CLINICAL TRIALS PROFILE FOR MIDOL LIQUID GELS

505(b)(2) Clinical Trials for MIDOL LIQUID GELS

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	NCT00262145 ↗	Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption	Completed	NatureGen	Phase 1	2005-10-01	Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
New Dosage	NCT00858936 ↗	Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery	Terminated	Mallinckrodt	Phase 2	2009-05-01	This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during surgery. This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the study drug. There will be 6 different groups of 6 subjects each that will receive the study drug or a placebo. A placebo is a substance that will be prepared to look like the study drug but will contain no active ingredients. In Part 1, five subjects from each group will receive study drug (IK-1001) and one will receive a placebo. This first part of this study is also a dose (amount) escalation. This means that each group will be receiving a different dose of the study drug. The first group will receive the lowest dose, the second group will receive a slightly higher dose, and the third group a slightly higher dose until all six groups has been tested. You can not choose which group you will be in but prior to starting each new dose level, the data (information) from the previous dose level will have been reviewed by a group of qualified individuals to determine if it is safe to proceed to the next highest dose level. Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a dose level that has been deemed safe from information collected from Part 1. Subjects in Part 2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo. Whether the subject gets study drug or the placebo will be randomly assigned (like the toss of a coin). The study drug or placebo will be given as an intravenous infusion (into the vein) for six hours while the subject is having their CABG surgery. The subjects will be followed up for 6 months after their CABG surgery.
OTC	NCT00894634 ↗	Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2009-03-21	The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to
New Formulation	NCT01267201 ↗	A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form	Completed	Pfizer	Phase 1	2010-11-01	A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
New Dosage	NCT01323010 ↗	Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	N/A	2011-09-01	Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.

All Clinical Trials for MIDOL LIQUID GELS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000140 ↗	The Silicone Study	Completed	National Eye Institute (NEI)	Phase 3	1985-09-01	To compare, through a randomized, multicenter surgical trial, the postoperative tamponade effectiveness of intraocular silicone oil with that of an intraocular long-acting gas (initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy and associated techniques. To evaluate the ocular complications that result from the use of silicone oil and gas.
NCT00000302 ↗	Study Comparing Liquid and Tablet Buprenorphine Formulations - 5	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	1969-12-31	The purpose of this study is to compare liquid and tablet buprenorphine formulations.
NCT00000320 ↗	Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2	1997-10-01	The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
NCT00000341 ↗	Evaluation of Liquid vs. Tablet Buprenorphine - 6	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1996-08-01	The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.
NCT00000865 ↗	The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.

Clinical Trial Conditions for MIDOL LIQUID GELS

Condition Name

Condition Name for MIDOL LIQUID GELS
Intervention	Trials
Healthy	84
Healthy Volunteers	31
Breast Cancer	30
Obesity	26

Condition MeSH

Condition MeSH for MIDOL LIQUID GELS
Intervention	Trials
Diabetes Mellitus	53
Infections	46
Diabetes Mellitus, Type 2	40
Infection	40

Clinical Trial Locations for MIDOL LIQUID GELS

Trials by Country

Trials by Country for MIDOL LIQUID GELS
Location	Trials
Germany	96
Spain	86
France	81
Brazil	60
Australia	57

Trials by US State

Trials by US State for MIDOL LIQUID GELS
Location	Trials
California	177
Texas	149
New York	117
Ohio	105
Florida	105

Clinical Trial Progress for MIDOL LIQUID GELS

Clinical Trial Phase

Clinical Trial Phase for MIDOL LIQUID GELS
Clinical Trial Phase	Trials
PHASE4	26
PHASE3	17
PHASE2	43

Clinical Trial Status

Clinical Trial Status for MIDOL LIQUID GELS
Clinical Trial Phase	Trials
Completed	882
Recruiting	272
Not yet recruiting	141

Clinical Trial Sponsors for MIDOL LIQUID GELS

Sponsor Name

Sponsor Name for MIDOL LIQUID GELS
Sponsor	Trials
National Cancer Institute (NCI)	89
Bayer	28
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	28

Sponsor Type

Sponsor Type for MIDOL LIQUID GELS
Sponsor	Trials
Other	1889
Industry	762
NIH	228

Clinical Trials Update, Market Analysis, and Projection for Midol Liquid Gels (Acetaminophen, Pyrilamine Maleate, Caffeine)

Last updated: July 30, 2026

Midol Liquid Gels is an OTC combination analgesic-antihistamine-stimulant product (typically acetaminophen plus pyrilamine maleate plus caffeine) marketed for menstrual discomfort. Because it is an OTC medicine, it is generally not subject to the FDA’s prescription-drug clinical-trial disclosure regime (e.g., NDAs/BLAs, Orange Book exclusivity, patent certifications, Paragraph IV). There is also no single, authoritative “drug development pipeline” dataset comparable to prescription products. As a result, the most decision-relevant market view is based on OTC category demand, competitive pricing, channel movement, and retailer-level assortment changes rather than IND/NDA milestones.

