This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).

Start Date01 Jan 2099

Sponsor / Collaborator

Stanford University

NCT06736938 / Not yet recruitingPhase 4IIT

Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial

The goal of this clinical trial is to compare the safety and efficacy of two pharmacological sedation regimens during bronchoscopy procedures in adult patients who require elective bronchoscopy.
The main questions it aims to answer are:
* Is propofol/pethidine analgesia administered by a pulmonologist as effective and safe as midazolam/pethidine in achieving adequate sedation during bronchoscopy, particularly in terms of desaturation rate?
* Does the choice of sedative (midazolam vs. propofol) influence the occurrence of adverse events or need for escalated care?

Start Date01 Apr 2025

Sponsor / Collaborator-

NCT06330584 / RecruitingPhase 2

Administration of Intranasal Midazolam for Anxiety in Palliative Care - a Double-blind, Randomized, Placebo-controlled Multicenter Exploratory Pilot Study With a Nested Pharmacokinetic Analysis

The goal of this double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study (three study arms) is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients, while providing pharmacokinetic and pharmacodynamic data.

Start Date01 Jan 2025

Sponsor / Collaborator

Insel Gruppe AG

100 Clinical Results associated with Midazolam

100 Translational Medicine associated with Midazolam

100 Patents (Medical) associated with Midazolam

15,415

Literatures (Medical) associated with Midazolam

01 Apr 2025·DEN open

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

Article

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

Abstract:

Objectives:

To compare the efficacy and safety of sedation with midazolam and remimazolam for colorectal endoscopy.

Methods:

This 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.

Results:

Thirty‐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.

Conclusions:

Remimazolam yielded significantly faster times to awakening and discharge safely compared to midazolam.

01 Apr 2025·DEN open

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

Article

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

Abstract:

Objectives:

A 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.

Methods:

The 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.

Results:

There 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).

Conclusion:

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

Article

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

Abstract:

Objectives:

The effectiveness and safety of propofol‐based sedation and midazolam sedation in pediatric bidirectional endoscopy were compared.

Methods:

We 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.

Results:

Ninety‐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.

Conclusions:

Propofol‐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.

News (Medical) associated with Midazolam

10 Dec 2024

·www.echemi.com

Remarkable Sales Discrepancy of Remimazolam: $40 Million in China, Only $800,000 in the U.S.

In recent years, among the new anesthetic sedation drugs launched on the market, Remazolam has undoubtedly aroused widespread concern in the industry. The drug was designed and synthesized by GlaxoSmithKline (GSK) in 1999, and after several corporate transfers, it was approved for market in China, the United States, Europe and other countries and regions around 2020. However, there are significant differences in the market performance of remazolam across countries. According to 2023 data, the drug's sales in China are about $40 million, while in the United States it is only $800,000, accounting for only 2% of the Chinese market. The reasons for this difference are worth exploring in depth. Remazolam is an ultra-short-acting GABAA receptor agonist whose design is inspired by midazolam and remifentanil, combining the properties of both. It is rapidly metabolized by carboxylesterases in the liver to produce inactive metabolites, resulting in rapid sedation resolution and short sedation recovery time. Remazolam's development history dates back to 1999, when GSK designed and synthesized the drug based on remifentanil's properties and filed a patent application. The patent was then transferred to TheraSci in the United Kingdom. Paion began developing the drug in 2008. Due to the instability of remazolam's free base, Paion developed remazolam benzenesulfonate, while Hengrui Pharmaceuticals adopted remazolam in the form of (toluene sulfonate) salt. At present, these two salt types of remazolam have been listed, of which Remazolam toluene sulfonate is only listed in China, while Remazolam benzenesulfonate is listed in China, Japan, the United States, Europe and other countries, but there are differences in indications. In the Chinese market, RenFCM obtained the Chinese market rights of Remazolam besylate in 2012, and was approved by the State Food and Drug Administration for sedation in colonoscopy in 2020, followed by the induction and maintenance of general anesthesia and the indication of bronchoscopic sedation. In the United States, Remazolam besylate was approved in July 2020 under the trade name Byfavo for a 30-minute sedation procedure marketed by Eagle. Remazolam besylate is approved for induction and maintenance of general anesthesia in Japan and South Korea. It is worth noting that in the first quarter of 2024, Paion was acquired by China's Renfu Pharmaceutical, which means that the global interests of Remazolam besylate have been vested in Renfu Pharmaceutical. Remazolam toluene sulfonate was first approved for sale in China in 2019 for indications including induction and maintenance of general anesthesia and sedation during colonoscopy. The difference in sales in the U.S. and China markets may be related to the different range of indications approved for remazolam in different countries. In the United States, Remazolam is only approved for procedural sedation, while in China, its approved indications include general anesthesia and sedation, and sales are significantly higher than in the United States. In addition, the difference in sales performance between China and the United States may also be related to concerns about remazolam metabolites. Remazolam is metabolized in the body to produce methanol, which may be further oxidized to formaldehyde and formic acid, and formaldehyde is potentially cytotoxic. As a result, the FDA requires remazolam to be administered only within 0.5 hours to avoid the buildup of methanol and its metabolites to dangerous levels. At present, other anesthetic sedatives commonly used in clinical practice, such as propofol, benzodiazepines (represented by midazolam), and α-receptor agonists (represented by dexmetropil), all have their own shortcomings. Although Remazolam still has room for improvement in some aspects, its unique advantages, such as rapid onset, rapid metabolism, rapid sedation recovery, etc., make it a potential application value in the field of anesthesia sedation. With the advancement of medical technology and the in-depth exploration of clinical applications, there may be an improved version of remazolam in the future, bringing new options to the field of anesthesia sedation.

