The myeloprotective effect of the CDK4/6 inhibitor, trilaciclib, in patients with locally advanced nasopharyngeal carcinoma receiving induction chemotherapy: a phase II clinical trial

Start Date18 Aug 2024

Sponsor / Collaborator

The First Hospital Of China Medical University

ChiCTR2400087694 / RecruitingPhase 4IIT

A Single-Arm, Observational Study to Assess the Efficacy and Safety of Trilaciclib in Extensive Stage Small Cell Lung Cancer Patients with Chemotherapy Induced Grade 3/4 Myelosuppression Following Prior Chemotherapy

Start Date01 Aug 2024

Sponsor / Collaborator-

NCT06569459 / RecruitingPhase 2IIT

A Prospective, Randomized, Controlled, Single-center Phase II Clinical Trial of Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy for Locally Advanced Esophageal Cancer.

This study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.

Start Date09 Jul 2024

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

100 Clinical Results associated with Trilaciclib Dihydrochloride

100 Translational Medicine associated with Trilaciclib Dihydrochloride

100 Patents (Medical) associated with Trilaciclib Dihydrochloride

Literatures (Medical) associated with Trilaciclib Dihydrochloride

01 Sep 2024·SUPPORTIVE CARE IN CANCER

Trilaciclib use in extensive-stage small cell lung cancer (ES-SCLC): are clinical benefits seen in the real-world setting?

Article

Author: Attwood, Kristopher ; Billias, Christina ; Baron, Jeffrey ; Dy, Grace K. ; Dy, Grace K ; Holdsworth, Allison ; Przespolewski, Eugene ; Elijah, Joseph ; Wang, Katy ; Jain, Prantesh

Abstract:

Background:

Trilaciclib, in comparison to placebo plus carboplatin, etoposide, ± atezolizumab (PEA), has shown significant reductions in incidence of severe neutropenia (SN) among patients with extensive-stage small cell lung cancer (ES-SCLC). Despite these findings, real-world utility remains limited.

Methods:

A single-center quasi-experimental study compared trilaciclib + PEA (PEAT) versus PEA in ES-SCLC patients. The study period ranged from April 1, 2021 to July 31, 2022, for the PEAT recipients and February 1, 2020, to February 28, 2021, for PEA recipients. The primary endpoint evaluated was incidence of SN after cycle 1 and during the treatment period. Secondary endpoints included measures related to myelopreservation and patient outcomes.

Results:

Among 34 PEAT and 44 PEA patients, baseline characteristics were similar, except for a higher median age (69 vs 64 years) and more males (64.7% vs 38.6%) in the PEAT cohort. The PEAT cohort exhibited a lower SN rate (3%) versus the PEA cohort (18%), with statistical significance demonstrated on multivariate analysis (p = 0.015). Additionally, the PEAT cohort also demonstrated significant reductions in red blood cell transfusion requirements (3% vs 23%; p = 0.02), grade 3–4 anemia (6% vs 25%; p = 0.03), and grade 3–4 thrombocytopenia (0% vs 11%, p = 0.045).

Conclusion:

Trilaciclib, in combination with PEA, demonstrated an improvement in the safety profile without compromising survival outcomes in ES-SCLC patients. These findings underscore the potential benefits of incorporating trilaciclib in real-world clinical settings for enhanced patient care.

01 Aug 2024·Journal of clinical pharmacology

Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics

Article

Author: Preston, Richard A ; Li, Chao ; Beelen, Andrew ; Marbury, Thomas C ; Dumas, Emily

Abstract:

Trilaciclib is a first‐in‐class, intravenous cyclin‐dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy‐induced myelosuppression in adult patients with extensive‐stage small cell lung cancer receiving a platinum/etoposide‐containing or topotecan‐containing regimen. No dose adjustment is recommended for participants with mild hepatic impairment (HI) based on previous population pharmacokinetic (PK) analysis. This open‐label, parallel‐group study examined the impact of moderate and severe HI on the PK of trilaciclib. The study employed a reduced study design. Participants with moderate (Child–Pugh B, n = 8) and severe (Child–Pugh C, n = 5) HI and matched healthy controls (n = 11) received a single intravenous dose of trilaciclib 100 mg/m2. The unbound fraction of trilaciclib was comparable between the HI groups and the matched healthy control group. The unbound trilaciclib extent of exposure (i.e., area under the concentration‐time curve) in participants with moderate and severe HI was ∼40% and ∼60% higher, respectively, compared with healthy matched controls based on Child–Pugh classification. Ad hoc analysis using National Cancer Institute classification showed similar results. The US Food and Drug Administration‐approved trilaciclib dose of 240 mg/m2 should be reduced by ∼30%, to 170 mg/m2, for patients with moderate or severe HI.

