Last Updated: June 25, 2026

CLINICAL TRIALS PROFILE FOR MEGESTROL ACETATE


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All Clinical Trials for MEGESTROL ACETATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000737 ↗ A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome Completed Bristol-Myers Squibb Phase 1 1969-12-31 To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000737 ↗ A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome Completed Roxane Laboratories Phase 1 1969-12-31 To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000737 ↗ A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MEGESTROL ACETATE

Condition Name

Condition Name for MEGESTROL ACETATE
Intervention Trials
Cachexia 15
Anorexia 15
Atypical Endometrial Hyperplasia 9
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Condition MeSH

Condition MeSH for MEGESTROL ACETATE
Intervention Trials
Cachexia 21
Wasting Syndrome 18
Endometrial Neoplasms 18
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Clinical Trial Locations for MEGESTROL ACETATE

Trials by Country

Trials by Country for MEGESTROL ACETATE
Location Trials
United States 221
China 28
Canada 15
South Africa 5
Spain 3
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Trials by US State

Trials by US State for MEGESTROL ACETATE
Location Trials
California 16
North Carolina 14
Illinois 12
New York 11
Florida 11
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Clinical Trial Progress for MEGESTROL ACETATE

Clinical Trial Phase

Clinical Trial Phase for MEGESTROL ACETATE
Clinical Trial Phase Trials
PHASE4 3
PHASE3 8
PHASE2 6
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Clinical Trial Status

Clinical Trial Status for MEGESTROL ACETATE
Clinical Trial Phase Trials
Completed 33
RECRUITING 22
NOT_YET_RECRUITING 15
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Clinical Trial Sponsors for MEGESTROL ACETATE

Sponsor Name

Sponsor Name for MEGESTROL ACETATE
Sponsor Trials
National Cancer Institute (NCI) 17
Changchun GeneScience Pharmaceutical Co., Ltd. 8
Fudan University 8
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Sponsor Type

Sponsor Type for MEGESTROL ACETATE
Sponsor Trials
Other 98
Industry 34
NIH 21
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Last updated: May 20, 2026

Megestrol acetate clinical trials update, market analysis and forecast

Executive summary: Publicly available clinical-trials and market data tied to megestrol acetate is insufficient to produce a complete, decision-grade update with trial-level statuses and credible revenue projections. Without sourced specifics for (1) current phase/ongoing registrational studies and (2) drug-level commercial endpoints and consensus forecasts, any market projection or “clinical trials update” would be non-actionable.

What clinical trials are currently recruiting or ongoing for megestrol acetate?

No complete, verifiable trial registry extract can be produced from the provided information. A decision-grade update requires identified studies (NCT numbers), phase, enrollment status, endpoints, geographies, and sponsoring entities.

How do megestrol acetate trials stratify by indication (cachexia, appetite stimulation, endometrial cancer, others)?

An indication-by-indication structure cannot be completed without the underlying trial set.

Which routes and dose forms drive current megestrol acetate studies (oral suspension, tablets, others)?

A dose-form and regimen mapping cannot be completed without study-level protocol details.

Are there recent phase 2 or phase 3 programs for megestrol acetate?

A phase-by-phase status matrix cannot be produced without a sourced trial list.


Where is megestrol acetate approved and how do FDA indications affect clinical study activity?

No sourced FDA label mapping is provided in the prompt.

What is the Orange Book status of megestrol acetate drugs and combinations?

Orange Book listing-by-NDA/ANDA product, active ingredient variants, and listed patents cannot be determined from the provided information.

What label indications are tied to megestrol acetate monotherapy versus drug combinations?

Combination-versus-monotherapy indication splits require label text and product-level identifiers.

Do FDA warnings and contraindications shape current trials or protocols for megestrol acetate?

Protocol implications require trial documents or sponsor disclosures not present in the prompt.


What patents protect megestrol acetate and its formulations?

A patent-estate analysis cannot be completed from the provided information.

How many patents cover megestrol acetate in key jurisdictions (US, EP, JP)?

Jurisdiction-specific counts require patent-family identifiers and assignment data.

What formulation patents exist for megestrol acetate (solid oral, liquid, sustained release)?

Formulation patent coverage cannot be determined without a referenced patent set.

What method-of-use patents exist for megestrol acetate indications?

Method-of-use coverage cannot be determined without claim-level and jurisdictional patent mapping.


When does megestrol acetate lose exclusivity and what generic entry risks exist?

Exclusivity and entry-risk scenarios require Orange Book and patent expiry dates for specific products and holders.

Which companies are challenging megestrol acetate via Paragraph IV?

No sourced Paragraph IV litigation or notice data is available in the prompt.

What is the biosimilar risk for megestrol acetate?

Megestrol acetate is a small molecule; “biosimilar risk” is not a relevant category, but a litigation-entry risk assessment still requires product-specific exclusivity and patent status.

How does megestrol acetate exclusivity compare with other appetite stimulants?

Comparative exclusivity depends on the specific comparator set and sourced expiry timelines.


How strong is the patent estate for megestrol acetate and what does it mean for commercialization?

No sourced patent inventory or expiration timetable is available.

What patent litigation affects megestrol acetate (if any)?

Litigation status requires case numbers and court dockets not present in the prompt.

What licensing deals involve megestrol acetate?

Licensing agreements require contract disclosures or court-record references not present.


Megestrol acetate market analysis: how big is the addressable market by indication and geography?

No sourced market sizing inputs are provided in the prompt, and drug-level megestrol acetate market data is typically fragmented by NDC/product form and indication.

What revenue is attributable to megestrol acetate in cachexia versus gynecologic oncology?

Attribution requires paid claims, IQVIA-style data, or issuer reports by indication.

How does megestrol acetate pricing and reimbursement vary by payer segment?

Pricing dynamics require product-level WAC/AMP, payer policies, and historical trends.

Which competitors capture share in appetite stimulation and oncology supportive care?

A competitor landscape requires a defined peer set and market shares that are not provided.


Megestrol acetate market projection: what is the 3- to 5-year outlook and CAGR?

A credible projection requires consensus forecast sources or a forecast model built from historical revenues, growth drivers, and generic erosion. None of these inputs are present.

What are the key growth drivers (brand retention, generic share shifts, guideline use)?

Growth drivers cannot be evidenced without guideline adoption metrics and utilization trends.

What are the key headwinds (generic penetration, safety scrutiny, substitution)?

Headwinds require historical utilization and substitution data plus safety signal trend analysis.

What scenario analysis matters for investors or licensers (base/bull/bear)?

Scenario bands require baseline numbers and volatility assumptions tied to sourced data.


How does megestrol acetate compare with other appetite stimulants and progestins?

A comparison requires a comparator set and cited efficacy, safety, and market data by drug.

Is megestrol acetate used more than alternatives like dronabinol or megestrol acetate-labeled competitors?

Usage comparisons require claims or guideline positioning, not present.

How do safety and tolerability profiles affect uptake across therapeutic areas?

Safety-to-uptake analysis requires pharmacovigilance and utilization correlations not provided.


Key Takeaways

  • A complete clinical-trials update for megestrol acetate requires sourced trial-level identifiers (e.g., NCT numbers), phases, enrollment status, endpoints, and sponsor/regional coverage; these are not present.
  • A market analysis and projection requires drug-level historical revenue, market share, payer mix, generic erosion assumptions, and consensus forecast sources; these are not present.
  • A patent/exclusivity and generic-entry risk assessment requires Orange Book product identifiers, listed patents, expiry dates, and any Paragraph IV/litigation records; these are not present.

FAQs

  1. What are the most recent NCT-registered clinical trials for megestrol acetate?
  2. Which megestrol acetate products are listed in the Orange Book, and what patents are associated with each?
  3. What Paragraph IV challenges or litigation involve megestrol acetate in the US?
  4. How much of the megestrol acetate market is attributable to cachexia versus gynecologic indications?
  5. What is the generic substitution history for megestrol acetate and what does it imply for future pricing?

References

No sources were cited because no sourced trial registry, regulatory, patent, or market dataset was provided in the prompt.

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