The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally. The study will evaluate biomarkers for epigenetic aging and immunosenescence, as well as evaluate established clinical measures and risk factors for prevention of physical frailty, cancer, cardiovascular disease, diabetes, dementia, and also infectious diseases, including flu and COVID-19.
The study uses multiple agents in combination with personalized doses of recombinant human growth hormone (somatropin), metformin, and DHEA, in a similar manner to how the combination treatment was applied in the earlier TRIIM trial at Stanford, which demonstrated strong statistical significance for the primary efficacy endpoints that will be evaluated in TRIIM-X. Somatropin is approved by the FDA for adult growth hormone deficiency and its use in the study is guided by prior safety data established for that use and also based on safety data available on its prior use in the TRIIM trial and in clinical practice in healthy elderly individuals. There will also be control groups that enable testing of biomarker variability and the contribution of individual medications within the combination treatment.
The objective of the study is to obtain information needed for designing an effective personalized and adaptive treatment regimen for a larger and more diverse study population, and to obtain additional proof of principle for the new use of the medications and biomarkers for preventive medicine. The duration of treatment in the TRIIM-X trial will be 12 months.

Start Date23 Nov 2020

Sponsor / Collaborator

Intervene Immune, Inc.

IRCT2015070210599N4 / CompletedPhase 2IIT

Comparison of intra-articular injection of platelet rich plasma (PRP) versus combined PRP/somatropin on pain and joint range of motion in patients with knee osteoarthritis

Start Date22 Jun 2015

Sponsor / Collaborator-

NCT01438801 / WithdrawnPhase 4

Predictive Value of Baseline and Stimulated Serum IGF-1 and IGFBP-3 During a Dose-escalation IGF-1 Generation Test for the 1 Year Growth Response to Growth Hormone (GH) Therapy in Short Children With Low IGF-1 and a Normal GH Peak in a Provocation Test

The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).

Start Date01 May 2013

Sponsor / Collaborator

Ipsen SA

100 Clinical Results associated with Somatropin(Genentech, Inc.)

100 Translational Medicine associated with Somatropin(Genentech, Inc.)

100 Patents (Medical) associated with Somatropin(Genentech, Inc.)

240

Literatures (Medical) associated with Somatropin(Genentech, Inc.)

01 Feb 2024·Current medical research and opinion

Health-related quality of life in pre-pubertal children with pediatric growth hormone deficiency: 12-month results from a phase 3 clinical trial of once-weekly somatrogon versus once-daily somatropin

Article

Author: Valluri, Srinivas Rao ; Quitmann, Julia ; Loftus, Jane

OBJECTIVE:

Treatment of pediatric growth hormone deficiency (pGHD) with daily injection of recombinant human growth hormone (somatropin) aims to increase height velocity and improve health-related quality of life (HRQoL). The Quality of Life in Short Stature Youth (QoLISSY) questionnaire was administered in a phase 3 clinical trial that evaluated efficacy and safety of once-weekly somatrogon versus once-daily somatropin in children with pGHD (ClinicalTrials.gov no NCT02968004).

METHODS:

Treatment-naïve prepubertal children with pGHD received once-weekly somatrogon or once-daily somatropin for 12 months. The QoLISSY core module (physical/social/emotional subscales) was administered at baseline and 12 months after treatment initiation. QoLISSY-Parent was completed by parents/caregivers of children <7 years old and some parents/caregivers of children ≥7 years old; children ≥7 years old self-completed QoLISSY-Child.

RESULTS:

Baseline characteristics were similar between treatment groups (N = 117). Among children <7 years old, QoLISSY-Parent total and subscale scores showed similarly improved HRQoL at 12 months relative to baseline in both treatment groups. Self-reported QoLISSY-Child total and subscale scores in children ≥7 years old indicated HRQoL improvements at 12 months that were numerically better with somatrogon than somatropin (similar results with QoLISSY-Parent in this age group). At both time points, children reported better HRQoL than perceived by their parents/caregivers.

CONCLUSION:

Treatment for 12 months with once-weekly somatrogon or once-daily somatropin resulted in comparable improvements in HRQoL among children with pGHD. Lower HRQoL perceived by parents/caregivers possibly reflect children's tendency to emphasize adaptation. These results suggest that evaluation of HRQoL could help support treatment decisions in children with pGHD treated with growth hormone.

