A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.

Start Date04 Oct 2023

Sponsor / Collaborator

Novo Nordisk A/S

CTR20230084 / Active, not recruitingPhase 3

一项在篮式研究设计中比较 somapacitan 每周一次给药与Norditropin® 每日给药在出生时小于胎龄儿或患有特纳综合征、努南综合征或特发性身材矮小的矮身材儿童中的有效性和安全性，以及评估 somapacitan 长期安全性的研究

[Translation] A study to compare the efficacy and safety of once-weekly somapacitan with daily Norditropin® in a basket study design in children born small for gestational age or with short stature due to Turner syndrome, Noonan syndrome, or idiopathic short stature, and to evaluate the long-term safety of somapacitan

本研究的目的是了解与Norditropin®相比，Somapacitan用于治疗出生时体型偏小且持续偏小，或患有特纳综合征、努南综合征，或特发性身材矮小的儿童的疗效如何。

[Translation]

The aim of this study was to find out how well somapacitan works compared to Norditropin® in children who are born small and remain small, or who have Turner syndrome, Noonan syndrome, or idiopathic short stature.

Start Date10 Feb 2023

Sponsor / Collaborator

Novo Nordisk China Pharmaceuticals Co. Ltd.

[+1]

NCT05718570 / Enrolling by invitationNot Applicable

A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Start Date03 Feb 2023

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Somapacitan

100 Translational Medicine associated with Somapacitan

100 Patents (Medical) associated with Somapacitan

7,739

Literatures (Medical) associated with Somapacitan

15 Feb 2024·Spine

Beyond Growth Hormone

Article

Author: Chen, Xibang ; Leng, Huijie ; Pan, Xiangxiang ; Wu, Yaosen ; Hu, Jiasheng ; Hong, Haofeng ; Huang, Chongan ; Zhang, Xiaolei ; Xu, Honghao ; Xia, Dongdong ; Chen, Jiaoxiang ; Guo, Quanquan ; Zhang, Shuhao ; Wang, Xiangyang

Study Design.:

Cross-sectional and retrospective cohort study.

Objective.:

We investigated the effect of 3 types of short stature [partial growth hormone deficiency (GHD), GHD, and idiopathic short stature (ISS)] and recombinant human growth hormone (rhGH) therapy on scoliosis.

Summary of Background Data.:

In short stature, rhGH is widely used and the concentration of growth hormone varies among types. The epidemiologic characteristics of scoliosis and the role of rhGH in scoliosis remain unclear.

Patients and Methods.:

A cross-sectional study was conducted among 3896 patients with short stature (partial GHD, GHD, and ISS), and a 1:1 age and sex-matched control group with preexisting whole-spine radiographs. The cohort study included 2605 subjects who underwent radiography more than twice to assess scoliosis development, progression, and the need for bracing and surgery. Adjusted logistic regression was used to assess differences in the prevalence of scoliosis among patients with partial GHD, GHD, ISS, and controls. The Kaplan-Meier method was used to analyze the time course of scoliosis development and progression. Cox regression was applied to assess the independent factors related to scoliosis development and progression. Mendelian randomization analyses were also performed.

Results.:

Compared with controls, patients with short stature had a higher incidence of scoliosis (34.47% in partial GHD, 31.85% in GHD, 32.94% in ISS vs. 8.83% in control, P < 0.001), a higher risk of scoliosis development [hazard ratio (HR) = 1.964 in partial GHD, P < 0.001; HR = 1.881 in GHD, P = 0.001; HR = 1.706 in ISS, P = 0.001), but not a higher risk of progression, brace, or surgery. Among the 3 types of short stature, there were no differences in the incidence, development, and progression of scoliosis or the need for bracing or surgery. RhGH treatment increased the risk of scoliosis development in each short-stature group (HR = 2.673 in partial GHD, P < 0.001; HR = 1.924 in GHD, P = 0.049; HR = 1.564 in ISS, P = 0.004). Vitamin D supplementation was protective against scoliosis development (HR = 0.456 in partial GHD, P = 0.003; HR = 0.42 in GHD, P = 0.013; HR = 0.838 in ISS, P = 0.257).