What clinical trials exist for Midol Liquid Gels, and what do the results show?

Featured answer: There is no routine public “clinical trial update” workflow for Midol Liquid Gels comparable to prescription drugs because the product is OTC. Public clinical evidence, where available, typically relates to the individual active ingredients and older combination labeling rather than new post-approval pivotal studies.

What study types typically apply to OTC combination menstrual products?

OTC combination analgesic products in this category usually rely on:

• Existing monograph or historical labeling for safety and effectiveness of each active ingredient.
• Bioavailability or formulation-appropriate comparability work when reformulating (for example, capsule or gel-cap changes, taste-masking, or dissolution changes).
• Post-marketing observational studies are uncommon in publicly searchable registries for OTC brands.

Where would “modern trials” most likely show up?

When companies run new studies for OTC products, they are most likely to appear as:

• FDA OTC monograph-related submissions and manufacturing supplement filings (not consistently reflected in public trial registries).
• Small-scale formulation, palatability, or pharmacokinetic bridging studies, often not tied to a drug “approval timeline.”

Clinical-trial disclosure bottom line: A “trial update” for Midol Liquid Gels is not realistically deliverable from the public regulatory and registry record in the same way as a prescription program.

What market share, sales trends, and demand drivers matter for Midol Liquid Gels?

Featured answer: Midol’s topline OTC demand is driven by period-discomfort cycles, retail promo intensity, and competitive substitution within analgesic and menstrual-specific OTC aisles. Market share is shaped more by distribution and pack-price than by clinical differentiation.

Demand drivers for menstrual OTC analgesics

• Seasonality tied to menstrual cycle purchasing patterns and summer versus fall retail cadence.
• Promotional frequency in drugstore and mass channels.
• Substitution pressure from other OTC options (NSAIDs where permitted, acetaminophen-only, and competing “menstrual relief” brand lines).
• Pack format: liquid gels often target convenience and perceived faster onset versus standard tablets/capsules.

Channel dynamics

For OTC pain/menstrual products, the biggest swing factors are:

• Assortment expansion or delisting by major retailers (drugstores and mass merchandisers).
• Private label competitive pricing in pain and analgesic segments.
• Online channel availability and bundled multipacks.

Competitive landscape to watch

Key competitive clusters for a Midol liquid-gels positioned product:

• Other Midol formats (different dosing strengths or delivery systems, often competing within the same brand).
• Competing menstrual relief OTC brands with acetaminophen and antihistamine/caffeine combinations.
• Acetaminophen-only products sold under broad pain relief branding that can substitute for menstrual discomfort.
• NSAID-based OTC options where consumers perceive better efficacy for cramps.

How big is the OTC menstrual discomfort analgesic category, and where does Midol Liquid Gels fit?

Featured answer: Midol Liquid Gels sits in the broader OTC pain relief and menstrual discomfort categories, and its growth tracks category volume plus share shift versus alternative actives and brand formats.

Segmentation that matters commercially

Most buyers allocate OTC shelf space by:

• Active ingredient class (acetaminophen, NSAID, combination).
• Indication framing (menstrual cramps, pain, headache, “PM” versus day).
• Pack format (tablets, caplets, liquid gels, dual-action products).

Midol liquid gels compete primarily as:

• A menstrual discomfort, acetaminophen-based combination format
• A convenience-format SKU that competes for trial purchases.

What metrics typically best predict Midol-format movement?

• Retail dollar sales and unit velocity by pack size.
• Average net price after promotions.
• Share of wallet within “menstrual relief” shelf segments.
• Online review volume and ratings for perceived onset and tolerability.

When will Midol Liquid Gels face regulatory or exclusivity changes?

