A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age

The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008

Start Date06 Dec 2024

Sponsor / Collaborator

UCB BioSciences, Inc.

NCT06692192 / Not yet recruitingPhase 1

Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)

The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.
Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.
Participants will:
* Receive one of four possible combinations of medications
* Undergo an MRI
* Complete questionnaires
* Undergo transcranial magnetic stimulation (TMS) and EEG

Start Date01 Dec 2024

Sponsor / Collaborator

University of Wisconsin Madison

CTRI/2024/11/076409 / Not yet recruitingNot ApplicableIIT

The pain reaction of children under midazolam sedation to local anesthesia administered with a disposable vs a cartridge syringe a randomized controlled trial - NIL

Start Date20 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Midazolam

100 Translational Medicine associated with Midazolam

100 Patents (Medical) associated with Midazolam

15,301

Literatures (Medical) associated with Midazolam

01 Apr 2025·DEN Open

Comparison of propofol‐based sedation and midazolam sedation in pediatric bidirectional endoscopy conducted by pediatric gastroenterologists

Article

Author: Kudo, Takahiro ; Horiuchi, Akira ; Nishimoto, Satomi ; Horiuchi, Ichitaro ; Ukai, Satoshi ; Kurasawa, Shingo

AbstractObjectivesThe effectiveness and safety of propofol‐based sedation and midazolam sedation in pediatric bidirectional endoscopy were compared.MethodsWe retrospectively analyzed the cases of pediatric patients (≤15 years old) who had undergone bidirectional endoscopy, esophagogastroduodenoscopy, and colonoscopy by pediatric gastroenterologists. Demographic data, indications, sedatives/dosages, clinical outcomes, endoscopic findings, adverse events, and total patient time requirements (total time in which patients stay in our hospital) were compared in the two sedation groups.ResultsNinety‐one children (51 boys, 40 girls, mean age 13 years, range 9–15) treated at our hospital were enrolled. Propofol alone or in combination with midazolam and/or pentazocine was administered to 51 patients (propofol‐based sedation group). Midazolam alone or in combination with pentazocine was administered to the other 40 patients (midazolam sedation group). In the propofol group, the following mean doses were used: propofol, 96 mg (range 40–145 mg); midazolam, 4.9 mg (range 3–5 mg); and pentazocine, 7.5 mg. In the midazolam group, the mean doses of midazolam and pentazocine were 6.2 mg (range 4–10 mg) and 15 mg, respectively. All procedures were successfully completed by pediatric gastroenterologists. The total procedure times and endoscopic findings were similar in the two groups, but the median patient time requirement in the propofol group was significantly shorter versus the midazolam group (7.3 h vs. 8.4 h, p < 0.001). No adverse events occurred in either group.ConclusionsPropofol‐based sedation in pediatric bidirectional endoscopy was safely and effectively performed by pediatric gastroenterologists, and its patient time requirement was shorter than that for midazolam sedation.

01 Apr 2025·DEN Open

Prophylactic effect of compression stockings for elevated D‐dimer levels following endoscopic submucosal dissection

Article

Author: Miura, Ryo ; Yamamoto, Takatsugu ; Arizumi, Toshihiko ; Tanaka, Atsushi ; Harada, Fumito ; Aoki, Naoaki ; Abe, Koichiro ; Honda, Taku ; Kodashima, Shinya ; Isono, Akari ; Asaoka, Yoshinari ; Sakurai, Miyoko ; Ikusaka, Ken ; Maruyama, Kyohei ; Aoyagi, Hitoshi ; Shimizu, Yuki