Conclusions.:

More attention should be paid to the spinal curve in patients with partial GHD, GHD, or ISS. For short stature treated with rhGH, the risk of scoliosis development was increased. Vitamin D supplementation may be beneficial for prevention.

Level of Evidence::

Level III.

01 Feb 2024·Clinica chimica acta; international journal of clinical chemistry

Molecular diagnosis is an important indicator for response to growth hormone therapy in children with short stature

Article

Author: Yang, Wanling ; Zhang, Chuanpeng ; Ban, Bo ; Zhao, Qianqian ; Li, Yanying ; Shao, Qian ; Zhang, Mei ; Wei, Wei ; Zhang, Yanhong

BACKGROUND:

Significant differences have been observed in the efficacy of recombinant human growth hormone (rhGH) treatment for short children. The present study aimed to identify the genetic etiology of short stature and to assess the role of molecular diagnosis in predicting responses to rhGH treatment.

METHODS:

A total of 407 short children were included in the present study, 226 of whom received rhGH treatment. Whole-exome sequencing (WES) was conducted on short children to identify the underlying genetic etiology. Correlations between molecular diagnosis and the efficacy of rhGH treatment were examined.

RESULTS:

Pathogenic or likely pathogenic mutations were identified in 86 of the 407 patients (21.1%), including 36 (41.9%) novel variants. Among the multiple pathways affecting short stature, genes involved in fundamental cellular processes (38.7%) play a larger role, especially the RAS-MAPK pathway. In general, patients without pathogenic mutations responded better to rhGH than those with mutations. Furthermore, patients with hormone signaling pathway mutations had a better response to rhGH, while those with paracrine factor mutations had a worse response to rhGH.

CONCLUSIONS:

This study highlights the utility of WES in identifying genetic etiology in children with short stature. Identifying likely causal mutations is an important factor in predicting rhGH response.

01 Feb 2024·Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

Growth hormone and testosterone delay vertebral fractures in boys with muscular dystrophy on chronic glucocorticoids

Article

Author: Loscalzo, Emely ; Yousefzadeh, Nazanin ; Wu, Malinda ; See, Julia ; Gough, Ethan ; Crane, Janet L ; Bharill, Sonum

PURPOSE:

Glucocorticoids prolong ambulation in boys with Duchenne muscular dystrophy; however, they have significant endocrine side effects. We assessed the impact of growth hormone (GH), testosterone, and/or zoledronic acid (ZA) on vertebral fracture (VF) incidence in patients with dystrophinopathies on chronic glucocorticoids.

METHODS:

We conducted a longitudinal retrospective review of 27 males with muscular dystrophy. Accelerated failure time (AFT) models were used to estimate the relative time to VF while on GH, testosterone, and/or ZA compared to ZA alone. Results are reported as failure time ratio, where >1 indicates prolonged time versus <1 indicates shorter time to next VF.

RESULTS:

The prevalence of growth impairment was 96% (52% utilized GH), pubertal delay was 86% (72% utilized testosterone), and low trauma fractures were 87% (72% utilized ZA). Multivariable analysis of the AFT models showed that participants on either GH or testosterone treatment relative to ZA alone experienced prolonged time to next VF (1.253, P<0.001), with GH being the significant contributor when analyzed independently from testosterone (1.229, P<0.001). Use of ZA with GH or testosterone relative to ZA alone resulted in prolonged time to next VF (1.171, P<0.001), with testosterone being a significant contributor (1.130, P=0.033).

CONCLUSION:

GH and testosterone each decreased VF risk in patients independent of or in combination with ZA, respectively.