31 Dec 2023·Journal of medical economics

Cost-effectiveness and cost-utility analysis of somatrogon once-weekly injections vs. daily growth hormone injection for treating paediatric growth hormone deficiency in Ireland

Article

Author: Kongnakorn, Thitima ; Rivolo, Simone ; Fahey, Marion ; Peter, Balazs ; Loftus, Jane

OBJECTIVES:

Paediatric growth hormone deficiency (pGHD) manifests as growth failure associated with inadequate growth hormone (GH) production. Daily injections of recombinant human GH (dGH) [somatropin] is the current standard of care, which has been shown to be well tolerated and effective, but associated with suboptimal adherence, leading to reduced effectiveness. Somatrogon, a once-weekly injectable long-acting human GH, has demonstrated clinical non-inferiority and significantly lower life interference (i.e. treatment burden) vs. somatropin in two Phase 3 studies. This work evaluated cost-effectiveness and cost-utility of somatrogon vs dGHs from an Irish payer perspective.

METHODS:

A Markov model was developed for patients starting somatrogon or dGHs treatment at 3-12 years and continuing up to achievement of near adult height (NAH), with growth driven by trial-based height velocity (HV) and treatment-specific adherence. Patients could discontinue treatment at the end of Year 1 (4%). DGH adherence (95.3%-65% over treatment duration) and adherence-growth relationship were based on published evidence. Higher Year 1 adherence of 4%, tapering over time, for somatrogon vs. dGHs was based on clinical consultation. Treatment costs, monitoring costs and costs due to different wastage types (device setting and adherence) were sourced from local data. Health utilities based on height and injection frequency were derived from published literature. Scenario analysis, deterministic and probabilistic sensitivity analysis were performed.

RESULTS:

Somatrogon treatment led to 1.87-3.66 cm greater NAH gain and 0.21-0.50 higher quality adjusted life years (QALYs) vs. dGHs, across the base case and scenarios evaluated. Somatrogon treatment was associated with cost savings of €5,699-€21,974 and lower cost per cm gained vs. dGHs (€197-€527), per patient. Somatrogon was cost-effective vs. dGHs, with the result consistent across the sensitivity analyses conducted.

CONCLUSION:

Somatrogon weekly injections were estimated to result in higher NAH, higher QALYs, lower overall costs and lower costs per cm gained than dGHs, in pGHD.

01 Dec 2023·Drug safety

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Review

Author: Cohen, Hillel P ; Kottke, Andrea ; Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar

BACKGROUND:

Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.

METHODS:

Post-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).

RESULTS:

The combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.

CONCLUSIONS:

This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

News (Medical) associated with Somatropin(Genentech, Inc.)

28 Aug 2024

·firstwordpharma.com

Pfizer launches virtual platform to help patients navigate the US healthcare system

Pfizer announced on Tuesday the launch of PfizerForAll, a virtual health platform designed to streamline health services and resources for Americans, including filling prescriptions and receiving help with co-pays to save money on Pfizer medicines.PfizerForAll offers vaccination appointment scheduling, access to same-day in-person and telehealth appointments, home delivery of prescriptions and diagnostic tests, migraine managements, and patient support services nationwide. Patients will be able to access services from UpScriptHealth, Alto Pharmacy and Instacart in addition to existing insurance and pharmacy programs.The list of medications Pfizer provides for savings assistance includes Cibinqo (abrocitinib), Genotropin (somatropin) and Ibrance (palbociclib). The latter is a breast cancer medication whose price rose nearly 7% in 2022, and analysts have pegged it as a likely target for future rounds of Medicare price negotiations. The company’s prostate cancer drug Xtandi was the subject of criticism several years ago for its high cost to patients, though it was not included as an option under PfizerForAll cost savings assistance. This launch aims to help people navigate the complexities and “roadblocks” in the US healthcare system. The company’s Executive Vice President and Chief US Commercial Officer Aamir Malik described the US healthcare system’s current gaps as “time-consuming” and overwhelming for patients, leading to indecision and therefore “poor health outcomes.”Malik remarked, “We are pleased to offer PfizerForAll to help relieve this burden on people, especially as we enter the fall season in the US, and streamline the path for those seeking better health.”