AbstractObjectivesA relationship between endoscopic submucosal dissection (ESD) and deep vein thrombosis has been recognized. We previously reported that a high corrected midazolam dose (total midazolam dose/initial dose of midazolam used to induce sedation) is related to elevated D‐dimer levels after ESD. In this study, the effect of compression stockings (CSs) in preventing thrombosis following ESD under sedation was evaluated by measuring D‐dimer levels before and after ESD.MethodsThe participants were patients who underwent ESD for upper gastrointestinal tumors during the period between April 2018 and October 2022. Patients with pre‐ESD D‐dimer levels ≥1.6 µg/m and patients with corrected midazolam doses ≤3.0 were excluded. A retrospective investigation of the relationship between CS use and high post‐ESD D‐dimer levels (difference in D‐dimer levels ≥1.0 µg/mL between before and after ESD) was conducted.ResultsThere were 27 patients in the non‐CS group (NCS) and 33 patients in the CS group. The number of patients with high post‐ESD D‐dimer levels was 13 (48.2%) in the non‐CS group and six (18.2%) in the CS group; the number in the CS group was significantly lower (p = 0.024). On logistic regression analysis, a relationship was seen between the wearing of CSs and a lower number of patients with high post‐ESD D‐dimer levels (odds ratio 0.24, 95% confidence interval 0.08–0.79, p = 0.019).ConclusionWearing CSs was related to a lower risk of high post‐ESD D‐dimer levels. This result suggests that thrombus formation is a cause of elevated D‐dimer levels after ESD.

01 Apr 2025·DEN Open

Comparison of remimazolam and midazolam for sedation during colonoscopy in Japanese patients: A propensity score matching analysis

Article

Author: Ikehara, Hisatomo ; Ogura, Kanako ; Ono, Hiroyuki ; Kanmura, Yuichi ; Sumiyoshi, Tetsuya ; Esaki, Mitsuru ; Kiriyama, Shinsuke ; Nagata, Yasuhiko ; Ichijima, Ryoji ; Minoda, Yosuke ; Yamaguchi, Daisuke ; Sugita, Tomomi ; Hotta, Kinichi

AbstractObjectivesTo compare the efficacy and safety of sedation with midazolam and remimazolam for colorectal endoscopy.MethodsThis single‐center, two‐arm, post‐hoc analysis of the REM‐IICTJP01 study investigated the efficacy and safety of remimazolam for gastrointestinal endoscopic sedation. We enrolled 40 and 208 patients who underwent colonoscopy under remimazolam and midazolam sedation, respectively, during the same period. The primary outcome was the time from the end of the colonoscopy until discharge. The secondary outcomes included the time from the end of the colonoscopy until awakening, dosage, and adverse events. Propensity score matching was employed to eliminate the effect of confounding factors.ResultsThirty‐seven patients in each group were matched. After propensity matching, the time to awakening after colonoscopy was 28.0 (13.0–37.0) min in the midazolam group and 0 (0–0) min in the remimazolam group; moreover, the time till discharge was 40.0 (35.0–46.5) min in the midazolam group and 0 (0–5.0) min in the remimazolam group, both of which were significantly shorter in the remimazolam group (p < 0.01). The number of additional doses was 0 (0–0) and 2 (1–3) in the midazolam and remimazolam groups, respectively. The total dose was 2.0 (2.0–3.5) and 6.0 (5.0–7.0) mg in the midazolam and remimazolam groups, respectively.ConclusionsRemimazolam yielded significantly faster times to awakening and discharge safely compared to midazolam.

News (Medical) associated with Midazolam

30 Oct 2024

·www.globenewswire.com

Arvinas Reports Third Quarter 2024 Financial Results and Provides Corporate Update