Featured answer: Midol Liquid Gels is an OTC product and does not operate on the same exclusivity framework as prescription drugs, where FDA exclusivity and patent “lose dates” drive Paragraph IV and generic entry.

What “exclusivity” concept applies to OTC?

For OTC medicines, exclusivity can map more to:

• Marketing authorizations under OTC regulatory pathways (including monograph frameworks where applicable).
• Trademark and trade dress protection.
• Manufacturing method control and formulation differentiation (more often at the commercial level than at the FDA exclusivity level).

What “regulatory risk” would be most relevant?

Regulatory risk for OTC products tends to come from:

• Labeling updates reflecting post-marketing safety communications.
• Reformulation and manufacturing quality changes that require supplements or changes in labeling.

Regulatory bottom line: There is no patent/exclusivity timeline that can be mapped to “midol liquid gels” in the same way as a prescription drug.

What is the likely 5-year sales projection for Midol Liquid Gels, and what scenario range fits?

Featured answer: A defensible numeric 5-year projection is not possible here without quantified baseline category sales, Midol brand share by channel, and SKU-level data. For OTC products, even small changes in retailer distribution or promo calendars can move unit volumes materially.

Practical projection framework for OTC menstrual analgesics

Without SKU-level starting points, projections should be modeled as:

• Category growth (CAGR for OTC menstrual relief or OTC analgesics overall)
• Share change (Midol format versus other brands and private label)
• Price/mix (promotion intensity, pack sizes, and format substitution)
• Distribution change (listing wins/losses)
• Velocity sensitivity (units per week)

Scenario structure (what drives upside/downside)

Upside drivers:

• Improved retail distribution for the liquid-gels format.
• Higher net price sustained with reduced promotion.
• Share gains versus competing formats perceived as less convenient.

Downside drivers:

• Private label pricing pressure and increased promo cadence.
• Share shift from liquid gels to caplets/tablets or to alternative actives.
• Delisting or reduced shelf allocation.

How does Midol Liquid Gels compare with other OTC menstrual pain products on differentiation?

Featured answer: Differentiation is mainly format and consumer positioning rather than a clinically distinct mechanism that would produce new evidence waves.

Comparison dimensions that matter for buy-side decisions

• Onset perception: liquid gels can be positioned as faster acting than standard forms.
• Ingredient positioning: acetaminophen-based versus NSAID-based offerings.
• Tolerability perception: antihistamine/caffeine combinations are often judged by sedation or stimulation profile.
• Convenience: ease of use and swallowing experience.

What rivals are likely to steal share?

• “Menstrual” products that bundle perceived faster relief.
• Acetaminophen-only products under large mass brands with lower price.
• Private label pain relief products with aggressive price points.

What patent estate protects Midol Liquid Gels, and is there patent litigation risk?

Featured answer: Midol Liquid Gels is not a prescription product with an Orange Book patent list tied to an NDA/BLA. Patent estates in this space are typically about:

• Formulation or composition patents (where pursued)
• Process patents (manufacturing)
• Trademark and brand protection
• When applicable, dosage form patents

Patent litigation risk tied to FDA generic entry (Paragraph IV) is generally not the governing model for OTC products.

Key Takeaways

• Midol Liquid Gels is an OTC menstrual discomfort analgesic combination. Public “clinical trials updates” comparable to prescription development programs are not available as a structured timeline.
• Market performance depends on OTC category demand, retailer distribution, pack format substitution, and promotion intensity.
• An exact 5-year numeric sales projection cannot be produced without SKU and channel baseline inputs; the most actionable approach is scenario modeling using category growth, share shift, price/mix, and distribution changes.
• Exclusivity and patent-driven generic entry frameworks used for prescription drugs generally do not map cleanly to OTC Midol Liquid Gels.

FAQs

1. Is Midol Liquid Gels approved under an NDA or covered by FDA Orange Book listings?
2. What active ingredients are in Midol Liquid Gels, and how do those ingredients map to OTC safety and labeling frameworks?
3. How does liquid-gel formulation affect consumer perceptions of onset versus tablets or caplets in OTC menstrual relief?
4. Which retailer channels are most important for Midol format sales: drugstore, mass, or online?
5. What types of reformulation or manufacturing changes can trigger OTC labeling or submission activity for Midol brands?

References

1. FDA. OTC Drug Products: Questions and Answers. U.S. Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. Search results for OTC combination analgesics and menstrual discomfort indications. U.S. National Library of Medicine.