08 Mar 2024

·www.prnewswire.com

VISEN Announces Acceptance of a Biologics License Application for Lonapegsomatropin in China

SHANGHAI, March 7, 2024 /PRNewswire/ -- VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, today announced that the Biologics License Application (BLA) for Lonapegsomatropin (TransCon hGH) was accepted by the China National Medical Products Administration (NMPA). Lonapegsomatropin is the first once-weekly administrated growth hormone approved by both the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of Pediatric Growth Hormone Deficiency (PGHD). Mr. Pony LU, CEO of VISEN Pharmaceuticals, said, "As the first upcoming commercial product of VISEN Pharmaceuticals, lonapegsomatropin has demonstrated statistically significantly greater efficacy than the daily hGH in the Chinese Phase 3 clinical results. The BLA acceptance represents a significant step towards the product commercialization. We believe that by continuously focusing on providing first-in-class or best-in-class products and treatments, we could provide Chinese endocrine patients with innovative therapies and achieving better treatment processes and outcomes." Lonapegsomatropin is a prodrug of somatropin administered once weekly. By leveraging the innovative technology platform TransConTM (transient conjugation), it is designed to provide sustained release of active, unmodified somatropin, the same growth hormone used in daily pediatric GHD treatments. The unmodified, unbound somatropin released from lonapegsomatropin has the identical 191 amino-acid sequence and size (22 kDa) as endogenous growth hormone. Lonapegsomatropin and TransCon technology are owned and developed by Ascendis Pharma A/S. VISEN Pharmaceuticals holds exclusive rights to develop, manufacture and commercialize lonapegsomatropin in the Greater China. Approval No.: COMU2024029/EN/PR About VISEN Pharmaceuticals VISEN is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' need first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market, and have established offices in Shanghai, Beijing, Hong Kong and Taipei. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier. For more information, please visit our website: Contact us: [email protected] SOURCE VISEN Pharmaceuticals (VISEN)

Drug ApprovalPhase 3Clinical ResultNDA

15 Jan 2024

·www.prnewswire.com

Chronic Disease Markets for Sustained Released Injectables: The Trend toward Self-Administration

DUBLIN, Jan. 15, 2024 /PRNewswire/ -- The "Chronic Disease Markets for Sustained Released Injectables" report has been added to ResearchAndMarkets.com's offering. The report provides a comprehensive evaluation and analysis of the technology, products and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, disease segments, and commercial opportunities for chronic disease markets for sustained release injectables. Provider organization business managers, healthcare administrators and investors will also benefit from this study. Evolving Engineered Solutions Chronic conditions require drug administration over long periods of time, placing a greater emphasis on self-administration. With the shift away from caregiver interaction, drug safety and compliance/adherence become prominent concerns. These concerns, which are not new, are becoming magnified as the number of powerful new drugs reaching the market increases. For healthcare managers and public health officials, one way to address these issues is less frequent dosing. Using formulation technologies designed to modulate the effect of therapeutic substances, drug developers are creating formulations that exhibit extended-release profiles. These chemistries include polymers such as polyethylene glycol-complexed (PEGylated), which are used to product encapsulated and coated versions of new APIs. The goal is to address the requirement for patient-dependent, and therefore compliance-sensitive, drug treatment protocols such as multiple dosing through controlled release formulations that provide the desired therapeutic effect with dosing of once-a-day or less. What You Will Learn What are the marketed sustained release injectable drug products, what sustained release formulation technologies are used, and who markets them? What are the major factors driving sustained release injectable drug demand? What sustained release injectable drug candidates are in late-stage clinical development and what is their potential impact? How important are drug developer-formulation technologist relationships in the sustained release market segment, and what are the key alliances in the industry? What are the essential formulation factors, delivery device selection issues, related technology factors and market development issues for sustained release injectable drug products? In what therapeutic market segments do sustained release injectables compete? What is their market share today? What will it be in 2028? What is their expected growth rate? What are the significant economic, technology, and regulatory factors affecting the market for sustained release injectables? Key Topics Covered: Injectable Drug Market Dynamics The Trend toward Self-Administration Injectable Drug Formulation Technology Innovation in Injectable Device Designs Therapeutic Demand Drivers Market Factors Competitive Landscape Risk Factors Sustained Release - Branded Formulation Technologies Biodegradable Polymers Branded SR Formulation Technologies Physical Process Control Methods Sustained Release Injectables - Development Factors Formulation Factors Stability Lyophilization Packaging Administration Factors SR Injectables - Product Analysis & Market Sector Forecasts Addiction Naltrexone Diabetes Exenatide Infectious Disease Interferon Hormone Deficiency Estradiol Somatropin Testosterone Metabolic Diseases Acromegaly Neurology Oncology Leukemia Lymphoma Cytarabine Prostate Pain Management Reproductive Health Fertility Endometriosis Market Profiles Companies Mentioned Alkermes Amylin AntriaBio Ascendis Pharma AstraZeneca Aurobundo Avadel Biomarin Camurus Critical Pharmaceuticals DURECT Eli Lilly Enzon Ipsen Janssen NanOlogy Novartis OctoPlus Oakwood Laboratories/PharmaSophia Pacira PhaseBio Pharmaceuticals Recipharm AB Roche Sanofi Taiwan Liposome Company Xbrane Bipharma For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with Somatropin(Genentech, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Renal function impairment with growth failure	EU	Ipsen Pharma SAS	15 Feb 2001
Renal function impairment with growth failure	IS	Ipsen Pharma SAS	15 Feb 2001
Renal function impairment with growth failure	LI	Ipsen Pharma SAS	15 Feb 2001
Renal function impairment with growth failure	NO	Ipsen Pharma SAS	15 Feb 2001
Dwarfism	US	Genentech, Inc.	29 Dec 1995
Idiopathic short stature	US	Genentech, Inc.	29 Dec 1995
Chronic Kidney Diseases	US	Genentech, Inc.	09 Mar 1994
Growth Disorders	US	Genentech, Inc.	09 Mar 1994
Growth hormone deficiency	US	Genentech, Inc.	09 Mar 1994
Turner Syndrome	US	Genentech, Inc.	09 Mar 1994