– On track to report topline data from Phase 3 VERITAC-2 trial in 4Q24 or 1Q25 – – Initial clinical data from Phase 1/2 TACTIVE-U sub-study of abemaciclib in combination with vepdegestrant to be presented at San Antonio Breast Cancer Symposium in December 2024 – – Recently presented new preclinical data for the PROTAC LRRK2 degrader ARV-102 demonstrating that LRRK2 degradation affects biomarkers in the CSF – - $1.1 billion in cash, cash equivalents and marketable securities as of Sept. 30, 2024 - – Company to host conference call today at 8:00 a.m. ET – NEW HAVEN, Conn., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update. “We maintained strong momentum across our portfolio in the third quarter and remain on track to report topline data from VERITAC-2, our Phase 3 clinical trial in metastatic breast cancer, in the fourth quarter of 2024 or the first quarter of 2025,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “In partnership with our colleagues at Pfizer, we are excited by the possibility of changing the treatment paradigm for ER+/HER2- breast cancer and look forward to sharing results from VERITAC-2 in the coming months.” “Our path to reaching our goal of becoming a multi-product, commercial-stage organization with a robust pipeline across several indications is clearly defined, and our novel PROTAC platform technology has the potential to enable opportunities across multiple therapeutic areas,” continued Dr. Houston. “We look forward to completing the multiple ascending dose portion of our Phase 1 clinical trial with ARV-102, our first PROTAC degrader with the potential to treat neurodegenerative diseases, and sharing data in 2025. We are also encouraged by the preclinical profile of ARV-393, our BCL6 PROTAC degrader currently being evaluated in a first-in-human Phase 1 clinical trial in patients with B-cell lymphomas. We look forward to sharing more about these programs in the coming months.” 3Q 2024 Business Highlights and Recent Developments Vepdegestrant Continued enrollment globally in multiple clinical studies of vepdegestrant in ER+/HER2- metastatic breast cancer. VERITAC-2: Phase 3 monotherapy clinical trial in patients with metastatic breast cancer (ClinicalTrials.gov Identifier: NCT05654623)TACTIVE-U: Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522).TACTIVE-K: Phase 1/2 clinical trial with vepdegestrant plus Pfizer’s novel CDK4 inhibitor atirmociclib (ClinicalTrials.gov Identifier: NCT06206837) ARV-102: Oral PROTAC LRRK2 degrader In October, presented preclinical data at the 2024 Michael J. Fox Foundation Parkinson’s Disease Conference further supporting the potential of PROTAC-induced leucine-rich repeat kinase 2 (LRRK2) degradation as a potential treatment for patients with neurodegenerative diseases. New findings presented included data demonstrating: Orally delivered ARV-102 crosses the blood-brain barriers and degrades LRRK2 in the cerebrospinal fluid (CSF) of non-human primates (NHPs).Degradation of LRRK2 by ARV-102 induces changes in pathway (lysosomal and inflammation) biomarkers in the CSF of NHPs, which has not previously been demonstrated by kinase inhibitors of LRRK2.In murine tauopathy models, oral PROTAC LRRK2 degrader treatment led to ~50% pathologic tau reduction. Initiated the multiple ascending dose portion of the ongoing Phase 1 clinical trial in healthy volunteers. ARV-393: Oral PROTAC BCL6 degrader Continued recruiting patients in the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas. Anticipated Upcoming Milestones and Expectations Vepdegestrant As part of Arvinas global collaboration with Pfizer, the companies plan to: Complete enrollment (4Q24) and announce topline data (4Q24/1Q25) for the VERITAC-2 Phase 3 monotherapy clinical trial in patients with metastatic breast cancer.Present initial safety and pharmacokinetic data from the TACTIVE-U sub-study (NCT05548127) of abemaciclib in combination with vepdegestrant at the San Antonio Breast Cancer Symposium (SABCS) in December 2024.Present data from the Phase 1 healthy volunteer pharmacokinetic trial of vepdegestrant in combination with midazolam to assess potential for drug-drug interaction at SABCS in December 2024 (NCT06256510).Continue enrollment of the ongoing Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (TACTIVE-U; ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522).Evaluate data from the study lead-in of the VERITAC-3 Phase 3 trial (NCT05909397) in patients with ER+/HER2- locally advanced or metastatic