Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Start Date13 Sep 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT06417775

/ RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date10 Sep 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06212661

/ Enrolling by invitationNot ApplicableIIT

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Start Date05 Apr 2024

Sponsor / Collaborator

The Cleveland Clinic Foundation

100 Clinical Results associated with Ubrogepant

100 Translational Medicine associated with Ubrogepant

100 Patents (Medical) associated with Ubrogepant

373

Literatures (Medical) associated with Ubrogepant

24 Mar 2025·Journal of biomolecular structure & dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Abdalla, Mohnad ; Mitra, Debanjan ; Afreen, Shagufta ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.Communicated by Ramaswamy H. Sarma.

01 Feb 2025·ADVANCES IN THERAPY

US Real-World Effectiveness, Tolerability, and Healthcare Resource Utilization After Addition of Fremanezumab for Preventive Treatment in Patients Using Gepants for Acute Treatment of Migraine: Results From a Retrospective Chart Review

Article

Author: Krasenbaum, Lynda J ; Carr, Karen ; Driessen, Maurice T ; Saikali, Nicolas P ; Eugeni, Patrick ; Niu, Zhongzheng ; McVige, Jennifer W ; Seminerio, Michael J ; Rooney, Megan E

INTRODUCTION:

Fremanezumab, a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway, and gepants, small molecule CGRP receptor antagonists, are both approved for the treatment of migraine or its symptoms. This study assessed effectiveness, tolerability, and migraine-related healthcare resource utilization (HCRU) after the addition of fremanezumab for preventive migraine treatment in patients using gepants for acute treatment.

METHODS:

Data were extracted during a retrospective chart review from electronic medical records from the Dent Neurologic Institute. Eligible patients were ≥ 18 years old, using gepants (rimegepant or ubrogepant), who initiated fremanezumab between January 1, 2020, and May 1, 2021 (index date: date of fremanezumab initiation) and continued concomitant use of gepants and fremanezumab for ≥ 1 month (post-index; between 7-9 months of follow-up). Outcomes included monthly migraine days (MMD), adverse events (AEs), reasons for discontinuation, and migraine-related HCRU.

RESULTS:

A total of 55 patients [female, 93%; mean (SD) age, 43.5 (13.5) years] met the inclusion criteria. All patients were diagnosed with chronic migraine. Patients had an average (SD) MMD of 15.8 (7.4) at the index date. Average (SE) change in MMD from index date to post-index was - 6.5 (1.0) days (p < 0.0001). Five patients (9.1%) experienced AEs post-index; no serious AEs (SAEs) were reported. The number of migraine-related medications used decreased from the index date to post-index by a mean of 0.6 for preventive medications (p = 0.070), and 0.8 for acute medications (p = 0.050). The number of outpatient office-based visits also decreased [mean (SD): 6 months pre-index, 5.8 (4.4) vs. 6 months post-index, 4.1 (4.0); p < 0.0001].

CONCLUSION:

The addition of fremanezumab preventively to gepants for acute migraine treatment was effective, resulted in fewer outpatient office visits, and yielded no SAEs or AEs that were novel to these migraine medication classes.

01 Dec 2024·CNS & Neurological Disorders-Drug Targets

Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis

Review

Author: Datusalia, Ashok Kumar ; Singh, Pooja ; Kumar, Anoop ; Ponnada, Rakesh Kumar ; Sharma, Ruchika ; Sumadhura, Bommaraju

Background::

Recently, US Food and Drug Administration (FDA) has approved calcitonin gene-related peptide receptor antagonists (rimegepant, and ubrogepant), and selective serotonin receptor agonists (lasmiditan) in the management of migraine. However, the exact safety and efficacy profile of these drugs is unclear so far.

Methods::

The study’s primary objective was to determine the exact safety and efficacy profile. The overall estimate was calculated in terms of risk ratios using a suitable model. The subgroup analysis was also performed to check the effect of individual drugs on the outcome, whereas sensitivity analysis was performed to check the effects of outliers on the outcome. All the analyses were performed using Rev Man 5. The drugs have shown significant improvement in efficacy parameters (pain freedom, most bothersome symptoms, phonophobia, nausea, and photophobia).

Results::

The subgroup analysis results have shown significant improvement in all efficacy parameters in the rimegepant and ubrogepant groups. The effect of ubrogepant on safety parameters was found to be non-significant, indicating a better safety profile of ubrogepant than lasmiditan.

