Clinical and radiographic outcomes of the modified minimally invasive surgical technique with or without platelet rich fibrin for the treatment of intrabony defects : a randomized clinical trial - M-MIST technique with or without PRF for intrabony defects treatment

Start Date28 Aug 2023

Sponsor / Collaborator-

CTRI/2023/06/054222 / Not yet recruitingPhase 3IIT

Evaluation of Morinda citrifolia(NONI) fruit extract powder in combination with I-PRF and I-PRF alone: A Randomized Controlled Trial.

Start Date30 Jun 2023

Sponsor / Collaborator-

CTRI/2023/06/053989 / Not yet recruitingNot ApplicableIIT

A Comparative evaluation of treatment outcomes of coronal pulpotomy using biodentine alone versus combination of PRF & biodentine in mature permanent mandibular molars diagnosed with irreversible pulpitis: a randomized controlled clinical trial

Start Date20 Jun 2023

Sponsor / Collaborator-

100 Clinical Results associated with Lanreotide Acetate

100 Translational Medicine associated with Lanreotide Acetate

100 Patents (Medical) associated with Lanreotide Acetate

1,860

Literatures (Medical) associated with Lanreotide Acetate

01 Dec 2024·CELL BIOCHEMISTRY AND BIOPHYSICS

Molecular Regulator Driving Endometriosis Towards Endometrial Cancer: A Multi-Scale Computational Investigation to Repurpose Anti-Cancer drugs

Article

Author: Al-Mazroua, Haneen A ; Mahema, S ; Ahmed, Shiek S S J ; Ahmad, Sheikh F ; Raman, Janaki ; Roshni, Jency

Endometriosis is a gynecological disorder among reproductive-aged women. Recent epidemiological investigations suggest endometriosis increases the risk of endometrial cancer. However, the molecular entity leading to endometriosis-to-endometrial cancer is largely unknown. This study aimed to combine a variety of computational approaches to identify the key therapeutic target promoting endometriosis-to-endometrial cancer and screen potential inhibitors against target to prevent cancer development. Our systematic investigations, includes transcriptomic profiling, protein network, pharmacophore modeling, docking, binding free energy calculation, dynamics simulation, and quantum mechanics. The gene expression analysis on endometriosis and endometrial cancer was performed and showed 108 shared upregulated genes in both conditions. Further construction of interaction network with 108 genes showed intercellular adhesion molecule 1 (ICAM1) to be a crucial molecule with a high degree of connectivity that influences vital mechanisms related to cancer pathways. We then generated ligand-based pharmacophore models using established ICAM1 inhibitors. Among the models, the ADRRR_8 pharmacophore exhibited a robust area under curve (AUC = 0.83), was employed to screen 1739 anti-cancer drugs. On screening, 421 anti-cancer drugs displayed ICAM1-inhibiting pharmacophore features. Further, the docking of 421 drugs with ICAM1 showed lanreotide (-7.80 kcal/mol) with better affinity than the reference ICAM1 inhibitor (-3.59 kcal/mol). Further validation though binding free energy and dynamics simulation of the lanreotide-ICAM1 complex showed a high binding affinity of -55.90 kcal/mol and contributed stable confirmation. According to quantum chemical calculations, lanreotide's electronic properties favour ICAM1 binding with highest occupied molecular orbital was -6.91 eV and lowest unoccupied molecular orbital was -3.93 eV. Our study supports using lanreotide to treat endometriosis, which could delay or prevent endometrial cancer. These predictions need to be confirmed and examined to determine the use of lanreotide in endometriosis treatment.

01 Dec 2024·ECOTOXICOLOGY AND ENVIRONMENTAL SAFETY

Human internal and external exposure to synthetic musks in China

Article

Author: Zhang, Xue ; Wang, Weijia ; Diao, Zishan ; Zhao, Xirui ; Zhao, Yameng ; Wan, Xu ; Zhang, Xiaohan ; Guo, Xiaohua ; Wang, Shuguang ; Yuan, Xianzheng ; Zhao, Jianhui ; Li, Wenpeng ; Wang, Zhenxin