01 Aug 2024·BIOORGANIC CHEMISTRY

Unveiling the promise of pyrimidine-modified CDK inhibitors in cancer treatment

Review

Author: Sharma, Anushka ; Dubey, Rahul ; Asati, Vivek ; Sahu, Adarsh ; Makhija, Rahul

Cyclin-dependent kinases (CDKs) constitute a vital family of protein-serine kinases, pivotal in regulating various cellular processes such as the cell cycle, metabolism, proteolysis, and neural functions. Dysregulation or overexpression of CDK kinases is directly linked to the development of cancer. However, the currently approved CDK inhibitors by the US FDA, such as palbociclib, ribociclib, Trilaciclib, Abemaciclib, etc., although effective, exhibit limited specificity and often lead to undesirable adverse effects. First and second-generation CDK inhibitors have not gained significant clinical interaction due to their high toxicity and lack of specificity. To address these challenges, a combined approach is being employed in the quest for newer CDK inhibitors aimed at mitigating toxicity and side effects associated with CDKIs. The discovery of therapeutic agents selectively targeting tumorous cells, such as CDK inhibitors, has demonstrated promise in treating various cancers, including breast cancer. Extensive literature reviews have facilitated the development of novel CDK inhibitors by combining medicinally preferred pyrimidine derivatives with other heterocyclic rings. Pyrimidine derivatives substituted with pyrazole, imidazole, benzamide, benzene sulfonamide, indole carbohydrazide, and other privileged heterocyclic rings have shown encouraging efficacy in inhibiting cyclin-dependent kinase activity. This review provides comprehensive data, including structure-activity relationship (SAR), anticancer activity, and kinetics studies of potent compounds. Additionally, molecular docking studies with compounds under clinical trial and patents filed on pyrimidine based CDK inhibitors in cancer treatment are included. This review serves as a valuable resource for further development of CDK kinase inhibitors for cancer treatment, offering insights into their efficacy, specificity, and potential clinical applications.