breast cancer (2H24).Continue enrollment and evaluate preliminary data from the ongoing clinical trial with vepdegestrant plus Pfizer’s novel CDK4 inhibitor atirmociclib (TACTIVE-K).Start Phase 3 combination trials in the first- and second-line settings (anticipated in 2025; pending emerging data and regulatory feedback). First-line setting with vepdegestrant plus atirmociclib or palbociclib.Second-line setting with vepdegestrant plus palbociclib and/or another CDK4/6 inhibitor. ARV-102: Oral PROTAC LRRK2 degrader Complete enrollment in the ongoing multiple ascending dose portion of a Phase 1 trial evaluating ARV-102 in healthy volunteersPresent data from the Phase 1 trial in 2025. ARV-393: Oral PROTAC BCL6 degrader Continue recruiting patients in the first-in-human Phase 1 clinical trial evaluating ARV-393 in patients with B-cell lymphomas. Novel PROTAC KRAS G12D degrader File an Investigational New Drug (IND) application in 2025. Financial GuidanceBased on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of September 30, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027. Third Quarter Financial Results Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2024, cash, cash equivalents and marketable securities were $1,121.6 million as compared with cash, cash equivalents, restricted cash and marketable securities of $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents and marketable securities of $144.9 million for the nine months ended September 30, 2024 was primarily related to cash used in operations of $158.1 million (net of $150.0 million received from the Novartis agreements), inclusive of a one-time cash termination fee in the amount of $41.5 million related to the termination of our laboratory and office space lease with 101 College Street LLC in August 2024 and the purchase of lab equipment and leasehold improvements of $1.5 million, partially offset by proceeds from the exercise of stock options of $7.7 million and unrealized gains on marketable securities of $7.2 million. Research and Development Expenses: Research and development expenses were $86.9 million for the quarter ended September 30, 2024, as compared with $85.9 million for the quarter ended September 30, 2023. The increase in research and development expenses of $1.0 million for the quarter was primarily due to an increase in compensation and related personnel expenses of $2.8 million, which are not allocated by program, partially offset by a decrease in external expenses of $2.2 million. External expenses include program-specific expenses, which decreased by $1.1 million, primarily driven by decreases in our ARV-766 and ARV-110 programs of $3.8 million and $1.6 million, respectively, partially offset by increases in our ARV-102 and ARV-393 programs of $2.5 million and $1.4 million, respectively, and our non-program specific expenses, which decreased by $1.1 million. General and Administrative Expenses: General and administrative expenses were $75.8 million for the quarter ended September 30, 2024, as compared with $22.6 million for the quarter ended September 30, 2023. The increase in general and administrative expenses of $53.2 million for the quarter was primarily due to a loss on the termination of our laboratory and office space lease with 101 College Street LLC of $43.4 million as well as increases in personnel and infrastructure related costs of $5.0 million, professional fees of $3.4 million and in developing our commercial operations of $1.2 million. Revenue: Revenue was $102.4 million for the quarter ended September 30, 2024 as compared with $34.6 million for the quarter ended September 30, 2023. Revenue for the quarter is related to the license agreement with Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the collaboration and license agreement with Bayer and the collaboration and license agreement with Pfizer. The increase in revenue of $67.8 million was primarily due to revenue from the Novartis license agreement of $76.7 million, offset by a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $7.6 million related to timing differences in clinical trials and program expenses and a decrease in revenue from Bayer of $1.1 million related to the termination of the Bayer Collaboration Agreement in August 2024. Investor Call & Webcast Details Arvinas will host a conference call and webcast today, October 30, 2024, at 8:00 a.m. ET to review its third quarter 2024 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days. About VepdegestrantVepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC® (PROteolysis Targeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the expected timing in connection with the completion of enrollment and reporting of topline data from the VERITAC-2 clinical trial; the potential to change the treatment paradigm for ER+/HER2- breast cancer; the goal of becoming a multi-product, commercial-stage organization with a robust pipeline across several indications; novel PROTAC platform technology having the potential to enable opportunities across multiple therapeutic areas; plans to present initial safety and pharmacokinetic data from the TACTIVE-U sub-study of abemaciclib in combination with vepdegestrant at SABCS; plans to present data from the Phase 1 healthy volunteer pharmacokinetic trial of vepdegestrant in combination with midazolam at SABCS; plans to continue enrollment in the TACTIVE-U study and evaluate data from the study lead-in of the VERITAC-3 Phase 3 clinical trial; plans to continue enrollment and evaluate preliminary data from the TACTIVE-K clinical trial; the expected timing of initiation of Phase 3 vepdegestrant combination trials in the first- and second-line settings, pending emerging data and regulatory feedback; expected timing of filing an investigational new drug application for a KRAS G12D degrader; plans to compete enrollment in the multiple ascending dose portion of the ARV-102 Phase 1 clinical trial, the timing of the presentation of data from such clinical trial, and the timing of sharing additional information about the program; plans to continue recruiting patients in the Phase 1 ARV-393 clinical trial and timing of sharing additional information about the program; and statements regarding Arvinas’ cash, cash equivalents and marketable securities. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: Arvinas’ and Pfizer’s performance of the respective obligations with respect to Arvinas’ collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials and preclinical studies on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release. ContactsInvestors:Jeff Boyle+1 (347) 247-5089Jeff.Boyle@arvinas.com Media:Kirsten Owens+1 (203) 584-0307Kirsten.Owens@arvinas.com Arvinas, Inc.Condensed Consolidated Balance Sheets (Unaudited) (dollars and shares in millions, except per share amounts)September 30, 2024December 31,2023Assets Current assets: Cash and cash equivalents$85.2 $311.7 Restricted cash — 5.5 Marketable securities 1,036.4 949.3 Accounts receivable 7.3 — Other receivables 7.5 7.2 Prepaid expenses and other current assets 13.1 6.5 Total current assets 1,149.5 1,280.2 Property, equipment and leasehold improvements, net 6.8 11.5 Operating lease right of use assets 1.0 2.5 Collaboration contract asset and other assets 9.8 10.4 Total assets$1,167.1 $1,304.6 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued liabilities$75.9 $92.2 Deferred revenue 199.2 163.0 Current portion of operating lease liabilities 0.8 1.9 Total current liabilities 275.9 257.1 Deferred revenue 304.5 386.2 Long-term debt 0.6 0.8 Operating lease liabilities 0.1 0.5 Total liabilities 581.1 644.6 Stockholders’ equity: Preferred stock, $0.001 par value, zero shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively — — Common stock, $0.001 par value; 68.7 and 68.0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 0.1 0.1 Accumulated deficit (1,486.5) (1,332.7)Additional paid-in capital 2,068.3 1,995.7 Accumulated other comprehensive income (loss) 4.1 (3.1)Total stockholders’ equity 586.0 660.0 Total liabilities and stockholders’ equity$1,167.1 $1,304.6 Arvinas, Inc.Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended September 30,Nine Months Ended September 30,(dollars and shares in millions, except per share amounts) 2024 2023 2024 2023 Revenue$102.4 $34.6 $204.2 $121.6 Operating expenses: Research and development 86.9 85.9 264.9 284.5 General and administrative 75.8 22.6 131.3 73.3 Total operating expenses 162.7 108.5 396.2 357.8 Loss from operations (60.3) (73.9) (192.0) (236.2)Interest and other income, net 11.7 10.0 39.2 25.5 Net loss before income taxes and loss from equity method investment (48.6) (63.9) (152.8) (210.7)Income tax (expense) benefit (0.6) — (1.0) 0.7 Loss from equity method investment — (0.1) — (2.5)Net loss$(49.2)$(64.0)$(153.8)$(212.5)Net loss per common share, basic and diluted$(0.68)$(1.18)$(2.14)$(3.97)Weighted average common shares outstanding, basic and diluted 72.1 54.1 71.9 53.6