The widespread utilization of synthetic musks (SMs) in various consumer and personal care products (PCPs) has led to human external exposure through dermal absorption, inhalation of volatile fragrances, and ingestion of contaminated foods, dust, and liquids. Nonetheless, investigations comparing external and internal exposures in humans remain limited in China, particularly regarding internal exposure assessments in blood, which have lacked follow-up over the past decade. In this study, data concerning the concentrations of SMs in 135 blood samples (68 females and 67 males) obtained from residents of Shanghai are provided, representing the sole publication within the last decade on this topic. The findings suggest a potential association between SM concentrations in females and their income and ages. Additionally, the concentrations in blood are higher than in urine, suggesting that relying solely on urine assessments may underestimate health risks associated with internal exposure. Furthermore, data on internal exposure in human fluids reveal SMs' potential transfer to infants via breast milk, posing substantial threat. Noteworthy, we quantify total external exposure across various pathways for Chinese population. Our findings indicate that PCPs are identified as the predominant source of external exposure for adolescents and adults. However, in the case of infants and children, food ingestion, and PCPs dermal absorption make substantial contributions, representing 80.53 % and 16.06 % of the total for infants, and 69.96 % and 22.40 % for children, respectively. Notably, the total estimated daily intake (EDI), derived from urine analysis, falls notably below the total external exposure. While the contribution of each SM exhibits considerable variability, which can be ascribed to the distinct metabolic pathways of these compounds in vivo. Hence, additional research on the metabolism and transformation of SMs in humans is urgently needed for better human health risk assessment in the future.

01 Dec 2024·INTERNATIONAL JOURNAL OF PHARMACEUTICS

A microfluidic in vitro method predicting the fate of peptide drugs after subcutaneous administration

Article

Author: Wanselius, Marcus ; Abrahmsén-Alami, Susanna ; Hanafy, Belal I. ; Hansson, Per ; Mazza, Mariarosa ; Hanafy, Belal I

For many biopharmaceuticals, subcutaneous (sc) administration is the only viable route. However, there is no in vitro method available accurately predicting the absorption profiles of subcutaneously injected pharmaceuticals. In this work, we show that a recently developed microfluidics method for interaction studies (MIS) has the potential to be useful in this respect. The method utilises the responsiveness of polyelectrolyte microgel networks to oppositely charged molecules as a means to monitor the interaction between peptides and hyaluronic acid (HA), a major constituent of the subcutaneous extracellular matrix. We use the method to determine parameters describing the strength of interaction between peptide and HA as well as the peptide's aggregation tendency and transport properties in HA networks. The results from MIS studies of the peptide drugs exenatide, pramlintide, vancomycin, polymyxin B, lanreotide, MEDI7219 and AZD2820 are compared with results from measurements with the commercially available SCISSOR system and in vivo absorption and bioavailability data from the literature. We show that both MIS and SCISSOR reveal differences in the peptides' diffusivity and tendency to aggregate in the presence of HA. We show that MIS is particularly good at discriminating between peptides forming aggregates stabilised by non-electrostatic forces in the presence of HA, and peptides forming complexes stabilised by electrostatic interactions with HA. The method provides two parameters that can be used to quantify the peptides' aggregation tendency, the one describing the peptide packing density in complexes with HA and the other the apparent diffusivity upon release in a medium of physiological ionic strength and pH. The order of the peptides when ranked by increasing binding strength at pH 7.4 determined with MIS is shown to be in agreement with the order when ranked by the apparent 1st order absorption rate constant (k_a) after sc administration in humans: lanreotide (Autogel) < exenatide (IRF) < AZD2820 < pramlintide < lanreotide (IRF) (IRF: Immediate release formulation). A correlation is found between the 1st order release rate constant determined with SCISSOR and k_a for lanreotide (Autogel), exenatide and AZD2820. A mechanism relating the magnitude of k_a to the peptides' charge is proposed.