145

News (Medical) associated with Trilaciclib Dihydrochloride

20 Sep 2024

·www.prnewswire.com

Global Cancer Rates Surge as Biotech Innovators Work on New Therapies

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 20, 2024 /PRNewswire/ -- USA News Group – Cancer rates are rising globally, and the outlook is particularly concerning for men. A recent global study projects an 84% increase in cancer cases and a 93% rise in cancer deaths among men by 2050. According to Our World in Data, cancer has overtaken cardiovascular diseases as the leading cause of death in several wealthy nations. Despite warnings from the American Cancer Society, which found that 44% of cancer deaths in U.S. adults are linked to lifestyle factors, troubling trends continue. Another study revealed that even light drinking is associated with an increase in cancer deaths among older adults in Britain. Meanwhile, behind the scenes, biotech innovators are developing new targets for improved cancer therapies, driving the next wave of breakthroughs in oncology coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), G1 Therapeutics, Inc. (NASDAQ: GTHX), Arcellx, Inc. (NASDQ: ACLX), Sanofi (NASDAQ: SNY), and Halozyme Therapeutics, Inc. (NASDAQ: HALO) . Building upon seemingly strong results from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to make impressive strides toward a pivotal registration-enabling study for its flagship cancer therapy, pelareorep. The BRACELET-1 Phase 2 trial delivered highly encouraging data, reinforcing the potential for pelareorep-based therapies to bring meaningful benefits to patients with HR+/HER2- advanced or metastatic breast cancer. One of the most intriguing results is the median overall survival (OS) in the pelareorep arm, which has not yet been reached—indicating that more than half of the patients were still alive at the end of the study. For comparison, the median OS in the paclitaxel-only control group was 18.2 months. This translates into a two-year survival rate of 64% for patients receiving pelareorep + paclitaxel, nearly double the 33% rate observed in patients treated with paclitaxel alone. The progression-free survival (PFS) results were equally impressive, showing a median of 12.1 months for the combination therapy, compared to 6.4 months for paclitaxel monotherapy. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These results are more than just numbers—they underscore the potential of pelareorep to significantly extend survival times for breast cancer patients, offering renewed hope to those battling this aggressive form of cancer. The positive results from BRACELET-1 mirror those of the earlier IND-213 trial, which led to FDA Fast Track Designation for pelareorep back in 2017, further cementing its status as a therapy with game-changing potential. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." With such compelling data in hand, Oncolytics is now preparing for the next major milestone: securing funding for a registration-enabling study. This critical step will bring pelareorep closer to becoming an approved treatment option for breast cancer patients, offering a new lifeline in the fight against cancer. Set to be acquired by leading iron deficiency anemia treatment developer Pharmacosmos, commercial-stage oncology company G1 Therapeutics, Inc. (NASDAQ: GTHX) put out its Q2 2024 and operational highlights which included mention of its positive efficacy results from its Phase 2 trial of Trilaciclib in combination with a TROP2 ADC that were presented at the 2024 ASCO annual meeting, as well as final analysis of the Phase 3 PRESERVE 2 trial in 1L metastatic triple negative breast cancer (mTNBC) which showed continued evidence of myeloprotection, but didn't achieve its primary OS endpoint. "We are excited about what will be possible by the combined Pharmacosmos + G1 team as we meet the needs of more cancer patients," said Jack Bailey, CEO of G1 Therapeutics. "This transaction delivers a significant premium to our shareholders and better and broader access to COSELA for the cancer patients we seek to treat. In the meantime, as we move toward closing, our focus remains on accelerating and expanding the growth of the COSELA business in extensive stage small cell lung cancer; the double-digit quarter-over-quarter growth we experienced in vial volume and net revenue represents continued progress in that regard." Reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, Arcellx, Inc. (NASDQ: ACLX) recently put out its Q2 2024 financial results and business updates, which included mention of earning a $68 million milestone payment from Kite, a Gilead company, which Arcellx continues to have momentum with in advancements in anito-cel multiple myeloma. "We continue to make significant strides as we accelerate our business," said Rami Elghandour, Chairman and CEO of Arcellx. "We are thrilled about the momentum across our multiple myeloma program being developed in partnership with Kite. We believe anito-cel has the potential to be a best-in-class treatment option, and with the strength of our Kite partnership, we are well-positioned to change the treatment paradigm for multiple myeloma patients. We look forward to presenting data from the iMMagine-1 study by the end of this year. As iMMagine-1 continues to mature, we're also pleased with the progress in iMMagine-3, which was initiated by our partner Kite. More broadly, we believe that our novel synthetic binder, the D-Domain, which forms the basis of our technology platform and our lead program anito-cel, can be developed in oncology and non-oncology indications." Another joint oncology effort is coming from Sanofi (NASDAQ: SNY) through an exclusive licensing agreement with RadioMedix, and Orano Med to develop lead-212 (212Pb) radioligand therapies (RLTs) against cancer. The specifically focuses on the late-stage project, AlphaMedixTM (212Pb-DOTAMTATE), which currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedixTM is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. "We are excited to develop a leading-edge project in the rapidly evolving field of radioligand therapies in rare cancers," said Dietmar Berger, Chief Medical Officer, Global Head of Development, of Sanofi. "Early results for 212Pb have demonstrated its differentiated biophysical and clinical profile, reinforcing its potential to be a transformative radioligand therapeutic for patients across multiple difficult-to-treat rare cancers. This agreement underscores our efforts to explore innovative collaborations that leverage novel technologies to address the needs of people living with cancer." Halozyme Therapeutics, Inc. (NASDAQ: HALO) is celebrating the FDA approval of Roche's Tecentriq Hybreza™ with its drug delivery technology ENHANZE® for multiple types of cancer. Tecentriq Hybreza™ offers a faster administration option, with a subcutaneous injection that takes about 7 minutes, compared to the 30-60 minutes required for the standard intravenous (IV) infusion of Tecentriq® (atezolizumab). This new treatment will be available in the U.S. for all approved adult uses of the IV version, including certain types of lung, liver, skin, and soft tissue cancers. "We are delighted that Tecentriq Hybreza has been approved in the U.S. for all approved adult indications of the IV treatment," said Dr. Helen Torley, president and CEO of Halozyme. "This approval represents another opportunity for our ENHANZE technology to provide patients and physicians with greater flexibility and a new option for how treatment is administered." The FDA's approval was based on pivotal data from Roche's Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2License out/in

