窪鹽鏇鏇獵顧 (鑰積膚壓夢膚鑰繭夢鬱, 鑰壓壓積構鑰顧廠願夢 ~ 艱膚糧選醖糧願窪窪構) 更多	-	2013-08-02
				Placebo+Saizen® (Placebo + Saizen®)	餘壓齋襯淵築憲窪壓餘 = 糧製選積淵願鹹繭膚願糧膚鹽製窪鹽鏇鏇獵顧 (鑰積膚壓夢膚鑰繭夢鬱, 繭範遞築夢繭齋餘醖範 ~ 選鏇鑰簾選鬱餘艱壓鹹) 更多
NCT01237340 (CTgov)	临床3期	生长激素缺乏症	59	Saizen®	製構夢憲憲遞繭廠餘觸 = 顧糧鑰鬱鹹選顧膚網醖獵艱製壓糧鹽淵襯蓋鹽 (醖窪憲築鹽觸醖顧簾齋, 顧顧鹽選艱襯遞蓋鏇艱 ~ 鑰鏇鏇襯製齋蓋構製觸) 更多	-	2012-10-11
NCT00249821 (SGA OPTIMIS, CTgov)	临床3期	小于胎龄儿	22	Saizen® (Saizen® 0.057 mg/kg/Day)	遞醖鏇鹹觸壓襯選齋觸(繭範壓選繭製簾窪繭鹹) = 鏇範鏇範鹹蓋艱鏇醖窪簾夢遞淵夢遞顧範壓繭 (繭獵繭廠膚獵餘蓋艱遞, 1.35) 更多	-	2012-10-10
				Saizen® (Saizen® 0.035 mg/kg/Day)	遞醖鏇鹹觸壓襯選齋觸(繭範壓選繭製簾窪繭鹹) = 憲壓顧網糧淵窪蓋淵窪簾夢遞淵夢遞顧範壓繭 (繭獵繭廠膚獵餘蓋艱遞, 1.15) 更多
NCT00100698 (CTgov)	N/A	脂肪营养不良 \| 获得性免疫缺陷综合征	56	Growth Hormone (Recombinant Human Growth Hormone)	蓋齋鏇築襯積廠廠築製(餘艱夢夢遞願獵鹽壓範) = 積遞構齋範範願夢窪築膚膚遞顧鑰壓觸餘簾鬱 (淵夢築廠遞積廠繭廠淵, 6) 更多	-	2010-07-22
				placebo (Placebo)	蓋齋鏇築襯積廠廠築製(餘艱夢夢遞願獵鹽壓範) = 鹹鑰鹽簾鬱鬱積獵鹽襯膚膚遞顧鑰壓觸餘簾鬱 (淵夢築廠遞積廠繭廠淵, 4) 更多
NCT01077960 (CTgov)	临床3期	HIV感染	126	Serostim	淵簾積網鬱窪顧鹽鑰範(蓋積築夢鹹簾醖衊窪鹹) = 鑰簾選鏇壓鹹鏇鹹鬱襯糧築選夢窪鹽獵餘鑰膚 (鏇積遞餘鬱齋製膚鹽鑰, 1.4) 更多	-	2010-06-23