News (Medical) associated with Lanreotide Acetate

23 Oct 2024

·www.globenewswire.com

Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance

PARIS, FRANCE, 23 October 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its performance for the year to date and the third quarter of 2024. YTD 2024 YTD 2023 % change Q3 2024 Q3 2023 % change €m €m Actual CER1 €m €m Actual CER1 Oncology 1 829,8 1 744,1 4,9% 5,8% 604,0 574,5 5,1% 5,6% Neuroscience 536,4 489,0 9,7% 11,8% 181,9 164,8 10,4% 10,1% Rare Disease 129,7 76,0 70,7% 71,3% 50,8 33,2 53,1% 54,4% Total Sales 2 495,9 2 309,1 8,1% 9,2% 836,6 772,4 8,3% 8,6% Highlights Total-sales growth in the year to date of 9.2% at CER1, or 8.1% as reported, with notable performances from Dysport® (abobotulinumtoxinA), Cabometyx® (cabozantinib) and Bylvay® (odevixibat), with robust Somatuline® (lanreotide) sales, as well as the increasing contribution from the launches of Iqirvo® (elafibranor) in 2L PBC2 and Onivyde® (irinotecan) in 1L mPDAC3 Regulatory approvals in the E.U. of Iqirvo and Kayfanda® (odevixibat)Increased 2024 financial guidance: total-sales growth greater than 8.0% at CER1 (prior guidance: greater than 7.0% at CER1); core operating margin greater than 31.0% of total sales (prior guidance: greater than 30.0%) “Since the launch of our strategy in 2020, we have enjoyed uninterrupted growth. This quarter was no exception and was accompanied by further progress in the pipeline”, commented David Loew, Chief Executive Officer. “We have also continued to launch across several indications and lines of therapy, including the recent rollouts of Iqirvo and Onivyde, which are progressing well. Supported by the performance so far this year, we are further increasing our 2024 sales and margin guidance.” “We have built a track record of delivery, grounded in a strong foundation of external innovation, commercial excellence and our ongoing mission to offer more choices for patients.” Full-year 2024 guidance Based on the strong performance in the third quarter, Ipsen has further increased its financial guidance for 2024: Total-sales growth greater than 8.0%, at constant currency (prior guidance of greater than 7.0%). Based on the average level of exchange rates in September 2024, an adverse impact on total sales of around 1.5% from currencies is expectedCore operating margin greater than 31.0% of total sales (prior guidance of greater than 30.0%) Pipeline update In September 2024, the European Commission conditionally approved Iqirvo 80mg tablets for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in patients unable to tolerate UDCA. Iqirvo was approved in the same setting by the U.S. FDA in June 2024. In September 2024, the European Commission also approved Kayfanda as a treatment for pruritus in children from as young as six months of age who have Alagille syndrome (ALGS). Odevixibat, under the brand name Bylvay, is already marketed in the E.U. for the treatment of progressive familial intrahepatic cholestasis (PFIC), and in the U.S. and E.U. for PFIC, and in the U.S. for ALGS. In the same month, final results from the CABINET Phase III trial were presented at the 2024 European Society for Medical Oncology Congress and were published in the New England Journal of Medicine, reinforcing the efficacy benefits of Cabometyx in advanced neuroendocrine tumors. It was announced at that time that Ipsen had submitted an extension of indication Marketing Authorization to the European Medicines Agency. Business development In August 2024, Ipsen entered into an agreement to sell its rare pediatric disease Priority Review Voucher. As part of the agreement, Ipsen received a cash payment of $158m in the third quarter. In October 2024, Eton Pharmaceuticals entered into an agreement with Ipsen to acquire Increlex® (mecasermin injection). The transaction is expected to close before the end of 2024. Arbitration proceedings with Galderma As of 30 September 2024, two arbitration proceedings initiated by Galderma against Ipsen at the International Chamber of Commerce (ICC) were ongoing. The first dispute, initiated by Galderma in 2021, pertains to the territorial scope of the commercial partnership related to Azzalure® (abobotulinumtoxinA) and Dysport under an agreement signed in 2007 in the E.U., in certain Eastern European countries, and in Central Asia. The Tribunal of the ICC Internal Court of Arbitration issued a final award, in October 2024, dismissing most, if not all, of Galderma's claims in this first arbitration and ordered that Galderma bear the majority of the legal fees and arbitration costs incurred by Ipsen. A second dispute was initiated by Galderma in November 2023, related to the validity of Ipsen’s 2023 termination of a joint R&D collaboration agreement entered into in 2014 under the parties’ respective early-stage neurotoxin programs, including the development of IPN10200. At this stage, Ipsen cannot reasonably predict any potential financial impact from this final remaining arbitration process, for which it intends to fully defend and vindicate its rights. Conference call A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its full-year and fourth-quarter results on 13 February 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2024 (YTD 2024) and the three-month period to 30 September 2024 (Q3 2024), compared to the nine-month period to 30 September 2023 (YTD 2023) and the three-month period to 30 September 2023 (Q3 2023), respectively. Commentary is based on the performance in YTD 2024, unless stated otherwise. About Ipsen Ipsen is a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fuelled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Craig Marks +44 (0)7584 349 193 Nicolas Bogler +33 6 52 19 98 92 Media Jennifer Smith-Parker +44 (0) 7843 137 764Anne Liontas +33 7 67 34 72 96 1 At constant exchange rates (CER), which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 Second-line primary biliary cholangitis.3 First-line metastatic pancreatic ductal adenocarcinoma. Attachment Ipsen - YTD 2024 sales announcement