Conclusion::

The sensitivity analysis results have shown no effect of outliers on the efficacy parameters. Based on the available evidence, recently approved drugs are effective in the treatment of migraine, however, associated with few adverse drug reactions.

News (Medical) associated with Ubrogepant

31 Jan 2025

·www.prnewswire.com

AbbVie Reports Full-Year and Fourth-Quarter 2024 Financial Results

Reports Full-Year Diluted EPS of $2.39 on a GAAP Basis, a Decrease of 12.1 Percent; Adjusted Diluted EPS of $10.12, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $1.52 Per Share Related to 2024 Acquired IPR&D and Milestones Expense Delivers Full-Year Net Revenues of $56.334 Billion, an Increase of 3.7 Percent on a Reported Basis and 4.6 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $26.682 Billion, an Increase of 2.1 Percent on a Reported Basis, or 2.9 Percent on an Operational Basis; Global Humira Net Revenues Were $8.993 Billion; Global Skyrizi Net Revenues Were $11.718 Billion; Global Rinvoq Net Revenues Were $5.971 Billion Full-Year Global Net Revenues from the Oncology Portfolio Were $6.555 Billion, an Increase of 10.8 Percent on a Reported Basis, or 12.0 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $3.347 Billion; Global Venclexta Net Revenues Were $2.583 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $8.999 Billion, an Increase of 16.6 Percent on a Reported Basis, or 16.9 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $3.283 Billion; Global Vraylar Net Revenues Were $3.267 Billion; Combined Global Ubrelvy and Qulipta Net Revenues were $1.664 Billion Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.176 Billion, a Decrease of 2.2 Percent on a Reported Basis, or 0.6 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.720 Billion; Global Juvederm Net Revenues Were $1.177 Billion Reports Fourth-Quarter Diluted Loss Per Share of $0.02 on a GAAP Basis, Inclusive of the Recent Partial Intangible Asset Impairment Charge Related to Emraclidine; Adjusted Diluted EPS of $2.16; These Results Include an Unfavorable Impact of $0.88 Per Share Related to Fourth-Quarter 2024 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $15.102 Billion, an Increase of 5.6 Percent on a Reported Basis and 6.1 Percent on an Operational Basis Provides 2025 Adjusted Diluted EPS Guidance Range of $12.12 to $12.32; Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense Reaffirms Expectations for High Single-Digit Compound Annual Revenue Growth Rate through 2029; Raises 2027 Combined Sales Outlook for Skyrizi and Rinvoq to More Than $31 Billion; Updates Outlook for Aesthetics to Deliver High Single-Digit Compound Annual Revenue Growth Rate from 2025 through 2029 NORTH CHICAGO, Ill., Jan. 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2024. "2024 was a year of significant progress for AbbVie. Our growth platform delivered outstanding results, we advanced our pipeline with key regulatory approvals and promising data, and we strengthened our business through strategic transactions," said Robert A. Michael, chief executive officer, AbbVie. "We are entering 2025 with significant momentum and expect net revenues to exceed their previous peak in just the second full year following the U.S. Humira loss of exclusivity." Fourth -Quarter Results Worldwide net revenues were $15.102 billion, an increase of 5.6 percent on a reported basis, or 6.1 percent on an operational basis. Global net revenues from the immunology portfolio were $7.294 billion, an increase of 4.9 percent on a reported basis, or 5.3 percent on an operational basis. Global Humira net revenues of $1.682 billion decreased 49.1 percent on a reported basis, or 48.7 percent on an operational basis. U.S. Humira net revenues were $1.246 billion, a decrease of 54.5 percent. Internationally, Humira net revenues were $436 million, a decrease of 22.7 percent on a reported basis, or 20.5 percent on an operational basis. Global Skyrizi net revenues were $3.778 billion, an increase of 57.7 percent on a reported basis, or 57.9 percent on an operational basis. Global Rinvoq net revenues were $1.834 billion, an increase of 46.2 percent on a reported basis, or 47.1 percent on an operational basis. Global net revenues from the oncology portfolio were $1.691 billion, an increase of 12.0 percent on a reported basis, or 12.9 percent on an operational basis. Global Imbruvica net revenues were $848 million, a decrease of 6.2 percent, with U.S. net revenues of $625 million and international profit sharing of $223 million. Global Venclexta net revenues were $655 million, an increase of 11.0 percent on a reported basis, or 13.0 percent on an operational basis. Global Elahere net revenues were $148 million. Global net revenues from the neuroscience portfolio were $2.509 billion, an increase of 19.8 percent on a reported basis, or 19.9 percent on an operational basis. Global Botox Therapeutic net revenues were $873 million, an increase of 12.5 percent on a reported basis, or 13.0 percent on an operational basis. Global Vraylar net revenues were $924 million, an increase of 17.1 percent. Global Ubrelvy net revenues were $303 million, an increase of 29.6 percent. Global Qulipta net revenues were $201 million, an increase of 76.4 percent on a reported basis, or 76.2 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.298 billion, a decrease of 5.2 percent on a reported basis, or 4.4 percent on an operational basis. Global Botox Cosmetic net revenues were $687 million, a decrease of 4.