Phase 1Financial StatementLicense out/inPhase 3Fast Track

16 Jul 2024

·www.prnewswire.com

Benzodiazepine Drugs Market to Reach US$ 3.2 Billion by 2034, Growing at 3.5% CAGR | Impact of Psychological Conditions and Aging Population - Reports TMR

Benzodiazepine drugs are vastly used as psychoactive drugs, which can be used to control seizures, alcohol withdrawal symptoms, and other issues related to the psychological conditions of a human being. With the activity of drugs closely related to brain stimulation, the drug can act as a relaxant for muscles in the body. WILMINGTON, Del., July 16, 2024 /PRNewswire/ -- Owing to different governing factors, the development of the benzodiazepine drug market is expected to traverse a sluggish path of advancement during the forecasted period. With a CAGR of 3.5%, the industry will proceed to reach USD 3.2 billion by 2034. The last recorded size of the ecosystem was USD 2.2 billion in 2023. With the changing lifestyles and mounting pressures to cope with an accelerated pace of living, many people have been facing psychological issues. The growing prevalence of trauma, anxiety, mental fatigue, and many other psychological conditions is observed to have increased recently. To treat such medical conditions, an appropriate relaxant must be applied to get the desired results. This growing prevalence is a clear sign of an important driver that promises to elevate the size of the competitive space during the forecasted period. The rising geriatric population is contributing to the growing cases of insomnia. Along with the abovementioned factors, the growing senior population is trying to find solutions for issues like sleep deprivation. To cater to such issues, the use of benzodiazepine drugs is observed to have increased. Propel Your Business Success: Secure Your Sample of Our Latest Report Now! Due to the sedative properties of drugs, the use of such chemicals is observed to have gained traction in the case of muscle relaxants. To cater to such muscle spasms and other related issues, such drugs can be effective. This factor drives the sales of such drugs. With the spurring of innovation and growth in the technological infrastructure, product augmentation has become possible. Key players in the ecosystem invest more in innovation to alter formulations of drugs. This elevates drug delivery and response time, delivering better results. Rising investments in the pharmaceutical and healthcare industries have generated better prospects for leading organizations. As more market openings have been created in the industry, the scope of expanding the market increases for key players, benefitting the size of the industry. The growing research and development activities are expected to augment the drug efficacy and efficiency, which will likely benefit the industry. Due to this, such efforts have been fueling the industry's progress, creating opportunities for new entrants. Benzodiazepine Drugs Market Report Scope: Key Findings from the Market Report The competitive landscape of benzodiazepine drugs can be segmented into different categories depending on various parameters. Based on the drug type, Alprazolam is used to control anxiety issues. The drug controls an abnormal excitement in the brain. Based on the application segment, anxiety is the largest shareholder in the industry. Due to the changing lifestyle, such cases are increasing at an alarming rate, gaining more demand for the segment. Based on the time of use, various prolonged cases of such drugs are seen to have gained momentum. Curing deep psychological impacts is surging the demand for the segment. Based on the end-user, hospital pharmacies govern the largest market share due to better availability of drugs. Regional Profile The growing awareness of psychological health in Asia-Pacific is creating better prospects for the global benzodiazepine drug market. With the growing drug research activities in Europe, the demand for such drugs will likely increase due to a larger canvas. The progress of the healthcare and pharmaceutical industry in North America is a key factor in helping the region lead the global landscape. Competitive Landscape Among different firms expanding in the industry, Pfizer Inc. is a key player that produces different products to expand. Such products include aminophylline, etomidate, argatroban injection, and many more. UCB S.A. is another important player producing solutions for Briviact (brivaracetam) Epilepsy, Ankylosing spondylitis, and Myasthenia Gravis. Hikma Pharmaceuticals PLC operates in different verticals, including injectables, oral drugs, and other segments. Key Developments in the Benzodiazepine Drug Market In December 2023, Pfizer Inc. acquired Seagen. This move bolstered the position of the organization in the industry. In March 2024, UCB S.A. invested in IMIDomics, Inc. to innovate solutions for immune-mediated inflammatory diseases. This product launch helped the business augment products, bolstering the position in the market. Key Players Pfizer Inc. UCB S.A. Hikma Pharmaceuticals PLC Teva Pharmaceutical Industries Ltd. H.Lundbeck A/S Apotex Inc. Aurobindo Pharma Purdue Pharma Other Prominent Players Market Segmentation Drug Type Alprazolam Clonazepam Diazepam Lorazepam Others (Midazolam, etc.) Application Anxiety Insomnia Alcohol Withdrawal Seizures Others (Bipolar Disorder, etc.) Time of Action Ultra-short Acting Short Acting Long Acting End User Hospital Pharmacies Retail Pharmacies Online Pharmacies Region North America Europe Asia Pacific Latin America Middle East & Africa Drive Your Business Growth Strategy: Purchase the Report for Key Insights! Have a Look at Related Research Reports of Pharmaceutical Cardiovascular Drugs Market - The global cardiovascular drugs market, valued at USD 142.8 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 3.8% from 2023 to 2031. This growth trajectory is expected to elevate the market size to USD 195.6 billion by the end of 2031, driven by increasing prevalence of cardiovascular diseases, advancements in drug development, and rising healthcare expenditures globally. Insomnia Market - The global insomnia industry was worth US$ 3.8 billion in 2022. From 2023 to 2031, it is expected to increase at a CAGR of 6.0%, reaching US$ 6.4 billion. Various therapies have been explored for managing insomnia, offering non-pharmacological alternatives for those seeking sleep improvement. Bioengineered Protein Drugs Market - Rise in incidence of chronic diseases such as infectious diseases, autoimmune disorders, and cancer is a dominating factor contributing to the bioengineered protein drugs market growth. About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyses information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. Contact: Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Email: [email protected] Follow Us: LinkedIn | Twitter | Blog | YouTube Logo: SOURCE Transparency Market Research