Drug ApprovalPhase 3Clinical ResultLicense out/in

22 Oct 2024

·www.camurus.com

Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly

Lund, Sweden — 22 October 2024 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. The CRL is attributed to facility-related deficiencies identified during a Current Good Manufacturing Practices (cGMP) inspection of a third-party manufacturer completed in September 2024. FDA has communicated that its determination of responses from the facility as satisfactory is needed for a timely resolution of the CRL and approval of the NDA. The CRL did not state any other concerns, including related to clinical efficacy or safety of CAM2029. “The CRL is disappointing, however, we are confident in the data supporting our NDA and the potential of CAM2029 to address unmet medical needs of patients with acromegaly”, says Fredrik Tiberg, Camurus’ President & CEO. “Camurus is committed to working with the FDA and the third-party manufacturer to bring CAM2029 to patients living with acromegaly as soon as possible.” Labelling discussions with the FDA were held during the final stage of the NDA review and the prescribing information for CAM2029 is well advanced. In parallel with the US NDA process, a Market Authorization Application for CAM2029 for the treatment of acromegaly is under review in the EU. In addition, two development programs for CAM2029 for treatment of gastroenteropancreatic neuroendocrine tumors and polycystic liver disease are progressing. The CRL does not impact on the advancement of these programs. For more information Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 fredrik.tiberg@camurus.com Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 ir@camurus.com About acromegaly Acromegaly is a rare, slowly progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.1 Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.2,3 The prevalence of acromegaly is estimated to about 60 cases per million.4 About CAM2029 Octreotide SC depot, CAM2029, is an investigational, ready-to-use octreotide for subcutaneous administration under development for the treatment of acromegaly, as well as gastroentero-pancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). CAM2029 is designed for enhanced octreotide exposure and convenient, once-monthly administration with a prefilled pen to facilitate easy self-administration by patients. The CAM2029 clinical program for acromegaly comprises of seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.5 In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to SoC at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 was consistent with SoC with no new findings.6,7 CAM2029 has received orphan drug designation for acromegaly (EU) and for polycystic liver disease (EU and US). About Camurus Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of dependence, pain, cancer and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com. References Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111. Fleseriu M, et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63. Prescribing Information SANDOSTATIN® LAR, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf Ferone, D., et al. Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. J Clin Endocrinol Metab. Published 8 October, 2024. https://doi.org/10.1210/clinem/dgae707 Press release 15 July, 2024: https://www.camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients/ This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 1:00 am CET on 22 October 2024.

Clinical ResultPhase 3Orphan DrugNDAPhase 2

20 Sep 2024

·www.camurus.com

EMA positive opinion for orphan drug designation to Camurus’ octreotide SC depot for the treatment of polycystic liver disease