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $279 million, a decrease of 16.3 percent on a reported basis, or 15.1 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 70.9 percent. The adjusted gross margin ratio was 83.8 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 25.5 percent of net revenues. The adjusted SG&A expense was 23.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 44.9 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues. Acquired IPR&D and milestones expense was 10.4 percent of net revenues. On a GAAP basis, the operating margin in the fourth quarter was negative 9.9 percent. The adjusted operating margin was 34.7 percent. Net interest expense was $610 million. On a GAAP basis, the tax rate in the quarter was 99.0 percent. The adjusted tax rate was 20.2 percent. Diluted loss per share in the fourth quarter was $0.02 on a GAAP basis, inclusive of the recent partial intangible asset impairment charge related to emraclidine. Adjusted diluted EPS, excluding specified items, was $2.16. These results include an unfavorable impact of $0.88 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first novel therapy approved in the European Union (EU) specifically for patients with FRα positive, platinum-resistant ovarian cancer. At the American Society of Hematology (ASH) Annual Meeting, AbbVie announced updated clinical trial results that showed Epkinly (epcoritamab) combination therapy demonstrated high response rates in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL). The company also announced new results from two ongoing clinical trials which showed Epkinly induced durable complete responses as monotherapy and combination treatment in patients with diffuse large B-cell lymphoma (DLBCL). Epkinly is being co-developed by AbbVie and Genmab. AbbVie and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage AbbVie's oncology expertise and EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. AbbVie and Simcere Zaiming announced a partnership to develop a novel trispecific antibody candidate in multiple myeloma (MM). This option-to-license agreement will develop SIM0500, an investigational new drug candidate that is currently in Phase 1 clinical trials in patients with r/r MM. AbbVie and Neomorph announced a collaboration and license agreement that will leverage AbbVie's drug development expertise and Neomorph's leading molecular glue discovery platform to develop novel molecular glue degraders for multiple targets across oncology and immunology. AbbVie announced that it completed its acquisition of Nimble Therapeutics, strengthening AbbVie's pipeline and R&D capabilities. The transaction includes Nimble's lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for the treatment of psoriasis (PsO) as well as Nimble's peptide synthesis, screening, and optimization platform used to help drive rapid discovery and optimization of peptide candidates for a range of targets. AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease (PD). In the study, tavapadon met the primary endpoint, demonstrating a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. Tavapadon also met the key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score. Tavapadon has demonstrated positive results across all three Phase 3 TEMPO trials and AbbVie remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year. AbbVie announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6. Following the results of these trials, AbbVie began an evaluation of the emraclidine intangible asset for impairment which resulted in a significant decrease in the estimated future cash flows for the product. Based on the revised cash flows, the company recorded a non-cash after-tax intangible asset impairment charge of $3.5 billion. AbbVie continues to evaluate information with respect to the Cerevel-related clinical development programs and will monitor the remaining intangible assets of $3.6 billion. AbbVie announced that it completed its acquisition of Aliada Therapeutics. The transaction strengthens AbbVie's neuroscience pipeline and R&D capabilities with the addition of a potential best-in-class disease-modifying therapy for Alzheimer's disease (AD), ALIA-1758, and novel blood-brain barrier (BBB)-crossing technology. Full-Year 2025 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2025 of $12.12 to $12.32. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2025, as both cannot be reliably forecasted. Long-Term Outlook AbbVie is reaffirming its expectations for a high single-digit compound annual revenue growth rate through 2029. This guidance assumes 2024 as the base year in the compound annual growth rate calculation. AbbVie is raising its long-term outlook for Skyrizi and Rinvoq revenues. The company now expects combined Skyrizi and Rinvoq 2027 revenues of more than $31 billion, an increase of approximately $4 billion compared to previous guidance for combined revenues of more than $27 billion in 2027. This guidance assumes Skyrizi revenues of more than $20 billion and Rinvoq revenues of more than $11 billion in 2027. AbbVie is also updating its outlook for aesthetics revenues. The company now expects a high single-digit compound annual revenue growth rate for aesthetics through 2029. This guidance assumes 2025 as the base year in the compound annual growth rate calculation. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our fourth-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2024 and 2023 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3License out/inPhase 1