News (Medical) associated with Somapacitan

17 Jun 2024

·www.biospace.com

Kaida BioPharma to Present at the Virtual Investor Pitch Conference

Live webcast on Monday, June 17th at 9:00 AM ET FORT LAUDERDALE, FL, June 17, 2024 (GLOBE NEWSWIRE) -- Kaida BioPharma (“Kaida” or the “Company”), an early-stage pharma company dedicated to advancing ovarian cancer treatment through innovative drug development, today announced that it will present at the Virtual Investor Pitch Conference today, June 17, 2024 at 9:00 AM ET. As part of the event, Craig Pierson, Founder and Chairman of Kaida BioPharma, will provide an “elevator pitch” and outline the Company’s upcoming milestones. Additionally, investors and interested parties will have the opportunity to submit questions live during the event. Participating companies will answer as many questions as possible in the time allowed. A live video webcast will be accessible on the event website, virtualinvestorco.com. A webcast replay will be available two hours following the live event and will be accessible for 90 days. About Kaida BioPharma Kaida BioPharma was founded on the research principles and clinical evidence of G129R, a growth hormone antagonist that has shown to induce programmed cell death (autophagy) in gynecologic tumors. Our collaboration with Dr. John Langenheim, professor at Thomas Jefferson University and Dr. Anil Sood at MD Anderson, who have published extensive research on G129R, has provided solutions we intend to bring to the clinic. At Kaida, we are dedicated to providing a new hope for patients with treatment-resistant gynecological cancers. Our mission is to develop innovative therapies that target the specific needs of those patients, offering a medical treatment that can make a significant difference. For more information, please visit kaida-biopharma.com. Investor Contact Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247 E: kaida@jtcir.com

04 Jun 2024

·www.globenewswire.com

Lumos Pharma Announces New Analyses of Phase 2 OraGrowtH212 Trial Presented at ENDO 2024