Lund, Sweden — 20 September 2024 — Camurus (NASDAQ STO: CAMX) today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has adopted a positive opinion for orphan drug designation (ODD) to the company’s investigational medicinal product, octreotide subcutaneous (SC) depot (CAM2029), for the treatment of autosomal dominant polycystic liver disease (PLD). The European Commission is now assessing the opinion and is expected to grant the designation within 30 days. PLD is a rare, genetic, and chronic disorder characterized by progressive growth of cysts in the liver, which can cause severe symptoms and result in impaired quality of life for patients. An estimated 37,000 patients in the US and EU are today living with PLD, of which a majority are women.1 “The positive opinion by the EMA underpins the need of a treatment for patients living with polycystic liver disease, for which there today is no approved pharmaceutical treatment in the EU”, says Dr Fredrik Tiberg, President & CEO of Camurus. “CAM2029 is currently being assessed for efficacy and safety in the POSITANO clinical study in patients with symptomatic PLD, with topline results expected in the first half of 2025.” CAM2029 has previously been granted ODD for the treatment of autosomal dominant PLD by the US Food and Drug Administration (FDA)2 and ODD for the treatment of acromegaly in the EU. For more information about EMA’s ODD program, visit: https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation-research-development For more information Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 fredrik.tiberg@camurus.com Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 ir@camurus.com About PLD Polycystic liver disease (PLD) is a rare genetic and chronic disorder characterized by progressive growth of fluid-filled cysts in the liver, which can cause severe symptoms such as abdominal pain and discomfort, shortness of breath (dyspnea), indigestion (dyspepsia), gastro-esophageal reflux, and limited mobility. Rare complications are hepatic cyst hemorrhage and infection or rupture.3-6 Age and gender contribute to disease severity; increasing age is positively associated with both cyst sizes and numbers, and women are highly overrepresented among symptomatic patients.7-9 Most patients with PLD are diagnosed in their 30s after reporting a sudden and accelerated increase of abdominal breadth together with PLD-related symptoms.8 There is currently no approved pharmacological treatment for PLD. Clinical studies indicate that somatostatin receptor ligands, e.g., octreotide, can slow down cyst growth, decrease fluid secretion, and reduce the liver volume.10-12 About octreotide SC depot (CAM2029) CAM2029 is a ready-to-use, long-acting subcutaneous depot of octreotide under development for treatment of three rare disease indications: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). CAM2029 has been evaluated in a comprehensive clinical program, including five Phase 1 and 2 studies, two Phase 3 studies in acromegaly (ACROINNOVA 1 and 2), an ongoing Phase 3 study in patients with GEP-NET (SORENTO), and an ongoing Phase 2/3 study in patients with PLD (POSITANO). CAM2029 is designed for enhanced octreotide exposure and convenient, once-monthly administration with a prefilled autoinjector pen to facilitate easy self-administration by patients. About the POSITANO study POSITANO is a randomized, double-blind, placebo-controlled Phase 2/3 study evaluating efficacy and safety of CAM2029 in patients with symptomatic PLD. Primary endpoint is change in height-adjusted total liver volume (htTLV) and first secondary endpoint is change in self-reported disease symptoms. For more information, visit www.clinicaltrials.gov (NCT05281328). About Camurus Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of dependence, pain, cancer and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com. References Est. in US and EU4+UK. Globe Life Sciences report 2020; data on file. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=836621 bu-Wasel, B., et al. Pathophysiology, epidemiology, classification and treatment options for polycystic liver diseases. World J Gastroenterol. 2013. 19(35): p. 5775-86. Perugorria, M.J., et al. Polycystic liver diseases: advanced insights into the molecular mechanisms. Nat Rev Gastroenterol Hepatol. 2014. 11(12): p. 750-61. Neijenhuis, M.K., et al. Impact of liver volume on polycystic liver disease-related symptoms and quality of life. United European Gastroenterol J. 2018. 6(1): p. 81-88. Olaizola P., et al. Genetics, pathobiology and therapeutic opportunities of polycystic liver disease. Nat Rev Gastroenterol Hepatol. 2022 May 13. van Keimpema L., et al. Patients with isolated polycystic liver disease referred to liver centres: clinical characterization of 137 cases. Liver international. 2011;31(1):92-8. van Aerts RMM, et al. Clinical management of polycystic liver disease. J Hepatol. 2018;68(4):827-37.50. van Aerts RMM, et al. Severity in polycystic liver disease is associated with aetiology and female gender: Results of the International PLD Registry. Liver international. 2019;39(3):575-82. Gevers T. J. G., et al. Effect of lanreotide on polycystic liver and kidneys in autosomal dominant polycystic kidney disease: an observational trial. Liver International. 2015 May;35(5):1607-14. Pisani A., et al. Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease. Clin Gastroenterol Hepatol. 2016 Jul;14(7):1022-1030. van Aerts RMM, et al., Lanreotide Reduces Liver Growth In Patients With Autosomal Dominant Polycystic Liver and Kidney Disease. Gastroenterology. 2019 Aug;157(2):481-491. This information was submitted for publication at 8:00 am CET on 20 September 2024.

Orphan DrugPhase 1Oligonucleotide

100 Deals associated with Lanreotide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D04666	Lanreotide Acetate	H01CB03	DB06791