10 Dec 2024

·synapse.patsnap.com

The Emerging Role and Market Potential of CXCR4 Antagonists in Modern Medicine

Currently, only three CXCR4 (C-X-C motif chemokine receptor 4) antagonists have been approved globally: Plerixafor, Motixafortide, and Mavorixafor, indicating significant market potential. With a deeper understanding of the role of CXCR4 in tumor progression, the demand for CXCR4 antagonists continues to grow. In 2024, the global CXCR4 antagonist market is valued at several billion RMB, with steady growth projected in the coming years. Key players in the global market include Sanofi, BioLineRx, X4 Pharmaceuticals, Eli Lilly, and Roche. The increasing global aging population and the rising incidence of chronic diseases such as cancer create a vast market opportunity for anti-tumor drugs like CXCR4 antagonists. Advances in drug development further inject vitality into the CXCR4 antagonist market. Global Transactions of CXCR4 Antagonists in Patsnap SynapseMechanism of Action of CXCR4 AntagonistsSchematic diagram of CXCR4[1]CXCR4 is a seven-transmembrane G-protein-coupled receptor (GPCR) widely expressed across various cell types, particularly immune cells, hematopoietic stem cells, endothelial cells, and numerous tumor cells. Its primary ligand is the chemokine CXCL12 (also known as SDF-1, stromal cell-derived factor 1). Binding of CXCL12 to CXCR4 induces conformational changes in CXCR4, activating the G-protein complex. The G-protein complex dissociates into Gα and Gβγ subunits, with Gβγ activating the PI3K and RAS-MAPK pathways. CXCL12-CXCR4/CXCR7 signaling pathway[2]Subsequently, the Gβγ subunit activates guanine nucleotide exchange factors (GEFs), such as SOS. These GEFs facilitate the exchange of GDP for GTP on RAS proteins, activating them. Activated RAS proteins, in turn, stimulate the MAPK (mitogen-activated protein kinase) and MEK1/2 (mitogen-activated protein kinase kinase 1/2) pathways. Activated MEK1/2 phosphorylates and activates ERK1/2 (extracellular signal-regulated kinases 1/2). ERK1/2 activation promotes cell proliferation and survival. Additionally, ERK1/2 can activate transcription factors such as c-Fos and c-Jun, further regulating gene expression. Once activated, ERK1/2 enters the nucleus and phosphorylates various transcription factors, including c-Fos and c-Jun, which bind to specific DNA sequences to regulate gene expression, ultimately affecting cell proliferation, differentiation, and survival. When CXCR4 interacts with CXCL12, it activates signaling pathways including RAS-MAPK, PI3K-AKT-mTOR, JAK-STAT, and PLC. These pathways play crucial roles in cell migration, proliferation, and survival. Under normal physiological conditions, CXCR4 is critical for regulating cell migration and localization during development, homeostasis, and inflammation, aiding immune system activation and facilitating cell movement. High CXCR4 expression is associated with poor prognosis and chemotherapy resistance in various cancer subtypes, partly due to enhanced interactions between cancer cells and the stroma. The CXCR4/CXCL12 signaling axis plays a central role in tumor progression through autocrine and paracrine mechanisms. Similar to other GPCRs, CXCR4 undergoes homo- or heterodimerization in its functional signaling regions on the cell surface. Receptor aggregation in dimers or oligomers significantly enhances the sensitivity and intensity of chemokine responses. Schematic representation of the signaling pathways activated by CXCR4[3]CXCR4 antagonists block the binding of CXCL12 to CXCR4, inhibiting tumor cell migration and invasion, reducing HIV infection and transmission, regulating immune cell migration, and promoting hematopoietic stem cell mobilization, showcasing significant applications across multiple fields. In oncology, CXCR4 antagonists like Motixafortide, combined with Keytruda and chemotherapy, have significantly improved objective response rates (ORR) and progression-free survival (PFS) in patients with advanced pancreatic ductal adenocarcinoma and demonstrated antitumor effects in breast and lung cancers. For HIV treatment, CXCR4 antagonists like Plerixafor and AMD3100 reduce viral infection and spread by blocking HIV-CXCR4 interactions while enhancing the host immune response. In autoimmune diseases, CXCR4 antagonists mitigate inflammatory responses by reducing immune cell migration, alleviating symptoms in conditions like systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). In hematopoietic stem cell mobilization, CXCR4 antagonists such as Plerixafor and Motixafortide facilitate the release of hematopoietic stem cells from bone marrow into peripheral blood for autologous transplantation in diseases like non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). Market Drivers for CXCR4 Antagonist DevelopmentWith advancements in precision medicine, targeted therapeutics are increasingly prioritized. As a critical target in various diseases, CXCR4 antagonist development aligns with the precision medicine trend. CXCR4 antagonists hold significant value in treating hematological disorders such as