Drug ApprovalAcquisitionPatent ExpirationBiosimilar

20 Nov 2024

·www.businesswire.com

Melt Pharmaceuticals Reports Positive Phase 3 Topline Efficacy Results for MELT-300, Its Lead Product Candidate for Opioid-Free, Sublingual Procedural Sedation in Patients Undergoing Cataract Surgery

NASHVILLE, Tenn.--( BUSINESS WIRE )--Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced positive topline results of its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. Based on a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration (“FDA”) earlier this year, this study design and these positive results support the necessary objectives required for a regulatory submission. MELT-300 uniquely combines a fixed dose of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis ® delivery technology which dissolves in as little as 3 seconds allowing absorption of the active ingredients across the sublingual mucosa. The MELT-300 Phase 3 clinical trial was a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo, respectively, for procedural sedation in patients undergoing cataract surgery. The study was conducted at 13 clinical sites in the United States and enrolled over 530 patients. In commenting on the topline results, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, “We are extremely excited with this robust topline data from our pivotal Phase 3 study. These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids. With the number of cataract surgeries performed each year in the U.S. expected to exceed 5 million in the coming years, we believe offering patients and physicians the ability to achieve an adequate sedation level without the need to start an IV or administer opioids is a very attractive proposition.” MELT-300 co-inventor, Melt Pharmaceuticals board member, and board-certified ophthalmologist John Berdahl, M.D., commented, “A proprietary compounded combination of midazolam and ketamine, which was the inspiration for the development of the MELT-300 product candidate, has been used by hundreds of ophthalmologists, including myself – in hundreds of thousands of cataract surgeries. I am thrilled at the prospect of the FDA approving MELT-300, which I believe would greatly enhance the confidence of healthcare professionals in considering the adoption of this groundbreaking sedation method.” George Magrath, M.D., a board-certified ophthalmologist and a MELT-300 Phase 3 study principal investigator, commented, “These Phase 3 data show the superiority of the combination of midazolam and ketamine compared with midazolam alone. If approved, I believe MELT-300 will be a safe and effective alternative to current sedation methods used for cataract surgery. As an ophthalmologist, I am excited about the prospect of using MELT-300 to enhance the overall experience for my cataract surgery patients.” Dr. Dillaha continued, “In addition to supporting a regulatory submission, these MELT-300 Phase 3 data should further strengthen our already strong patent portfolio, both domestically and internationally. Further, with these data now confirming and complementing our robust Phase 2 efficacy and safety results, we believe we are well positioned to elevate the procedural sedation standard of care for cataract surgery and, through lifecycle management, eventually expand the potential use of MELT-300 to over 100 million annual procedures in various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care. “Melt Pharmaceuticals is profoundly grateful to the Phase 3 MELT-300 study participants, whose involvement has been invaluable. This includes the ophthalmologists, optometrists, anesthesiologists, certified registered nurse anesthetists, staff, and patients at the 13 U.S. clinical sites.” About Melt Pharmaceuticals Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-IV, non-opioid, sedation, and analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory approval through the FDA’s 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where possible. Melt’s core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com . Forward-Looking Statements This press release contains forward-looking statements, which are all statements other than those statements of historical facts. No representation or warranty is made as to such statements, all of which involve substantial risks and uncertainties. Actual results could vary materially.

Phase 3Clinical ResultPhase 2

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

100 Deals associated with Midazolam

External Link

KEGG	Wiki	ATC	Drug Bank
D00550	Midazolam	N05CD08	DB00683

R&D Status

Approved

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
Seizures	Phase 3	US	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	AU	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	AT	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	BE	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	CZ	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	DE	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	LT	UCB Biopharma SRL	01 Nov 2013
Seizures	Phase 3	ES	UCB Biopharma SRL	01 Nov 2013
Acute repetitive seizure	Phase 3	US	UCB Biopharma SRL	01 Jun 2011
Acute repetitive seizure	Phase 3	AU	UCB Biopharma SRL	01 Jun 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05126459 (CTgov)	Phase 3	Dental Caries	60	Meperidine+Hydroxyzine +Midazolam (Regimen 1)	zkfsdefleq(agdhfltovu) = sptkuposqv xqrrawnzud (frvlaeywon, yaoqyzxhws - nlqbawfbau) View more	-	02 Oct 2024
				Meperidine+Hydroxyzine (Regimen 2)	zkfsdefleq(agdhfltovu) = ttefwenuxz xqrrawnzud (frvlaeywon, iyunztodze - gorwwxkkhj) View more
NCT04051827 (CTgov)	Phase 1	Advanced Lung Non-Small Cell Carcinoma	26	Midazolam (Part A: Midazolam Alone)	osfxbigafi(pgtunnkmfa) = ixzgdvmmyl onogmdffea (dfnstmmfrm, dtutywijqv - vmmunuzsvu) View more	-	12 Apr 2024
				Midazolam+Mobocertinib (Part A: Midazolam + Mobocertinib)	osfxbigafi(pgtunnkmfa) = obujakplah onogmdffea (dfnstmmfrm, aaoekxlguu - rjnzdyttap) View more
NCT05480488 (Pubmed) Manual	Phase 1	-	18	midazolamant 50 mwarfarin	hrodozhltm(wrckdokurg) = vuzrxgzvqn akdsuxknlv (ydnlolghaf ) View more	Positive	13 Mar 2024
				daridorexantmgmidazolamwarfarin	hrodozhltm(wrckdokurg) = rdvvgmfyic akdsuxknlv (ydnlolghaf ) View more
ESC2024	Not Applicable	Out-Of-Hospital Cardiac Arrest	-	Midazolam	cciavztswn(lprmnfgusa) = cncmkxlxsu ttivpexepr (ifznhqrcad )	-	08 Mar 2024
				No Midazolam	cciavztswn(lprmnfgusa) = vlvignjwdl ttivpexepr (ifznhqrcad )
NCT03815344 (CTgov)	Phase 4	Leiomyoma	74	Standard-vaginal misoprostol (Standard)	afkdwgfhoh(vaenxzbttl) = bicjbobbdw cnbqsfticq (okyxwbzxpu, nhbdwxxrri - fwihfpqlyz) View more	-	09 Jan 2024
				Standard-vaginal misoprostol+Standard (Standard-Vaginal Misoprostol)	afkdwgfhoh(vaenxzbttl) = xpdqagxsxh cnbqsfticq (okyxwbzxpu, hgynxepobi - pqdwtfnbmx) View more
NCT04068948 (CTgov)	Phase 4	Sedation \| Dental Caries	37	Meperidine+Hydroxyzine+Midazolam (Midazolam, Hydroxyzine, Meperidine)	onnkwkojzp(vnzmixffcj) = qxwzwyngui kuwrxbwlpa (lfszektdna, xnswajbwgr - nukifpunic) View more	-	05 Dec 2023
				Hydroxyzine+Midazolam (Midazolam, Hydroxyzine)	onnkwkojzp(vnzmixffcj) = uozjpbjbdm kuwrxbwlpa (lfszektdna, gnvpoelchv - oqqkfrsqkc) View more
DDW2023	Not Applicable	-	-	Remimazolam	hxmpnsbvpf(hfziassgqt) = ofwkwmumkq cfsbozwsfx (cwfzuojnpx, 10.11) View more	-	09 May 2023
				Midazolam	hxmpnsbvpf(hfziassgqt) = yqfipmebhe cfsbozwsfx (cwfzuojnpx, 15.23) View more
NCT03420742 (CTgov)	Phase 1	Neoplasms \| ALK Positive Solid Tumors	24	Midazolam (Part A, Cycle 1 Day 1: Midazolam Alone)	ncvzbklcoa(uearxxdinh) = orswzoyexo rdxprbhhrk (etqoztnscc, ekczmnleiu - uzosdkgsdd) View more	-	27 Jan 2023
				Midazolam+Brigatinib (Part A, Cycle 1 Day 21: Midazolam + Brigatinib)	ncvzbklcoa(uearxxdinh) = cdhizkyxqs rdxprbhhrk (etqoztnscc, zdcmferjgu - roiuzshhez) View more
Pubmed	Phase 1	ALK Positive Solid Tumors	-	Brigatinib	ubqodpwkvy(zxdnqjprmq) = ndcwtumuvs rawharplzg (augqavnyym ) View more	-	29 Dec 2022

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