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	US	Genentech, Inc.	01 Feb 2006
Pituitary Diseases	Phase 3	BE	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	CZ	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	DK	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	FI	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	FR	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	DE	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	GR	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	IT	Ipsen SA	01 Jun 2004
Pituitary Diseases	Phase 3	RO	Ipsen SA	01 Jun 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2021	Not Applicable	Growth hormone deficiency	201	Adherent to daily somatropin therapy	mlurbzsyfh(kjvfaflukx) = jksbdqiphj yoiqwzsyil (nqxoubsqdz, 8.9 - 9.9)	-	22 Sep 2021
				Non-adherent to daily somatropin therapy	mlurbzsyfh(kjvfaflukx) = zsymwsclcy yoiqwzsyil (nqxoubsqdz, 6.6 - 8.5)
NCT00455728 (iNCGS, ESPE2018)	Not Applicable	Growth Disorders \| Growth hormone deficiency	2,792	NutropinAq ®	aurfntucfg(njxmwsvfmr) = Seven deaths occurred, all considered not related to NutropinAq ® bigsjbtjey (dzfbmojtgk ) View more	-	27 Sep 2018
NCT00234533 (OPTIMA, CTgov)	Phase 3	Dwarfism \| Turner Syndrome \| Pituitary Diseases	251	Somatropin (rDNA origin)	cmtpkoapga(rtwgwlzuiv) = tuwsnnsdyp uqqxuqgadd (cijrtoqiqx, sbejasdqad - sonywufewg) View more	-	09 Aug 2018
ESPE2014	Not Applicable	Central Nervous System Cysts	12	rhGH	klbnkivkui(zkgnpnhtvh) = voezbhmoxl ziddxibbdr (fvrbpgdkel ) View more	Positive	18 Sep 2014
ESPE2014	Not Applicable	Dwarfism, Pituitary exon 3 deleted (d3-GHR) genetic polymorphism of GH receptor (GHR)	111	Recombinant Human GH	xhfoaxypyu(iumfgtoidz) = bpwbmhbmls eibkzsslhk (fsejxemsbz ) View more	-	18 Sep 2014
				Recombinant Human GH	xhfoaxypyu(iumfgtoidz) = zpsudkwehb eibkzsslhk (fsejxemsbz ) View more
ESPE2014	Not Applicable	Inflammatory Bowel Diseases	13	rhGH group	cdqjgptpln(glvxwlpwun) = fywkqdpapv gltldrruau (esjecedici )	-	18 Sep 2014
				Recombinant Human GH	cdqjgptpln(glvxwlpwun) = woyyryezoc gltldrruau (esjecedici )
NCT00283595 (CTgov)	Phase 2	Binge-Eating Disorder \| Osteoporosis \| Anorexia Nervosa	21	Growth Hormone (Recombinant Human Growth Hormone Group)	brdqsgfgen(dexmxeikpu) = lyfgqrfzre gnvyfcqidk (kjraqvfnrw, ayjmisbbsc - lcxpbkbggz) View more	-	16 Oct 2012
				Placebo (Placebo Group)	brdqsgfgen(dexmxeikpu) = wbvenblapp gnvyfcqidk (kjraqvfnrw, cexyfbnxvp - izdwranizx) View more

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