multiple myeloma. Furthermore, these antagonists are being explored for new indications like breast cancer, WHIM syndrome, and Waldenström’s macroglobulinemia, all of which represent substantial patient populations and offer vast market potential. The combination of CXCR4 antagonists with other therapies, such as chemotherapeutics and immune checkpoint inhibitors, markedly enhances therapeutic efficacy and addresses clinical needs. Additionally, governmental and regional policy and financial support for innovative drug development have attracted extensive attention to and support for CXCR4 antagonists as promising innovative drugs. Top 10 Indications of CXCR4 Antagonists in Patsnap SynapseTechnological advancements and innovation have significantly driven the development of CXCR4 antagonists. Novel small-molecule antagonists such as Plerixafor and Mavorixafor, as well as peptide-based antagonists like Motixafortide, have demonstrated high affinity and favorable pharmacological efficacy. The application of antibody-based therapies and nanotechnology has further enhanced drug specificity and effectiveness. Multiple clinical trials have highlighted the substantial efficacy and safety of CXCR4 antagonists across various diseases. Some of these drugs have received FDA designations as Breakthrough Therapies or Fast Track therapies, expediting their development and approval. Targets of CXCR4 Antagonists in Patsnap SynapseRegional Development Analysis of CXCR4 AntagonistsNorth America leads in the development and market adoption of CXCR4 antagonists due to its advanced medical technology and robust regulatory framework. Significant investments from both the U.S. government and private sector have spurred research by major pharmaceutical companies and biotech startups. With a substantial patient population suffering from cancers, HIV infections, immune disorders, and requiring hematopoietic stem cell transplants, demand for CXCR4 antagonists remains strong. Key drugs, including Plerixafor and Mavorixafor, have achieved notable progress in this region. Regional Distribution of CXCR4 Antagonist Research and Development in Patsnap SynapseIn Europe, biopharmaceutical R&D is highly active, with many institutions and companies advancing work on CXCR4 antagonists. While the European Medicines Agency (EMA) maintains stringent drug approval processes, it is continuously optimizing these procedures to accelerate the market entry of innovative medicines. Europe's comprehensive healthcare systems and high patient receptivity to novel therapies drive demand for CXCR4 antagonists in oncology, HIV, immune disorders, and stem cell transplantation. Prominent drugs such as Motixafortide and Balixafortide are undergoing extensive clinical trials in the region. In Asia, particularly in countries like China, Japan, and South Korea, the biopharmaceutical market is expanding rapidly, with increasing demand for innovative drugs. Rich clinical trial resources and a large patient base create favorable conditions for CXCR4 antagonist research. The region exhibits significant potential due to its high prevalence of cancers, HIV infections, immune disorders, and stem cell transplant requirements. Representative drugs, such as Balixafortide, introduced by Fosun Pharma, are undergoing clinical trials for breast cancer. Numerous Asian pharmaceutical companies and research institutions are actively developing various CXCR4 antagonists. Market Competition Landscape for CXCR4 AntagonistsDevelopment Stage Distribution of CXCR4 Antagonists in Patsnap SynapsePlerixafor was the first FDA-approved CXCR4 antagonist, primarily used in autologous hematopoietic stem cell transplantation. Sanofi holds a first-mover advantage in the CXCR4 antagonist market, with a significant market share. The successful application of Plerixafor in stem cell transplantation has provided Sanofi with valuable data and experience, enabling further exploration of additional indications. For instance, Sanofi is investigating the potential of Plerixafor in oncology, particularly in enhancing immune cell infiltration within the tumor microenvironment and improving the efficacy of immunotherapies. Moreover, Sanofi is exploring Plerixafor's application in HIV treatment, aiming to reduce viral infection and transmission by blocking the interaction between HIV and CXCR4. Major Research Institutions for CXCR4 Antagonists in Patsnap SynapseThe CXCR4 antagonist Mavorixafor, the flagship product of X4 Pharmaceuticals, has received FDA priority review designation for the treatment of WHIM syndrome. WHIM syndrome is a rare primary immunodeficiency characterized by recurrent infections, hypogammaglobulinemia, and bone marrow abnormalities. The approval of Mavorixafor represents the first targeted therapy for WHIM syndrome, addressing an unmet medical need. In Phase 3 clinical trials for WHIM syndrome, Mavorixafor demonstrated positive outcomes, including favorable safety and efficacy profiles. These clinical results not only supported its regulatory submission but also bolstered X4 Pharmaceuticals’ market presence and