CLINICAL TRIALS PROFILE FOR VERSED

505(b)(2) Clinical Trials for VERSED

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

All Clinical Trials for VERSED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00006070 ↗	Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2000-07-01	This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient discharged with Tylenol and codeine for pain. Visit 2: Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side. Visits 3 and 4: Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.
NCT00050180 ↗	Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2002-11-22	This study will examine whether a particular type of gene (MDR1) in the body can affect blood levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people with HIV. If blood levels of these drugs are too low or too high, they may not work well or may cause side effects in patients. This study will determine how MDR1 genes might affect absorption of these medicines. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates will be screened with a medical history and blood and urine tests. The blood will be tested for: - Routine laboratory values for assessing general health - HIV - MDR1 gene type - Amount of P-glycoprotein (a protein made by the MDR1 gene) on T cells. Participants will have blood drawn three more times, as follows: - After one dose of the sedative midazolam (Versed(Registered Trademark)): Participants will take an 8-milligram dose of midazolam syrup by mouth. Four hours later, a single blood sample will be drawn through a needle in an arm vein. This part of the study will assess the efficiency of a certain enzyme involved in metabolizing (breaking down) indinavir and saquinavir. - After four doses of indinavir: About a week after taking the midazolam, participants will take 800 mg of indinavir (two capsules) 3 times a day (every 8 hours) for 1 day. The following morning they will come to the clinic, where a catheter (flexible plastic tube) will be placed in an arm vein for repeated blood draws. A blood sample will be drawn, and a fourth and final dose of indinavir will be given. Seven blood samples of about a teaspoon each will then be collected through the catheter over an 8-hour period to measure blood levels of the drug. - After 10 doses of saquinavir: About a week after the last dose of indinavir, participants will start taking 1,200 mg (6 capsules) of saquinavir soft-gelatin capsules 3 times a day for 3 days. On the fourth day, participants will come to the clinic. A catheter will be inserted into an arm vein and about 4 teaspoons of blood will be collected for routine laboratory tests and to measure saquinavir levels. A urine sample will also be collected for routine tests. Participants will then receive the tenth and final dose of saquinavir, and eight blood samples of about a teaspoon each will be collected through the catheter over an 8-hour period.

Clinical Trial Conditions for VERSED

Condition Name

Condition Name for VERSED
Intervention	Trials
Pain	8
Anxiety	7
Critical Illness	5

Condition MeSH

Condition MeSH for VERSED
Intervention	Trials
Anxiety Disorders	7
Pain, Postoperative	6
Critical Illness	5

Clinical Trial Locations for VERSED

Trials by Country

Trials by Country for VERSED
Location	Trials
United States	131
Iran, Islamic Republic of	1
Canada	1
Netherlands	1
Japan	1

Trials by US State

Trials by US State for VERSED
Location	Trials
California	10
Pennsylvania	9
Ohio	8
Texas	8
Florida	8

Clinical Trial Progress for VERSED

Clinical Trial Phase

Clinical Trial Phase for VERSED
Clinical Trial Phase	Trials
Phase 4	36
Phase 3	11
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for VERSED
Clinical Trial Phase	Trials
Completed	64
Withdrawn	10
Terminated	10

Clinical Trial Sponsors for VERSED

Sponsor Name

Sponsor Name for VERSED
Sponsor	Trials
Yale University	5
Hospira, Inc.	4
Hospira, now a wholly owned subsidiary of Pfizer	4

Sponsor Type

Sponsor Type for VERSED
Sponsor	Trials
Other	106
Industry	32
NIH	12

Last updated: July 27, 2026

Versed (midazolam) clinical trials update, market analysis and price/projection

Versed is the U.S. brand of midazolam, a short-acting benzodiazepine used for procedural sedation, anesthesia induction, and anxiolysis. Midazolam’s market is mature, with pricing and share shaped primarily by hospital formularies, generic penetration in most dosage forms, and ongoing product-lifecycle management around injectable and oral/procedural variants.

Clinical trials update (high-level): No single late-stage midazolam “blockbuster” program can be confirmed from the available scope here. What remains investable is differentiation via delivery system, setting-specific labeling, and reformulation, not a new molecular entity.

Market analysis and projection (high-level): The market trajectory for midazolam (and Versed) is driven by (1) procedural volume trends (endoscopy, imaging, minor surgeries), (2) shift to outpatient settings, (3) generic substitution and contracting dynamics, and (4) supply and manufacturing consistency for injectable benzodiazepines.

What follows is constrained to the specific drug label ecosystem and midazolam’s established commercial positioning. No actionable clinical-trial readout or forward-looking numeric market forecast can be produced without verifiable program identifiers, endpoints, timelines, and sources for midazolam/Versed brand financials.

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What clinical trials are updating for Versed (midazolam) sedation and anesthesia?

Featured snippet answer: Midazolam development activity is primarily incremental (formulation, route optimization, and label-expansion) in a mature class, with no confirmed, globally dominant late-stage “Versed-specific” trial readout available in this scope.

Which midazolam trials matter commercially?

Commercially meaningful trial updates for midazolam typically target:

• Procedural sedation success rate (per protocol sedation end points)
• Time-to-sedation and time-to-discharge (workflow economics)
• Reversal and safety metrics (respiratory depression, hypotension, adverse events)
• Pediatric and perioperative subpopulations (weight-based dosing protocols)
• Delivery-system performance (onset and stability, administration ease)

Trial phase expectations for a mature benzodiazepine

In mature benzodiazepine franchises, late-stage programs most often:

• Reproduce efficacy under controlled conditions while improving practicality for ambulatory workflows
• Seek narrower or broader label language for specific procedural contexts
• Provide bridging data for new concentrations or device-assisted administration

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How big is the midazolam (Versed) market and what is the growth outlook?

Featured snippet answer: Midazolam’s growth is linked to procedure volumes and outpatient migration; branded growth is constrained by generic availability and contracting.

Key demand drivers

• Rising volume of endoscopy, GI procedures, and office-based interventions
• Growth of ambulatory surgery and shorter anesthesia episodes
• Increased imaging utilization (MRI/CT) where sedation is sometimes used
• Persistent reliance on benzodiazepines for anxiolysis and procedural sedation

Key headwinds

• Broad generic substitution, especially for injectable and commonly used strengths
• Hospital pharmacy contracting pressure (tendering and bulk purchasing)
• Substitution risk between benzodiazepines and comparator sedation strategies (propofol-based regimens, other sedatives)

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What is Versed’s pricing power under generic competition?

Featured snippet answer: Pricing power is limited and largely “formula-driven,” with net price set by hospital contracts and payer mix rather than clinical differentiation.

Price-setting mechanics in mature hospital injectables

• GPO and contract pricing compress margins for branded products once therapeutically interchangeable generics gain share
• Tender cycles can reallocate volume quickly between vendors
• Shortage dynamics can temporarily support pricing but rarely sustain long-term brand uplift

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When does Versed midazolam lose exclusivity by formulation or use?

Featured snippet answer: Midazolam’s molecular exclusivity has long expired; remaining exclusivity is typically tied to specific formulations, concentrations, or method-of-use claims.

What to map for exclusivity timelines

For midazolam/Versed, exclusivity analysis is usually broken into:

• Injectable formulation patents (specific salt forms, concentrations, stabilizers, or device formats)
• Orally administered variants (if applicable to the brand footprint in your market)
• Method-of-use or procedural indication patents
• Pediatric exclusivity or data exclusivity tied to label expansion (if any current programs apply)

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How many patents protect midazolam (Versed) formulations and methods of use?

Featured snippet answer: Patent estates for midazolam are fragmented and typically formulation- and presentation-specific rather than covering the underlying drug.

Patent estate structures to evaluate

• Composition-of-matter (rare for midazolam itself in modern markets)
• Formulation patents (buffering, solubilizers, stability, shelf-life)
• Process/manufacturing patents (sterility, impurity control, lyophilization steps if relevant)
• Method-of-use patents (dosing regimens, procedural settings, patient subgroups)

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What is the Orange Book status of Versed (midazolam) in the U.S.?

Featured snippet answer: Midazolam injectables generally show extensive generic presence, and Orange Book protections are typically presentation- and formulation-specific.

How Orange Book listings typically cluster for generics

• Multiple ANDA applicants for common strengths
• Carve-outs where a branded version retains specific formulation protection
• Label carve-outs tied to dosage regimen or route

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What Paragraph IV challenges exist for midazolam (Versed) products?

Featured snippet answer: No specific, currently actionable Paragraph IV challenge record can be stated in this scope without a mapped FDA/Orange Book ANDA data feed.

Where Paragraph IV matters

When it exists, Paragraph IV pressure typically comes from:

• Generic entry targeting the branded formulation’s remaining patent-protected attributes
• Litigation leverage around exclusivity windows and Orange Book-listed blocking patents
• Settlement agreements enabling early launch while carving out protected indications or presentations

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What patent litigation affects Versed midazolam generics and biosimilars risk?

Featured snippet answer: Midazolam is a small molecule, so biosimilar risk does not apply. Litigation, where present, is typically patent-infringement over formulation/process or method-of-use.

Litigation questions that drive launch timing

• Is the case about composition/formulation or about method-of-use?
• Are patents listed in the Orange Book tied to the marketed NDA presentation?
• Did a court grant a preliminary injunction or an agreement set launch date?

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How does Versed compare with other procedural sedatives for market share?

Featured snippet answer: Competitive displacement depends on clinical workflow and cost, not only efficacy. Midazolam competes with propofol-based sedation models, ketamine regimens in some settings, and alternative benzodiazepines where clinically equivalent.

Selection factors

• Monitoring requirements
• Recovery/discharge time
• Cost per procedure under hospital contracting
• Reversal and safety protocols used in each facility

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What generic entry risks exist for midazolam injectable and oral sedation products?

Featured snippet answer: Generic entry risk is persistent where branded formulations retain any remaining formulation/presentation protections that can be designed around.

Risk-map structure

• Launch risk rises when blocking patents expire or are narrowed
• Risk drops if patents are formulation-specific and generics cannot legally substitute
• Risk increases when settlement agreements give “at-risk” launch dates

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What manufacturing and IP barriers affect midazolam (Versed) supply?

Featured snippet answer: For injectables, the binding constraint is manufacturing reliability and quality compliance, with IP barriers relevant only to protected presentations.

Supply-chain levers

• Sterile manufacturing capacity
• Supplier qualification for excipients and active ingredient
• Batch impurity and stability performance
• Regulatory inspection history

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Market projection scenarios for midazolam (Versed): base, bull, bear

Featured snippet answer: Without brand-level financial baselines and identifiable trial and patent catalysts, only qualitative projections can be stated: base-case is steady procedural-volume-linked demand with net price pressure under generics; bull-case requires successful label/formulation differentiation or reversal of supply constraints; bear-case is accelerated contract compression and substitution.

Base case (most likely)

• Demand tracks procedural volumes and outpatient mix
• Net price declines in line with contracting and generic competition
• Incremental share shifts within sedation portfolios

Bull case

• Any protected presentation or formulation extension captures durable contracted volume
• Supply constraints elevate short-term pricing and reduce competitive undercutting

Bear case

• Faster contracting cycles and additional generic entrants for common presentations
• Substitution toward lower-cost regimens in key procedure settings

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Key Takeaways

• Versed (midazolam) operates in a mature, generic-dominant benzodiazepine market where growth is procedural-volume linked and margin is constrained by contracting.
• Clinical development in this class tends to be incremental, focused on delivery, workflow outcomes, and label expansion rather than new molecular breakthroughs.
• Exclusivity and IP value, where any remains, is typically formulation- and presentation-specific, so launch timing depends on Orange Book blocking patents and any associated litigation or settlements.
• Quantitative market projections and clinical trial timing cannot be produced here without a verifiable program/patent mapping input set and source-backed market baseline.

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FAQs

1. What midazolam formulations have the strongest remaining U.S. patent coverage?
2. How do outpatient procedural volumes affect midazolam sedation demand?
3. Which regulatory pathways apply to generic midazolam injectables in the U.S.?
4. What substitution patterns most often displace midazolam-based sedation in hospitals?
5. How do shortages and FDA enforcement actions impact midazolam pricing and availability?

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References (APA)

1. (No sources cited in this response.)