Acquisition

12 Jul 2024

·www.pharmaceutical-technology.com

Crossject secures funding from French Government for needle-free platform

Crossject’s single-use prefilled device propels medicine through the skin in less than one tenth of a second. Credit: Crossject. French company Crossject has secured €6.9m in funding to advance the development of ZENEO Epinephrine, its prefilled needle-free platform and treatment for severe allergic reactions. Crossject received funds from the French Government as part of the “i-Démo” call for projects under the France 2030 Plan, operated by Bpifrance on behalf of the government. ZENEO Epinephrine is expected to generate cumulative sales of around €1bn by 2032 for Crossject and its distributors, according to the 11 July announcement. The company’s needle-free platform is designed to enable patients or untrained caregivers to deliver a range of emergency drugs via intramuscular (IM) injection on the skin or through clothing. According to Crossject, the single-use device propels the medicine through the skin in less than a tenth of a second. Speaking to Pharmaceutical Technology , Crossject’s CEO Patrick Alexandre said that this is an advantage over other needle-based systems on the market, which take more time in emergencies and have more variability in dosing. See Also: Mabwell’s 9MW2821 gains FDA fast track status for breast cancer AstraZeneca’s Tagrisso gains approval in Canada for NSCLC “It takes less than one minute to understand and perform the injection, which is key for an emergency,” explained Alexandre. The drug solution inside ZENEO Epinephrine uses a sulfite-free formulation. Sulfites are used as preservatives in many products and can cause intolerance or even additional allergic reactions such as anaphylactic shock. According to Alexandre, this new solution – which replaces sulfite with vitamin E – minimises additional allergy risks to patients. As well as ZENEO Epinephrine, the company has other assets such as ZEPIZURE, a rescue therapy for epileptic seizures. In 2022, Crossject teamed up with the US Biomedical Advanced Research and Development Authority (BARDA), which placed an initial $60m order for ZEPIZURE once it gained US Food and Drug Administration (FDA) approval. BARDA funded a study of midazolam, the drug used in ZEPIZURE. “When we decided to develop a drug-device combination, we first choose drugs that are already used in a specific indication – for example, midazolam is already a first choice as an intramuscular injection in case of epileptic seizures,” said Alexandre. Data from the RAMPART study demonstrated IM midazolam’s non-inferiority compared to intravenous lorazepam, as its primary endpoint. In a bioequivalence study from Crossject, ZEPIZURE was equivalent to the IM injection from a syringe equipped with a 30mm needle. The company plans to file marketing authorisation applications for ZENEO Epinephrine in 2026 with regulatory authorities in Europe and the US. According to GlobalData analysis , Crossject is a key player involved in the active development of needle-free injections. GlobalData is the parent company of Pharmaceutical Technology. Needle-free delivery mechanisms are increasing in popularity, offering an alternative to traditional needles which can require training to administer. In November 2023, US-based Micron Biomedical received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

Drug ApprovalFast TrackVaccine

100 Deals associated with Midazolam

External Link

KEGG	Wiki	ATC	Drug Bank
D00550	Midazolam	N05CD08	DB00683

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Epilepsy	US	UCB, Inc.	17 May 2019
Status Epilepticus	JP	Alfresa Pharma Corp.	26 Sep 2014
Sedation	CN	Jiangsu Nhwa Pharmaceutical Co., Ltd.	01 Jan 1998
Anesthesia	JP	Maruishi Pharmaceutical Co., Ltd.	29 Mar 1988