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pituitary Neoplasms	JP	Teijin Ltd.	15 Jan 2021
Gigantism	JP	Teijin Ltd.	08 Jan 2013
Gastro-Enteropancreatic Neuroendocrine Tumor	AU	Ipsen Pty Ltd.	11 Sep 2003
Carcinoid Tumor	KR	Ipsen Ltd.	08 Aug 2002
Neuroendocrine Tumors	KR	Ipsen Ltd.	08 Aug 2002
Acromegaly	CN	Ipsen Pharma Biotech SAS	14 Mar 2002
Malignant Carcinoid Syndrome	CN	Ipsen Pharma Biotech SAS	14 Mar 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neuroendocrine neoplasm of lung	Phase 3	US	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	AT	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	CA	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	DK	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	FR	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	DE	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	IT	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	NL	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	PL	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	ES	Ipsen SA	06 Mar 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04852679 (PALACE, CTgov)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	43	Lanreotide autogel	gaowlxsyez(mdbvmzymjk) = psqiaywosk ppmiddwxxa (uqjlwrsxzi, iavzujdnvm - rmfmohwvxb) View more	-	01 Oct 2024
NCT02859064 (CTgov)	Phase 2	Carcinoid Tumor \| Gastro-Enteropancreatic Neuroendocrine Tumor	6	Y-90 microspheres+Lanreotide	tnftrwxtzl(hqrfgennrv) = akxeqwyaba xwbtwiehse (xpbmtgsbtm, woeziudfnj - ahorjuqjhr) View more	-	27 Jul 2023
NCT03043664 (PLANET, CTgov)	Phase 1/2	Gastro-Enteropancreatic Neuroendocrine Tumor	22	Keytruda (pembrolizumab)	ilcgxklbfz(pnqybsdfgw) = zodmiwjyvf vgwnwwnqaq (anvfhtbsud, pmxsbnvbix - jsvwylqubi) View more	-	28 Sep 2022
NCT02288377 (Prodige 31 REMINET, Pubmed)	Phase 2	Neuroendocrine Tumors Maintenance \| First line	53	Lanreotide autogel 120 mg	(kehabauwdk) = vdsguyhemv daekdaobdq (ljyhvtghad )	Positive	07 Sep 2022
NCT02288377 (Prodige 31 REMINET, Pubmed)	Phase 2	Neuroendocrine Tumors Maintenance \| First line	53	Placebo	(kehabauwdk) = hgsmrsvysc daekdaobdq (ljyhvtghad )	Positive	07 Sep 2022
NCT02698410 (ATLANT, Pubmed)	Phase 2	Neuroendocrine Tumors	40	Lanreotide autogel 120 mg	ivzlqhnlsp(cujoxuforv) = plxqmicppw lhvdomdccb (swxuubipaj, 20.63 - 51.68) View more	-	31 Aug 2022
NCT02275338 (Pubmed \| Clin Ther)	Phase 2	Malignant Bowel Obstruction	52	Lanreotide Autogel 120 mg	edrjmqemex(hlnwfjtcyw) = adfhsmjnpf bhmozbeble (wxlkglvhnn )	-	01 Dec 2021
NCT02288377 (REMINET \| Prodige 31 REMINET, CTgov)	Phase 2/3	Neuroendocrine Tumors	53	Placebo (Placebo)	syndybtamn(echqwaiywk) = xxnfrtksqt irvqnnngfm (crjnimkvos, xpzpxmfehm - umnjnsyyrl) View more	-	04 Oct 2021
NCT02288377 (REMINET \| Prodige 31 REMINET, CTgov)	Phase 2/3	Neuroendocrine Tumors	53	lanreotide (Lanreotide)	syndybtamn(echqwaiywk) = socezprocu irvqnnngfm (crjnimkvos, dcqgtvjgwk - annkkkdtwp) View more	-	04 Oct 2021
EUCTR2015-004992-62-DE \| NCT02683941 (SPINET, ESMO2021) Manual	Phase 3	Neuroendocrine Tumors SSTR Positive	77	Lanreotide autogel/depot	fgqelbwsmw(rldtzoyojj) = ldlvqkxapx deidxrwtas (znjfjzsjwk, 11.3–21.9) View more	Positive	21 Sep 2021
	Phase 3	Neuroendocrine Tumors SSTR Positive	77	Lanreotide autogel/depot (OL-LAN)	ibelsmhznw(mcwbiiyqzg) = yxdyngfqbm dfwbbxxxco (fqlhhnsedz ) View more	Positive	21 Sep 2021
NCT03043664 (PLANET, ASCO_GI2021) Manual	Phase 1/2	Gastro-Enteropancreatic Neuroendocrine Tumor	22	pembrolizumab+lanreotide	qkbpszbrkd(hqvyntqpsa) = rzdzdcejax cvufcyabdl (dudcakvvyg, 1.7 - 8.3) View more	Negative	22 Jan 2021

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