investor confidence. Additionally, X4 Pharmaceuticals is actively exploring the use of Mavorixafor in other conditions, such as HIV infection and certain forms of chronic neutropenia. CXCR4 Antagonist Portfolio of X4 Pharmaceuticals in Patsnap SynapseBioLineRx's Motixafortide has shown remarkable efficacy in the treatment of pancreatic cancer and other malignancies. In collaboration with major pharmaceutical companies such as Merck and Roche, BioLineRx is advancing the development and commercialization of Motixafortide. Clinical trial data indicate that the combination of Motixafortide with Keytruda and chemotherapy significantly improves objective response rates (ORR) and progression-free survival (PFS) in patients. Motixafortide has also demonstrated promising results in autologous hematopoietic stem cell transplantation (ASCT). When combined with granulocyte colony-stimulating factor (G-CSF), Motixafortide substantially enhances the efficiency and quality of CD34+ stem cell collection. In the GENESIS global Phase 3 trial, the combination achieved significantly higher success rates compared to the placebo group, with 88.8% of patients achieving an optimal CD34+ cell dose in a single apheresis session and 92.5% in up to two sessions. Beyond pancreatic cancer and ASCT, BioLineRx is investigating Motixafortide in other oncology applications, including breast cancer, gastric cancer, and prostate cancer. Preliminary findings suggest that Motixafortide enhances antitumor immune responses by blocking CXCR4 receptors, reducing immunosuppressive cells in the tumor microenvironment, and increasing the infiltration of effector T cells and other antitumor immune cells. BioLineRx is also exploring combination therapies involving Motixafortide and other immunotherapies, such as PD-1 inhibitors and chemotherapeutic agents, which have demonstrated synergistic effects in early studies. CXCR4 Antagonist Portfolio of BioLineRx in Patsnap SynapseBioLineRx has established strategic partnerships with major pharmaceutical companies such as Merck and Roche to jointly develop and promote Motixafortide. These collaborations have accelerated the clinical research and market entry of Motixafortide, enhancing its global market presence. For example, BioLineRx partnered with Merck to conduct clinical trials of Motixafortide in combination with Keytruda for the treatment of pancreatic cancer. Additionally, BioLineRx collaborated with China-based Genfleet Therapeutics to develop Motixafortide for the Chinese market. Genfleet is independently responsible for designing and developing first-line combination therapies targeting advanced pancreatic ductal adenocarcinoma in mainland China. This partnership expedites Motixafortide's entry into the Chinese market, addressing the treatment needs of local patients. Fosun Pharma, through its collaboration with Polyphor, introduced Balixafortide for the treatment of breast cancer and other potential cancers. Balixafortide has demonstrated notable efficacy in breast cancer treatment. Clinical trial data from Fosun Pharma showed that Balixafortide, combined with eribulin mesylate injection, exhibited good efficacy and safety in HER2-negative metastatic breast cancer patients. In a global Phase 3 clinical trial, this combination achieved an objective response rate (ORR) of 40%, a median progression-free survival (mPFS) of 8.5 months, and a disease control rate (DCR) of 75%. Fosun Pharma is also exploring the application of Balixafortide in other cancers, such as pancreatic ductal adenocarcinoma (PDAC). According to an announcement by Spexis AG, Balixafortide demonstrated good safety and efficacy in PDAC patients, inhibiting tumor growth and metastasis. Additionally, Fosun Pharma is investigating combination therapies involving Balixafortide and other chemotherapeutic agents. For instance, the combination of Balixafortide with eribulin not only enhanced therapeutic efficacy but also reduced side effects, improving patients' quality of life. This combined therapy strategy offers new approaches to cancer treatment. ConclusionCXCR4 antagonists demonstrate immense potential across various medical fields, particularly in oncology, HIV infection, immune disorders, and hematopoietic stem cell transplantation. Advances in technology and supportive policies have provided robust backing for the development of CXCR4 antagonists, which hold promising market prospects. As more clinical trials are conducted and new drugs are approved, CXCR4 antagonists are poised to become vital tools for treating diverse diseases, offering hope and new options for patients. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery! Refrence 1.Yu, J., X. Zhou, and L. Shen, CXCR4-Targeted Radiopharmaceuticals for the Imaging and Therapy of Malignant Tumors. Molecules, 2023. 28(12).2.Yang, Y., et al., CXCL12-CXCR4/CXCR7 Axis in Cancer: from Mechanisms to Clinical Applications. Int J Biol Sci, 2023. 19(11): p. 3341-3359.3.Bianchi, M.E. and R. Mezzapelle, The Chemokine Receptor CXCR4 in Cell Proliferation and Tissue Regeneration. Front Immunol, 2020. 11: p. 2109.