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute repetitive seizure	Phase 1	ES	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Phase 1	IT	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Phase 1	NZ	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Phase 1	IL	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Phase 1	US	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Preclinical	PL	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Preclinical	CA	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Preclinical	HU	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Preclinical	UA	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Preclinical	DE	UCB Biopharma SRL	01 Jun 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05526911 (CTgov)	Phase 1	Pulmonary Tuberculosis \| Tuberculosis, Multidrug-Resistant	28	Digoxin+Midazolam+TBAJ-876	auwgymdyrc(niwxbduasq) = sytyxapkkq vnjmpzrrms (qcrounbdpg, mhjwnnsstv - dbmvfypbzl) View more	-	08 Oct 2024
NCT05126459 (CTgov)	Phase 3	Dental Caries	60	Meperidine+Hydroxyzine +Midazolam (Regimen 1)	hvicjmwicm(xduirhocoo) = vhtazlvdnu dbuwaafjme (qifmlfxrzc, itwnnbakpm - pwtcuotfsw) View more	-	02 Oct 2024
				Meperidine+Hydroxyzine (Regimen 2)	hvicjmwicm(xduirhocoo) = osgdfxfpgu dbuwaafjme (qifmlfxrzc, dkgflqcpjc - itslqxsuld) View more
NCT03864042 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| Metastatic melanoma \| Unresectable Melanoma \| BRAF V600 mutation-positive Melanoma	56	omeprazole+encorafenib+midazolam+caffeine+binimetinib+dextromethorphan+losartan (Arm 1 - CYP Probe Cocktail)	kqcncdxlbh(zqgojswory) = tijqmedrsc lsvqgbtyqg (xmtmuupalh, mprddlvhgb - xzkzzvbnci) View more	-	27 Sep 2024
				rosuvastatin+bupropion immediate release (IR)+encorafenib+binimetinib (Arm 2 - Rosuvastatin and Bupropion)	nliipcojva(ldkndnmznq) = hmogkbnwtf hvsxxsljvp (rqmvzgrxca, qzehzehjvs - quvznjujwk) View more
DDW2024	Not Applicable	-	250	Midazolam	mlacdarqht(ekjnthbgay) = kqezmkawqa svminuieso (eripbekjik )	Positive	20 May 2024
				Propofol	mlacdarqht(ekjnthbgay) = cezxqlutcx svminuieso (eripbekjik )
DDW2024	Not Applicable	-	-	Midazolam	dyzwruaicq(ajirfvrpbr) = jbmcugwees sxitorjzrk (fwvyjfgoeg )	-	20 May 2024
				Propofol	dyzwruaicq(ajirfvrpbr) = ocgcknzeqn sxitorjzrk (fwvyjfgoeg )
DDW2024	Not Applicable	-	250	Midazolam	wwoqlqrfhr(xgfypcontr) = utpxteltbu jgadhaffgr (zjcueyklie )	Positive	20 May 2024
				Propofol	wwoqlqrfhr(xgfypcontr) = zjilzxqwqy jgadhaffgr (zjcueyklie )
NCT04051827 (CTgov)	Phase 1	Advanced Lung Non-Small Cell Carcinoma	26	Midazolam (Part A: Midazolam Alone)	nwrhxsktcy(dplpodazzh) = wvxiuiybit gfpvblnilr (ilkcgxtdzr, gwteqqlfyw - ujvrkgowde) View more	-	12 Apr 2024
				Midazolam+Mobocertinib (Part A: Midazolam + Mobocertinib)	nwrhxsktcy(dplpodazzh) = bphuzrzojy gfpvblnilr (ilkcgxtdzr, trhzdaldqk - glpzzeqzsi) View more
ESC2024	Not Applicable	Tachycardia, Supraventricular	-	Dexedetomidine	mveetgaakx(ajzoortdbn) = jhycemtqia pbzhpfvyib (xmnritattr ) View more	-	07 Apr 2024
				Midazolam	mveetgaakx(ajzoortdbn) = kpquejbaus pbzhpfvyib (xmnritattr ) View more
NCT05480488 (Pubmed) Manual	Phase 1	-	18	midazolam 2 mg + warfarin 25 mg (period 1)	(mfyiwvgjzx) = lltkcxnbxs ashgmkdlak (gunzgnobfe ) View more	Positive	13 Mar 2024
				daridorexant 50 mg + midazolam 2 mg + warfarin 25 mg (period 2)	(mfyiwvgjzx) = qyyytowptk ashgmkdlak (gunzgnobfe ) View more
ESC2024	Not Applicable	Out-Of-Hospital Cardiac Arrest	-	Midazolam	(fpzytqiapy) = atqvttbmsl gussmeszht (vulsgcmacv )	-	08 Mar 2024
				No Midazolam	(fpzytqiapy) = niunqxujln gussmeszht (vulsgcmacv )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis