Last Updated: April 30, 2026

CLINICAL TRIALS PROFILE FOR MEGACE


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All Clinical Trials for Megace

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002345 ↗ The Safety and Effectiveness of Megace in HIV-Infected Women Completed Bristol-Myers Squibb Phase 4 1969-12-31 To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24 weeks.
NCT00031707 ↗ Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite Completed National Cancer Institute (NCI) Phase 3 2000-03-01 RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
NCT00031707 ↗ Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite Completed NCIC Clinical Trials Group Phase 3 2000-03-01 RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
NCT00031707 ↗ Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite Completed Alliance for Clinical Trials in Oncology Phase 3 2000-03-01 RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
NCT00066248 ↗ Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment Completed National Cancer Institute (NCI) Phase 2 2003-06-01 RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Megace

Condition Name

Condition Name for Megace
Intervention Trials
Anorexia 6
Cachexia 6
Atypical Endometrial Hyperplasia 5
Endometrial Carcinoma 4
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Condition MeSH

Condition MeSH for Megace
Intervention Trials
Endometrial Neoplasms 9
Hyperplasia 8
Endometrial Hyperplasia 7
Cachexia 7
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Clinical Trial Locations for Megace

Trials by Country

Trials by Country for Megace
Location Trials
United States 112
Canada 12
South Korea 6
South Africa 5
Korea, Republic of 4
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Trials by US State

Trials by US State for Megace
Location Trials
California 7
North Carolina 6
Pennsylvania 6
Missouri 5
Ohio 5
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Clinical Trial Progress for Megace

Clinical Trial Phase

Clinical Trial Phase for Megace
Clinical Trial Phase Trials
PHASE2 1
Phase 4 3
Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Megace
Clinical Trial Phase Trials
Completed 19
Recruiting 5
Withdrawn 4
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Clinical Trial Sponsors for Megace

Sponsor Name

Sponsor Name for Megace
Sponsor Trials
National Cancer Institute (NCI) 10
Asan Medical Center 4
Fudan University 2
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Sponsor Type

Sponsor Type for Megace
Sponsor Trials
Other 46
Industry 14
NIH 10
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Megace Market Analysis and Financial Projection

Last updated: April 28, 2026

Megace (megestrol acetate): Clinical-trial status, market analysis, and forward projection

What is Megace and what indication set drives current demand?

Megace is the brand name for megestrol acetate, a synthetic progestin. In practice, commercial supply and demand are tied to its established roles in cancer-related wasting/weight loss and cachexia syndromes, with the majority of historic and ongoing use anchored in oncology supportive care. The core commercial story is single-ingredient, long-established therapy with limited competitive entry relative to modern oncology drug classes.

Formulations and routes (label-driven commercial use)

  • Oral suspension/tablets (most common patient-facing formats in mature markets)
  • Use patterns depend on country labeling, reimbursement criteria, and supportive-care protocols.

What does the clinical-trials landscape look like for Megace?

Megestrol acetate has a long clinical history and limited novelty-driven pipeline activity compared with oncology therapeutics. Current activity is typically concentrated in:

  • Supportive-care endpoints (appetite, weight gain, symptom burden)
  • Combination regimens (less frequent than in novel drug classes)
  • Post-marketing or small comparative studies rather than large registrational programs

A practical way to assess “clinical-trials update” for Megace is to distinguish between: 1) Interventional studies seeking to formalize a supportive-care claim in defined populations
2) Observational or real-world work focused on outcomes, tolerability, or dosing practices

At the current stage of the product lifecycle, new registration-quality programs are sparse. The commercial impact comes more from guideline adherence, formulary placement, and payer coverage than from rapid clinical “wins.”

Clinical development reality check (investment lens)

  • Megestrol acetate’s evidence base is mature.
  • Trial additions rarely change competitive dynamics unless they trigger major guideline or payer shifts.
  • The product’s growth is primarily a function of supportive-care incidence and prescribing behavior, not breakthrough trial readouts.

What is the market structure for Megace?

The megestrol acetate market is a mature, branded-plus-generic category in many jurisdictions. Megace competes across:

  • Therapy substitutes for appetite stimulation and weight stabilization
  • Alternative supportive-care agents used in similar clinical contexts

Key demand drivers

  • Prevalence of cancer-related weight loss and cachexia syndromes
  • Patient adherence and clinician preference for oral supportive therapies
  • Reimbursement and inclusion in supportive-care pathways
  • Safety profile management (notably known progestin-associated risks)

Key constraints

  • Aging evidence maturity limits “brand lift” versus newer agents
  • Any payer tightening around oncology supportive care reduces volume
  • Side-effect burden can shift prescribing to alternatives

What is the competitive set and how does it affect pricing power?

Megestrol acetate faces competition from agents and strategies used for appetite/weight outcomes, including:

  • Other appetite stimulants used in cachexia settings
  • Oncology supportive regimens that reduce functional decline without relying on progestins

Because Megace is mature and generic availability is common, pricing power is structurally limited. Competitive pressure tends to show up as:

  • Share erosion in markets with broad generic penetration
  • Formulary restrictions in some payer segments
  • Substitution when clinicians prefer a different mechanism or improved tolerability

How should a business forecast be built for Megace?

A credible projection for Megace must use a demand framework aligned to supportive-care epidemiology and prescribing rather than oncology launch curves. The forecasting logic is:

1) Population base

  • Patients with underlying malignancies and supportive-care needs that map to weight loss/appetite interventions 2) Penetration rate
  • Proportion receiving megestrol acetate versus substitutes 3) Dose intensity and persistence
  • Typical duration of use, switching rates, and discontinuation drivers 4) Coverage and price
  • Branded vs generic mix, net price trends, and payer edits 5) Safety-event handling
  • Clinician behavior adjustment after adverse-event experiences or safety communications

Forward-looking view

  • Megace is expected to remain a steady, maintenance-growth product in markets where supportive care demand remains stable to slightly increasing.
  • Growth is more likely to come from volume stabilization and pricing normalization than from a surge in clinical adoption.

Market projection (scenario framework)

The absence of fresh, large-scale registrational trial breakthroughs means projections should be anchored to macro and access rather than clinical switching. A business-grade approach is to model three scenarios:

Scenario Volume driver Price/net revenue driver Outcome profile
Base case Stable supportive-care penetration Gradual net price pressure from generics and payer leverage Low single-digit CAGR profile
Downside Payer tightening and increased substitution Larger net price declines Flat-to-decline revenue
Upside Stable/strong clinician preference and coverage Less aggressive net price erosion Low-to-mid single-digit growth

Projection direction (qualitative)

  • Expect limited upside because the competitive set is established and brand switching incentives are modest.
  • Expect continued erosion risk where generic penetration is high and reimbursement is restrictive.

What is the likely commercialization “watch list” for Megace?

For an investor or R&D decision-maker, the practical watch list is not trial novelty, but operational and policy variables:

  • Guideline and formulary updates affecting supportive-care use
  • Payer prior authorization patterns in oncology supportive settings
  • Safety communications that alter prescribing habits
  • Supply continuity and manufacturing economics for the branded product (where relevant)

What can be concluded about clinical-trial impact on revenue?

Megestrol acetate’s clinical-trial additions (when they occur) tend to:

  • Reinforce label-consistent use
  • Update dosing tolerance data
  • Provide real-world utilization evidence

They rarely re-anchor treatment practice at a scale that changes the long-run revenue trajectory unless:

  • A trial produces a strong differentiating outcome that payers incorporate into coverage criteria, or
  • Safety data drive a shift away from competing agents toward progestins

Key Takeaways

  • Megace (megestrol acetate) is a mature supportive-care product; clinical trial momentum is typically incremental rather than registrationally transformative.
  • The commercial market is structurally constrained by generic competition and payers’ management of oncology supportive care, limiting sustained pricing power.
  • Forward projections should be built on supportive-care epidemiology, penetration, persistence, and net price, not on drug-launch dynamics.
  • Near- to mid-term outcomes most likely map to a base-case low single-digit revenue growth band, with downside tied to payer tightening and substitution and upside tied to coverage stability.

FAQs

1) Is Megace still actively used in oncology supportive care?
Yes. Use remains tied to appetite/weight and cachexia-related supportive-care practice patterns in oncology, with utilization governed largely by payer coverage and clinician protocols.

2) Will new trials likely change Megace’s market position?
Not often. The evidence base is mature; most incremental studies do not materially change competitive dynamics unless payers and guidelines incorporate them into coverage rules.

3) How does generic competition affect Megace revenue?
It typically compresses net pricing and shifts demand toward lower-cost options in markets with broad generic access, reducing branded share.

4) What safety issues matter most for prescribing behavior?
Clinicians manage known progestin-associated risks, and safety experience can influence switching to alternative supportive-care therapies when risk tolerance changes.

5) What is the best metric for tracking Megace demand over time?
Monitor supportive-care utilization proxies tied to oncology weight loss/cachexia treatment, plus net price and formulary inclusion dynamics rather than relying on headline trial results.


References

  1. Drugs@FDA. Megace (megestrol acetate). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
  2. National Library of Medicine. Megestrol acetate clinical trial records (clinicaltrials.gov listing). ClinicalTrials.gov. https://clinicaltrials.gov/

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