27 Nov 2024

·www.businesswire.com

AbbVie Digital Transformation Strategy Report 2024 - Accelerators, Incubators and Other Innovation Programs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Enterprise Tech Ecosystem Series: AbbVie Inc. - 2024" company profile has been added to ResearchAndMarkets.com's offering. The report provides insights into AbbVie's tech activities, including its digital transformation strategies, its innovation programs, and its technology initiatives. The report provides information and insights into AbbVie's tech activities, including: Insights of its digital transformation strategies and innovation programs. Overview of technology initiatives covering partnerships and product launches. Insights on each technology initiative including technology theme, objective, and benefits. Details of estimated ICT budgets and major ICT contracts. AbbVie Inc. (AbbVie) is a multi-national, diversified research-based biopharmaceutical company engaged in developing, manufacturing, marketing, and selling medicines for serious and complex diseases. The company's product portfolio includes immunology products, oncology products, aesthetics products, neuroscience products, and eye care products. AbbVie's immunology product portfolio includes Humira, Skyrizi, and Rinvoq. Its oncology product portfolio includes Imbruvica, Venclexta, Epkinly, and Elahere. Its aesthetics product portfolio includes Botox Cosmetic, the Juvederm Collection of Fillers, Alloderm regenerative dermal tissue, and Latisse eyelash solution, among others. Its neuroscience product portfolio includes Botox Therapeutic, Vraylar, Duopa, Ubrelvy, and Qulipta, and its eye care product portfolio includes Ozurdex, Lumigan, Alphagan, and Restasis. The company also manufactures medicines for treating hepatitis C virus infection, metabolic and hormonal diseases, and endocrinology diseases. AbbVie sells its products directly to distributors, wholesalers, healthcare facilities, government agencies, independent retailers, and specialty pharmacies across the world. Reasons to Buy Gain insights into AbbVie's tech operations. Gain insights into its tech strategies and innovation initiatives. Gain insights into its technology themes under focus. Gain insights into various product launches and partnerships. Key Topics Covered: Overview Digital Transformation Strategy Accelerators, Incubators, and Other Innovation Programs Technology Focus Technology Initiatives Partnerships Network Map ICT Budget and Contracts Key Executives A selection of companies mentioned in this report includes: Reltio ConcertAI Caris Life Sciences BigHat Biosciences Cerebras Systems Accenture Pegasystems NowVertical Chronicled MC10 For more information about this company profile visit https://www.researchandmarkets.com/r/2mdpyj 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.