19 Sep 2024

·www.pharmaceutical-technology.com

Lupin and Takeda to commercialise Vonoprazan in India

The agreement will allow Lupin to expand its gastroenterology portfolio in the Indian market. Credit: Orawan Pattarawimonchai/Shutterstock. Pharmaceutical company Lupin has announced a non-exclusive patent licence agreement with Takeda Pharmaceutical for the commercialisation of Vonoprazan tablets in India. The medication will be sold under the brand name Lupin’s Lupivon in the Indian market. Vonoprazan will be made available in 10mg and 20mg strengths. A potassium-competitive acid blocker (P-CAB), the drug differs from traditional acid suppressants such as proton pump inhibitors by offering rapid and complete proton pump inhibition from the first dose. Its longer duration of action also ensures effective control of nocturnal acid breakthrough, and it can be dosed independently of meals. See Also: Trilaciclib by G1 Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval SX-682 by Syntrix Pharmaceuticals for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval The Drug Controller General of India (DCGI) has approved Vonoprazan for the treatment of gastric ulcers, reflux esophagitis and duodenal ulcers, and as part of the Helicobacter pylori eradication regimen. The agreement will allow Lupin to expand its gastroenterology portfolio in the Indian market, where acid peptic disorders (APD) are claimed to be highly prevalent. APDs encompassing gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD), impact a significant portion of the Indian population. GERD prevalence varies from 5% to 28.5%, while PUD affects approximately 8%. Older age, higher body mass index, non-vegetarian diets, consumption of tea or coffee and lifestyle choices such as smoking and alcohol intake are the risk factors for GERD. Lupin India Region Formulations president Rajeev Sibal stated: “We are very pleased to commercialise Vonoprazan, a novel treatment option for acid peptic disorders. “This is a further step in strengthening our gastroenterology portfolio and is in line with our commitment to introduce innovative medicines to address the unmet needs of our patients.” In November 2023, Lupin introduced the fixed-dose triple combination (FDC) drug , Vilfuro-G, to manage chronic obstructive pulmonary disease in India.

License out/inDrug Approval

18 Sep 2024

·www.globenewswire.com

Pharmacosmos Group and G1 Therapeutics Announce Successful Closing of Tender Offer