AUSTIN, Texas, June 04, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced today details of new analyses of data from its Phase 2 OraGrowtH212 clinical trial presented in two posters at the 2024 Annual Meeting of the Endocrine Society (ENDO), held in Boston, MA, June 1-4, 2024. The posters were presented in parallel sessions on Monday June 3, 2024. “The new analyses of data from our OraGrowtH212 Trial further characterized LUM-201’s unique ability to augment the natural pulsatile secretion of growth hormone, producing comparable growth to injectable rhGH with significantly less exposure to circulating growth hormone,” said John C. McKew, PhD, President and Chief Scientific Officer of Lumos Pharma. “The presented results also provide additional support for our planned approach to a placebo-controlled Phase 3 trial of LUM-201 in moderate PGHD, a trial design proposed by the FDA as an appropriate option for oral LUM-201 given its differentiated mechanism as a growth hormone secretagogue.” In the poster MON-111, titled, Oral LUM-201 Restores Pulsatile Growth Hormone Secretion and Growth Response in Moderate Pediatric Growth Hormone Deficiency (PGHD): Key Discoveries from Phase 2 of OraGrowtH212 Trial (Cassorla, F, et al) [poster link], investigators evaluated growth hormone pulsatility data obtained at baseline and at six months following treatment with LUM-201. Results showed that at six months on LUM-201, a significant increase over baseline in key parameters was observed for the 1.6 mg/kg/day dose. At baseline GH secretion was 0.19 ±0.09 μg/kg/12-hrs; pulsatile GH was 1.17 ±0.66 μg/kg/12-hrs; and total GH was 1.35 ±0.66 μg/kg/12-hrs.At 6 months each parameter increased significantly: GH secretion to 0.36 ±0.21 μg/kg/12-hrs, pulsatile GH to 1.8 ±0.74 μg/kg/12-hrs, and total GH to 2.2 ±0.89 μg/kg/12-hrsA similar level of increase was observed in the 3.2 mg/kg/day dose cohortInvestigators combined data from both dose cohorts and conducted a deconvolution analysis on GH secretion. It was determined that at six months GH secretion was 3.3 ±1.8 to 4.4 ±2.1 μg/kg/day compared to 5.0 ±1.3 μg/kg/day derived from published data in normal children, indicating restoration of approximately normal GH secretion by LUM-201.Conclusion – at 6 months LUM-201 was able to restore endogenous GH pulsatile secretion to a similar level seen in normal children while also normalizing serum IGF-1 concentrations. Results indicate that by restoring endogenous GH secretion, LUM-201 facilitates growth utilizing a much lower amount of GH than that provided by daily exogenous rhGH. By providing an oral therapy that attains physiological GH profiles, investigational LUM-201 treatment aligns with the fundamental objectives of endocrine therapies, specifically the restoration of normal hormonal homeostasis. In a late-breaking poster (MON-704) titled, Growth Response to Oral Growth Hormone Secretagogue LUM-201 in Children with Moderate GH Deficiency (GHD) is Dependent on the Pattern of Pulsatile GH Secretion Stimulated by LUM-201 (Stevens, A, et al), [poster link], investigators evaluated pulsatile GH profiles and growth response to LUM-201. Data from OraGrowtH212 pulse assessments at Day 1 (D1) and at 6 months (M6) were analyzed utilizing a univariate Spearman’s rank correlations matrix to screen for relationships between D1 characteristics, D1 height velocity, 6M Annualized Height Velocity and interpulse, pulsatile, and total GH secretion at D1 and M6.The 12-hour pattern of pulsatile secretion was characterized using Functional Principal Component Analysis (FPCA) to identify dominant modes of variation in the functional data. Subjects were grouped into tertiles based on 6M AHV. The 12-hour profiles were grouped into three 4-hour intervals.Results: All parameters increased from D1 to M6D1 pulsatile GH secretion was positively associated with D1 AHVWhile 6M AHV increased compared to baseline, GH Secretion at D1 and M6 was not apparently correlated with 6M AHVIn the FPCA, difference in interquartile range (IQR) for mean GH secretion was highest in 0-4 hrs in subjects in the high and medium AHV tertiles, while subjects with low AHV at 6 months had the highest difference at 8-12 hours Conclusions – LUM-201 stimulates significant increases in GH secretion over 6 months in patients with moderate PGHD. The relationship between growth response and both the amount and pattern of pulsatile GH secretion, with the highest growth observed in OraGrowtH212 associated with greatest pulsatile activity early in the 12 hour profile. Restoring GH secretion with LUM-201 in moderate PGHD results in both an increase in the overall amount of GH, and importantly, an alteration of the pattern of the pulse profile, with distinct differences in these patterns between the best and lower responders. About Lumos Pharma Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. The Company was founded and is led by a management team with longstanding experience in rare disease drug development. Lumos Pharma’s lead therapeutic candidate, LUM-201, is a novel, oral growth hormone (GH) secretagogue, seeking to transform the ~$4.7B global GH market from injectable to oral therapy. LUM-201 is currently being evaluated in multiple Phase 2 clinical studies in Pediatric Growth Hormone Deficiency (PGHD) and has received Orphan Drug Designation in both the US and EU. For more information, please visit https://lumos-pharma.com/. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements of Lumos Pharma, Inc. that involve substantial risks and uncertainties. All such statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. A law that, in part, gives us the opportunity to share our outlook for the future without fear of litigation if it turns out our predictions were not correct. We are passionate about our business - including LUM-201 and the potential it may have to help patients in the clinic. This passion feeds our optimism that our efforts will be successful and bring about meaningful change for patients. Please keep in mind that actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We have attempted to identify forward-looking statements by using words such as “projected,” "upcoming," "will," “would,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” and similar references to future periods or the negative of these terms. Not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding the advancement of oral LUM-201 to Phase 3, the potential for LUM-201 to be the first oral therapeutic for PGHD, and any other statements other than statements of historical fact. We wish we were able to predict the future with 100% accuracy, but that just is not possible. Our forward-looking statements are neither historical facts nor assurances of future performance. You should not rely on any of these forward-looking statements and, to help you make your own risk determinations, we have provided an extensive discussion of risks that could cause actual results to differ materially from our forward-looking statements including risks related to the timing and ability of Lumos Pharma to structure our Phase 3 trial in an effective and timely manner, the ability to initiate and advance a pivotal Phase 3 trial, as well as advance our clinical and corporate strategy in general, our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the ability to successfully develop our product candidate, the effects of pandemics, other widespread health problems or military conflicts including the Ukraine-Russia conflict and the Middle East conflict and other risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements including information in the "Risk Factors" section and elsewhere in Lumos Pharma’s Quarterly Report on Form 10-Q for the period ended September 30, 2023, as well as other subsequent reports filed with the SEC. All of these documents are available on our website. Before making any decisions concerning our stock, you should read and understand those documents. We anticipate that subsequent events and developments will cause our views to change. We may choose to update these forward-looking statements at some point in the future, however, we disclaim any obligation to do so. As a result, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Investor & Media Contact: Lisa MillerLumos Pharma Investor Relations512-792-5454ir@lumos-pharma.com Source: Lumos Pharma, Inc.

Phase 2Clinical ResultOrphan DrugPhase 1

30 May 2024

·www.globenewswire.com

Ascendis to Spotlight Latest Updates for TransCon™ Rare Endocrinology Disease Portfolio at ENDO 2024

COPENHAGEN, Denmark, May 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it will host informational booths, events, and presentations showcasing use of its innovative TransCon technology in the areas of growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome during ENDO 2024, the annual meeting of the Endocrine Society being held June 1-4, 2024, in Boston. “In addition to physician and caregiver presentations in pediatric GHD, we look forward to our first in-person opportunity to share data from foresiGHt, our pivotal trial of TransCon hGH in adults with GHD,” said Aimee Shu, M.D., Ascendis Pharma’s Senior Vice President of Clinical Development, Endocrine Medical Sciences. “And with World Hypoparathyroidism Day coinciding with the first day of ENDO, we are pleased to host an informational booth focused on deepening physician awareness of the significant health and quality-of-life impacts of hypoparathyroidism.” Ascendis presentations during ENDO 2024 include: Oral PresentationResults of the foresiGHt Trial Support the Efficacy and Safety of Once-Weekly Lonapegsomatropin in Adults with Growth Hormone DeficiencyBeverly M.K. Biller, M.D., Massachusetts General Hospital and Harvard Medical School OR36-04 June 3, 2:45 – 3:00 p.m ET.Ballroom 210B– BCEC Product TheaterPerspectives on a Once-Weekly Growth Hormone for Pediatric Growth Hormone DeficiencyPhilippe Backlejauw, M.D., Cincinnati Children’s Hospital and University of Cincinnati College of MedicineMike Gordon, Parent of a child living with growth hormone deficiency S102-09June 2, 9:30 – 10:30 a.m. ETScience Theater Exhibit Hall – Theater #2 Poster Presentation:Baseline Demographics and Design of the SkybriGHt Registry Study. A US Multi-Center, Prospective, Non-Interventional, Long-Term Effectiveness and Safety Study of Children and Adolescents with Growth Hormone Deficiency Treated with LonapegsomatropinPhilippe Backlejauw, M.D., Cincinnati Children’s Hospital and University of Cincinnati College of Medicine Poster MON-198 June 3, 12:00 – 1:30 p.m. ETPoster Hall/Reception About Ascendis Pharma A/SAscendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. 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) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company and (ii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. 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. 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 7, 2024 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, and TransCon are trademarks owned by the Ascendis Pharma group. © May 2024 Ascendis Pharma A/S. Investor Contacts:Media Contact:Tim LeeMelinda BakerAscendis PharmaAscendis Pharma+1 (650) 374-6343+1 (650) 709-8875tle@ascendispharma.commedia@ascendispharma.comir@ascendispharma.com Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com