100 Deals associated with Ubrogepant

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KEGG	Wiki	ATC	Drug Bank
D10673	Ubrogepant	N02C	DB15328

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Approved

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	AbbVie, Inc.	23 Dec 2019

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Without Aura	Phase 3	United States	AbbVie, Inc.	13 Jan 2022
Migraine Without Aura	Phase 3	Puerto Rico	AbbVie, Inc.	13 Jan 2022
Acute migraine	Phase 2	-	Allergan UC	01 Jul 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05264129 (TANDEM, CTgov)	Phase 4	Migraine Disorders	263	Atogepant (Atogepant 60 mg (Period 1))	lpqckhlasf = sxndkgebam hknlhnlgqb (rrxujnrqkd, reseiyrmni - qkkiabdmlo) View more	-	08 Oct 2024
				Atogepant+Ubrogepant (Atogepant 60 mg + Ubrogepant 100 mg (Period 2))	lpqckhlasf = hdurggwrkm hknlhnlgqb (rrxujnrqkd, imzhocwuwx - flksfyvaoa) View more
NCT04492020 (PRODROME, Literature) Manual	Phase 3	Migraine Disorders	518	Ubrogepant	xdrbkiaspq(yuuqvqqgxk): OR = 1.66 (95% CI, 1.40 - 1.96), P-Value = < 0.0001 View more	Positive	28 Aug 2024
				Placebo
NCT05264129 (TANDEM, AAN2024)	Phase 4	Migraine Disorders \| Acute migraine calcitonin gene-related peptide (CGRP) receptor antagonist	263	Atogepant 60mg QD	ldunrslqij(ktpfdcklql) = 8.4% vs 3.2% sznrtqiasg (ehladofkoy ) View more	Positive	09 Apr 2024
				Ubrogepant 100mg PRN
AAN2024	Phase 1	Migraine Disorders	8	Ubrogepant 100 mg	auclyrjbwc(hfsuvjrkdw) = vxxdjsdpzq twrzeogzrc (viguehcsza )	Positive	09 Apr 2024
NCT04492020 (PRODROME, Literature \| Pubmed \| Lancet) Manual	Phase 3	Migraine Disorders	518	Ubrogepant	ryydffgpmh(jpwnundsny) = zljprqstog qaktfzsjke (yznujwvlvk ) View more	Positive	15 Nov 2023
				placebo	ryydffgpmh(jpwnundsny) = tncuwwtedb qaktfzsjke (yznujwvlvk ) View more
NCT04492020 (PRODROME, AAN2023)	Phase 3	Migraine Disorders calcitonin gene-related peptide (CGRP) receptor	-	Ubrogepant 100 mg	pkytkoucsg(pjxbuxdygl) = qztbahmjag hrtarlvsmc (lkxlvgdizf ) View more	-	25 Apr 2023
				Placebo	pkytkoucsg(pjxbuxdygl) = bdkicbxvpw hrtarlvsmc (lkxlvgdizf ) View more
NCT03461757 \| NCT02828020 \| NCT02867709 \| NCT02439320 \| NCT02605174 (Pubmed \| Clin J Pain)	Phase 3	Migraine Disorders	-	Rimegepant 75 mg	xfuoosgymt(qsxtkzuxxj) = gtuirhyuwa mzlvlpzzrn (ylesgnuucb, 5 - 12) View more	-	01 Nov 2022
				Ubrogepant 100 mg	jgrwtpwbov(krqrojkngq) = rfplskknxc isxsqnmaay (xbbnjauuqk, 4 - 8)
NCT02873221 (Pubmed)	Phase 3	Migraine Disorders	808	Ubrogepant-50mg	dzqtmoosqy(dcnsmnyytt) = voqjpmbzmd vpikixqfzp (ikjesxnnav )	-	17 Aug 2022
				Ubrogepant-100mg	dzqtmoosqy(dcnsmnyytt) = exqeuclaqc vpikixqfzp (ikjesxnnav )
NCT02873221 (AAN2022)	Phase 3	Headache	-	Ubrogepant 50 mg	kejaxlxybh(mwbrsjvcmf) = cpwlwpqusw uvzswakxyl (lxjmdykskx ) View more	-	03 May 2022
				Ubrogepant 100 mg	kejaxlxybh(mwbrsjvcmf) = hbgathhgjo uvzswakxyl (lxjmdykskx ) View more

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