Last Updated: May 2, 2026

CLINICAL TRIALS PROFILE FOR ACTONEL


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Actonel

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
New Formulation NCT00632216 ↗ A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis Completed Sanofi Phase 4 2004-05-01 The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Actonel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00051636 ↗ Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period Completed Novartis Pharmaceuticals Phase 3 2001-01-01 The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.
NCT00054418 ↗ Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer Completed National Cancer Institute (NCI) Phase 3 2003-03-01 RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
NCT00054418 ↗ Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer Completed Alliance for Clinical Trials in Oncology Phase 3 2003-03-01 RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Actonel

Condition Name

Condition Name for Actonel
Intervention Trials
Osteoporosis 12
Osteoporosis, Postmenopausal 5
Bone Loss 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Actonel
Intervention Trials
Osteoporosis 19
Osteoporosis, Postmenopausal 7
Bone Diseases, Metabolic 4
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Actonel

Trials by Country

Trials by Country for Actonel
Location Trials
United States 72
Canada 13
Australia 5
United Kingdom 4
Spain 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Actonel
Location Trials
North Carolina 5
Pennsylvania 4
Ohio 4
New York 4
Massachusetts 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Actonel

Clinical Trial Phase

Clinical Trial Phase for Actonel
Clinical Trial Phase Trials
Phase 4 16
Phase 3 12
Phase 2/Phase 3 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Actonel
Clinical Trial Phase Trials
Completed 27
Unknown status 3
Not yet recruiting 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Actonel

Sponsor Name

Sponsor Name for Actonel
Sponsor Trials
Sanofi 10
Procter and Gamble 9
University of Pittsburgh 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Actonel
Sponsor Trials
Other 32
Industry 27
NIH 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Actonel Market Analysis and Financial Projection

Last updated: April 28, 2026

ACTONEL (risedronate): Clinical Trials Update, Market Analysis, and Projection

What is ACTONEL’s clinical-trials status and what evidence supports current use?

ACTONEL is the brand name for risedronate (commonly risedronate sodium) used for osteoporosis and related bone disorders. The clinical program for risedronate is mature; the brand’s current clinical relevance in practice is driven by established efficacy and long-term safety from earlier registrational and post-marketing studies, rather than a steady pipeline of novel late-stage trials under the ACTONEL brand.

Trial landscape (how the evidence base is typically structured for ACTONEL/risedronate)

Because ACTONEL is an established bisphosphonate with widely distributed generics, most new clinical activity in recent years tends to fall into these buckets:

  • Label refinement (new populations, persistence adherence sub-analyses, or comparative adherence endpoints versus other bone therapies).
  • Switch studies and bioequivalence/PK bridging for generic entrants (not typically “brand-sponsored” new efficacy trials).
  • Real-world evidence and claims-based analyses rather than pivotal Phase 3 filings.

Practical implication for investors and R&D

For ACTONEL as a therapy line, the value driver is not new clinical endpoints from a late-stage ACTONEL-sponsored program. The value driver is:

  • ongoing prescribing where risedronate retains guideline fit,
  • adherence profiles versus alternatives,
  • payer and formulary positioning amid generic penetration,
  • safety perception and persistence in older osteoporosis cohorts.

Where does ACTONEL sit in the osteoporosis market and how is demand shaped?

ACTONEL competes in a defined therapeutic category: osteoporosis treatment (primarily postmenopausal). The commercial landscape is shaped by:

  • generic bisphosphonates (broad price competition),
  • alternative mechanisms with higher uptake in some geographies (anti-RANKL, anabolic therapy, and anti-sclerostin in select patients),
  • payer-driven step therapy.

Competitive set

ACTONEL’s direct competitive pressure typically comes from:

  • other oral bisphosphonates (alendronate, ibandronate),
  • injectable bisphosphonates (zoledronic acid),
  • newer non-bisphosphonate options in premium segments (denosumab, teriparatide/abaloparatide, romosozumab),
  • adherence-linked competitors (less frequent dosing schedules).

Market-shaping factors for ACTONEL

Demand is materially influenced by:

  • price compression from generic entry,
  • dosing convenience and persistence (oral schedule tolerability),
  • renal safety labeling boundaries (as a drug class, bisphosphonates face renal-function constraints),
  • sequence of therapy (patients move between classes based on prior fracture, persistence, and cost).

What is the market outlook for ACTONEL through the next planning horizon?

With ACTONEL as an older bisphosphonate brand, the projection is driven less by incremental clinical differentiation and more by:

  • the remaining prescribing share in older cohorts,
  • guideline adherence and prescriber familiarity,
  • generic market dynamics and formulary contracting,
  • substitution by newer mechanisms for higher-risk populations.

Projection framework (what moves revenue for ACTONEL-like products)

A realistic revenue trajectory in mature osteoporosis categories typically follows:

  • continued share erosion as newer agents penetrate higher-risk lines,
  • partial stabilization where oral bisphosphonates are preferred as first-line due to cost,
  • volatility from tendering and payer switch programs,
  • persistence-based effects where dosing tolerance changes real-world discontinuation rates.

Base-case direction (high level)

  • Units: gradual decline in share vs. non-bisphosphonates in higher-risk cohorts; oral bisphosphonate volume may remain durable where cost-focused formularies dominate.
  • Value (revenue): tends to compress faster than units due to generic pricing and contract rebates.
  • Profit pool position: shifts from “brand margin” to “generic-like margin” economics over time unless a protected formulation or differentiated access emerges.

How should R&D and investment decisions be framed for ACTONEL?

ACTONEL’s most investable paths, when pursued by sponsors or co-developers, generally align with:

  • reformulation with improved tolerability or reduced dosing burden (if any non-generic protected IP exists),
  • adherence-persistence programs tied to payer outcomes,
  • lifecycle management that targets specific segments where oral therapy maintains guideline fit.

Without a protected late-stage program, the investment case relies on:

  • distribution economics,
  • payer access and contracting,
  • patient persistence and discontinuation drivers,
  • and the ability to defend share against injectable and newer mechanisms.

Key Takeaways

  1. ACTONEL is a mature risedronate franchise; the current clinical story is anchored in established evidence rather than a fresh late-stage ACTONEL pipeline.
  2. Market demand is governed mainly by generic price dynamics, formulary access, and persistence rather than new clinical differentiation.
  3. The outlook through the next planning horizon is share pressure from newer osteoporosis mechanisms, with partial stabilization where oral cost-focused pathways remain dominant.
  4. The most actionable decision levers are contracting, patient persistence support, and any differentiated product protection (if available) rather than new registrational efficacy development.

FAQs

  1. Is ACTONEL currently in late-stage clinical trials?
    ACTONEL/risedronate has a mature clinical evidence base; new pivotal late-stage trials under the ACTONEL brand are not the dominant market driver for this franchise.

  2. What is ACTONEL’s competitive position versus denosumab or anabolic agents?
    ACTONEL faces share pressure in higher-risk segments where anti-RANKL and anabolic therapies gain uptake, but it can remain durable where oral bisphosphonates are preferred on cost and guideline fit.

  3. How does generic competition affect ACTONEL revenue?
    Generic penetration typically drives faster revenue compression than unit volume because pricing and rebates reset contract economics.

  4. What drives real-world continuation for ACTONEL patients?
    Persistence is driven by tolerability of oral dosing, patient adherence to dosing instructions, and comorbidity patterns common in older osteoporosis cohorts.

  5. What types of product strategies can extend lifecycle value for ACTONEL?
    Strategies tend to focus on access (payer contracting), adherence/persistence programs, and any differentiated formulation or IP that can defend a non-bulk price position.


References

  1. [No sources were provided in the prompt, and no external clinical or market databases were supplied for citation.]

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.