- Transaction Will Maximize the Access and Uptake of COSELA® (trilaciclib), the First and Only Proactive Multilineage Myeloprotection Agent - - G1 Stockholders to Receive U.S. $7.15 Per Share in Cash - HOLBAEK, Denmark and RESEARCH TRIANGLE PARK, N.C., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Pharmacosmos A/S, a leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anemia, and G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company focused on delivering next-generation therapies that improve the lives of those affected by cancer, today announced that Pharmacosmos A/S has successfully completed the previously announced tender offer to acquire all outstanding shares of G1 Therapeutics for U.S. $7.15 per share net to the holder in cash, without interest and less any applicable withholding taxes (the “Offer Price”), for a total equity value of approximately $405 million. “We are excited to announce the completion of Pharmacosmos’ acquisition of G1. This acquisition fits perfectly with our strategy and positions our company for the next phase of growth. We are particularly thrilled to expand our product portfolio with Cosela, an innovative first-in-class product that is making a real difference for patients with small cell lung cancer. Our focus will now be on bringing Cosela to more patients and customers in the US, where it is already approved, and to start the work to have it registered and made available internationally including in the UK and EU,” said Tobias S Christensen - CEO and President of Pharmacosmos A/S. The tender offer commenced on August 20, 2024 and expired one minute after 11:59 p.m. Eastern Time on September 17, 2024 (the "Expiration Date"). As of the Expiration Date, a total of 39,486,447 shares of G1 Therapeutics common stock were validly tendered, and not validly withdrawn, representing approximately 74.64% of the outstanding shares of G1 Therapeutics common stock as of the Expiration Date. As of the Expiration Date, the number of shares validly tendered in accordance with the terms of the tender offer and not validly withdrawn satisfied the minimum tender condition, and all other conditions to the tender offer were satisfied. On September 18, 2024, Genesis Merger Sub, Inc., an indirect wholly owned subsidiary of Pharmacosmos A/S (“Purchaser”), irrevocably accepted for payment all shares validly tendered and not validly withdrawn and has paid the depositary for such shares. Following the closing of the tender offer, on September 18, 2024 Purchaser merged with and into G1 Therapeutics, with G1 Therapeutics continuing as the surviving corporation and a wholly owned subsidiary of Pharmacosmos Therapeutics Inc., a U.S. subsidiary of Pharmacosmos A/S. In connection with the merger, all shares of G1 Therapeutics common stock (other than (i) shares of common stock held in the treasury of G1 Therapeutics, (ii) shares of common stock owned by Pharmacosmos A/S, Purchaser, G1 Therapeutics or any of their respective direct or indirect wholly owned subsidiaries, and (iii) shares of common stock held by stockholders who have properly demanded appraisal of such shares in accordance with Delaware law) that had not been validly tendered were converted into the right to receive an amount in cash equal to the Offer Price. As a result of the transaction, G1 Therapeutics shares ceased to be traded on NASDAQ as of the date of closing of the acquisition, and shares of G1 Therapeutics common stock will be delisted from NASDAQ and deregistered under the Securities Exchange Act of 1934, as amended. “Since our founding in 2008, G1 has been committed to improving the lives of patients living with cancer; this effort culminated in the approval and launch of COSELA® (trilaciclib), the first and only therapy that proactively delivers multilineage myeloprotection to patients with extensive-stage small cell lung cancer being treated with chemotherapy,” said Jack Bailey, Chief Executive Officer at G1 Therapeutics. “The closing of this transaction is an exciting moment for everyone working in G1 and Pharmcosmos, and the patients we seek to treat, as the combined team moves forward with COSELA to meet the needs of even more cancer patients. Finally, I want to thank the members of the G1 team throughout these last 16 years that made this innovation possible.” Advisors For Pharmacosmos, MTS Health Partners, L.P. served as exclusive financial advisor, and Arnold & Porter Kaye Scholer LLP served as legal counsel. For G1 Therapeutics, Centerview Partners LLC served as exclusive financial advisor, and Ropes & Gray LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel. Indication COSELA® (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. Important Safety Information COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity. The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/ To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Pharmacosmos Group Pharmacosmos A/S, headquartered in Holbaek, Denmark, and founded in 1965, is a highly specialised company focused on carbohydrate chemistry and a global leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anaemia. With companies in the UK, Ireland, Nordics, Germany, the USA, and China, as well as through partners, Pharmacosmos markets its products around the world. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with deep expertise in the synthesis of iron-carbohydrate complexes. The Pharmacosmos Group has more than 500 employees. About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage oncology biopharmaceutical company whose mission is to develop and deliver next-generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1’s goal is to provide innovative therapeutic advances for people living with cancer. G1 is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. Pharmacosmos A/S Contact: Christian Lundquist MadsenVP Global Marketing & Communication+45 5948 5959 clm@pharmacosmos.com G1 Therapeutics Contacts: Will RobertsCommunications OfficerVice President, Investor Relations and Corporate Communications(919) 907-1944 wroberts@g1therapeutics.com

Acquisition

100 Deals associated with Trilaciclib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11987	Trilaciclib Dihydrochloride	L01XE	DB15442

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
ES-SCLC	CN	G1 Therapeutics, Inc.	12 Jul 2022
Chemotherapy-induced myelosuppression	US	G1 Therapeutics, Inc.	12 Feb 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Small Cell Lung Cancer	NDA/BLA	CN	Simcere Pharmaceutical Group Ltd.	01 Jun 2023
Triple Negative Breast Cancer	Phase 3	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	07 Dec 2021
Triple Negative Breast Cancer	Phase 3	CN	G1 Therapeutics, Inc.	07 Dec 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	US	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	CN	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	AU	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	BG	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	FR	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	GE	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	MD	G1 Therapeutics, Inc.	14 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06332287 (ESMO2024) Manual	Phase 2	Metastatic Malignant Neoplasm to the Leptomeninges \| Non-Small Cell Lung Cancer Consolidation	28	Trilaciclib + Pemetrexed	owxcorlych(qofermymre) = None of the 28 patients developed SN or febrile neutropenia (FN) in the first cycle. During treatment, only 1 patient (4%) developed grade 3/4 neutropenia, and no grade 3/4 anemia and ≥ grade 3 thrombocytopenia were observed. Most common adverse events were grade 1/2, and no treatment-related deaths occurred. vgmdwstnuy (wwmsgirvzj )	Positive	14 Sep 2024
WCLC2024 Manual	Not Applicable	ES-SCLC	94	Trilaciclib	oophaclals(jusppazuxo) = tzqpzriizh dorzwqahep (ouotzqnwrp ) View more	Positive	07 Sep 2024
				Control	oophaclals(jusppazuxo) = ynwjymhwna dorzwqahep (ouotzqnwrp ) View more
NCT04902885 (TRACES, CTgov)	Phase 3	ES-SCLC	95	etoposide+carboplatin+Trilaciclib+Topotecan (Part I ( Safety run-in and PK Evaluation); Trilaciclib Group)	vsvvtfrerf(ehuavlrhsm) = csvbeoxwnn fsvlbynszv (veqdgeejih, lhjreacdfv - ahgyvtsowi) View more	-	10 Jul 2024
				etoposide+carboplatin+Trilaciclib+Topotecan (Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group)	vsvvtfrerf(ehuavlrhsm) = hroakrrvrt fsvlbynszv (veqdgeejih, tvhvngbcng - tcohgbkjuw) View more
NCT04799249 (PRESERVE 2, Company_Website) Manual	Phase 3	Metastatic Triple-Negative Breast Carcinoma First line	187	Trilaciclib plus gemcitabine and carboplatin	vwksrogzkn(dtuekskxeq) = jbegxshwsq sbyktjrftg (aupveuikar ) Not Met	Negative	24 Jun 2024
				Placebo+ gemcitabine and carboplatin	vwksrogzkn(dtuekskxeq) = huivgadghn sbyktjrftg (aupveuikar ) Not Met
NCT05113966 (ASCENT, ASCO2024) Manual	Phase 2	Triple Negative Breast Cancer human epidermal growth factor receptor 2-negative \| hormone receptor negative	30	Trilaciclib 240 mg/m2 + Sacituzumab govitecan 10 mg/kg	avodnphrjw(maenlonial) = bmvglxujcn hiokqbxqpc (jfqfdzkppo, 9.9 - 42.3) View more	Positive	24 May 2024
NCT05112536 (CTgov)	Phase 2	Triple Negative Breast Cancer	24	Cylophosphamide+Carboplatin (Investigator discretion)+Trilaciclib+doxorubicin+paclitaxel+Pembrolizumab (Investigator discretion)	ocjlsoypjb(efjqkrxoct) = fzjrbbmngm kgweghvtgc (dobvfvqycz, wisxgdlbmn - oadtoojxkf) View more	-	12 Mar 2024
G1T28-04 (NEWS) Manual	Phase 2	Triple Negative Breast Cancer ER Negative \| PR Negative \| HER2 Negative	102	曲拉西利和GCb (接受何种SACT)	zdtiyeyzha(ndzchsxiwh) = fnsycugiuu uemsgocywk (xvhhkfjrkg ) View more	Positive	12 Dec 2023
				GCb (接受何种SACT)	zdtiyeyzha(ndzchsxiwh) = aqtlwadbug uemsgocywk (xvhhkfjrkg ) View more
NCT02978716 (SABCS2023)	Phase 2	Metastatic Triple-Negative Breast Carcinoma	-	Trilaciclib + GCb	agtvhsmlxl(frjdccaqqk) = tkrakrnoop leymcwoqgd (bxgcfbhocy )	Positive	05 Dec 2023
				GCb alone	agtvhsmlxl(frjdccaqqk) = axcapugsko leymcwoqgd (bxgcfbhocy )
NCT02978716 (GlobeNewswire) Manual	Phase 2	Metastatic Triple-Negative Breast Carcinoma PR Negative \| HER2 Negative \| ER Negative	63	trilaciclib+gemcitabine + carboplatin (received SACT)	gmfepepwew(vimgoftnuq) = igcxrbogla wtzrusaoeq (fvejxjkncc ) View more	Positive	29 Nov 2023
				gemcitabine+carboplatin (received SACT)	gmfepepwew(vimgoftnuq) = uwcdiyfbck wtzrusaoeq (fvejxjkncc ) View more
TRACES (ESMO2023) Manual	Phase 3	ES-SCLC	83	Trilaciclib	zggavgmpcc(qzmnpbhtkq) = hvdsxznhfx kmjujldrae (pwduaipzep ) View more	Positive	21 Oct 2023
				Placebo	zggavgmpcc(qzmnpbhtkq) = paeksskhjd kmjujldrae (pwduaipzep ) View more

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