100 Deals associated with Somapacitan

External Link

KEGG	Wiki	ATC	Drug Bank
D11194	-	H01AC01	DB15093

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Growth hormone deficiency	US	Novo Nordisk, Inc.	28 Aug 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dwarfism	Phase 3	US	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	CN	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	JP	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	AT	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	BE	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	BR	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	BG	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	CA	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	HR	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	FI	Novo Nordisk A/S	10 Aug 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03878446 (CTgov)	Phase 2	Dwarfism \| Small-for-dates baby	62	Somapacitan (Somapacitan 0.16 mg/kg/Week)	lhywqfzddv(seddeamosu) = neqmqcwuff dmvqufhlom (ywpchoknsx, qvuaqcuehy - idzfokckyw) View more	-	19 Jun 2024
				Somapacitan (Somapacitan 0.20 mg/kg/Week)	lhywqfzddv(seddeamosu) = hunzkfvave dmvqufhlom (ywpchoknsx, dwdmyxvypm - trdhsgcwif) View more
NCT03811535 (REAL4, ESPE2023)	Phase 3	Growth hormone deficiency IGF-I SDS	132	Once-weekly somapacitan 0.16 mg/kg/week	xkkjdzayfm(efwpvrcavg) = A low number of patients reported injection-site reactions in the second year, with no injection-site pain reported tfcomjeesv (pkbhbtyyod ) View more	Positive	21 Sep 2023
				Daily GH (0.034 mg/kg/day Norditropin)
NCT03811535 (Pubmed)	Phase 3	Growth hormone deficiency	200	Somapacitan	siedyqibmv(gjvzjbbypd) = lfoossopii pzttnysjrm (sukywthpmy )	-	05 Jul 2023
				Daily GH	siedyqibmv(gjvzjbbypd) = twberonifh pzttnysjrm (sukywthpmy )
NCT03878446 (ESPE2022)	Phase 2	Small-for-dates baby	62	Somapacitan 0.16 mg/kg/week	bljjbkaofc(bnmbgflcaa) = detected in one child in the GH 0.067 mg/kg/day arm; none were detected in other treatment arms tpsviwppbu (nrzhzktogt ) View more	-	15 Sep 2022
				Somapacitan 0.20 mg/kg/week
NCT03811535 (REAL4, Pubmed) Manual	Phase 3	Growth hormone deficiency	200	somapacitan	wrvwbsbzwl(uqvbolxfpk) = yzxswjopho qryowcoyvy (lhjkjlttcm ) View more	Similar	05 Sep 2022
				Recombinant Human Growth Hormone	wrvwbsbzwl(uqvbolxfpk) = moyzrakyoi qryowcoyvy (lhjkjlttcm ) View more
NCT02962440 (Pubmed \| Eur J Pharm Sci)	Phase 1	Dwarfism, Pituitary \| Growth hormone deficiency	7	Somapacitan 6 mg	ifltdydrbw(pqfhemhcjn) = Two subjects had six adverse events (AEs); all were mild in severity and unlikely to be related to trial product xkhuqnsdou (kshnywjtto )	-	30 Sep 2021
NCT03075644 (Pubmed \| Clin Endocrinol (Oxf)) Manual	Phase 3	Growth hormone deficiency	62	Somapacitan	gghgakuvuv(whbzeqzzxy) = xihepqmgam qimuykgznk (yalpzbpngq ) View more	Superior	01 Nov 2020
				GH	gghgakuvuv(whbzeqzzxy) = awtvvruhla qimuykgznk (yalpzbpngq ) View more
NCT03075644 (CTgov)	Phase 3	Growth hormone deficiency	62	somapacitan	ievnggouwd(mwbquxhyog) = pmuorugzmw qeritwdqmu (zwnmdbnqlw, etepkrefwe - gvqeskeujx) View more	-	06 Oct 2020
NCT02382939 (CTgov)	Phase 3	Growth hormone deficiency	92	somapacitan	ejwmhqxpzw(vozlkcevgd) = wtilmemthq dnyxpaqfmy (fpwdlitdxx, fvkxzjadpr - kyldshivmk) View more	-	16 Jun 2020
NCT02616562 (REAL 3, Pubmed \| J Clin Endocrinol Metab)	Phase 2	Dwarfism, Pituitary	59	Somapacitan 0.04mg/kg/week	girmguhprd(rstinlugrf) = enftzzjimk trcmordant (lybvprwoxs )	-	01 Apr 2020
				Somapacitan 0.08mg/kg/week	girmguhprd(rstinlugrf) = ielyhvdvmu trcmordant (lybvprwoxs )

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

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

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Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis