Last Updated: June 25, 2026

CLINICAL TRIALS PROFILE FOR BINOSTO


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for BINOSTO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02781805 ↗ Pilot Study of Bisphosphonates for Breast Cancer Terminated National Cancer Institute (NCI) Phase 1 2016-08-05 The goal of this study is to mechanistically define the potential anticancer activities of the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP "window trial" to examine the effect of 1 - 3 weeks administration of alendronate on women at high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell differentiation.
NCT02781805 ↗ Pilot Study of Bisphosphonates for Breast Cancer Terminated Wisconsin Partnership Program Phase 1 2016-08-05 The goal of this study is to mechanistically define the potential anticancer activities of the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP "window trial" to examine the effect of 1 - 3 weeks administration of alendronate on women at high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell differentiation.
NCT02781805 ↗ Pilot Study of Bisphosphonates for Breast Cancer Terminated University of Wisconsin, Madison Phase 1 2016-08-05 The goal of this study is to mechanistically define the potential anticancer activities of the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP "window trial" to examine the effect of 1 - 3 weeks administration of alendronate on women at high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell differentiation.
NCT04403698 ↗ The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover Recruiting Amgen Phase 2 2019-11-13 It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect), after discontinuation of denosumab treatment in a non-osteoporotic population.
NCT04403698 ↗ The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover Recruiting EffRx Pharmaceuticals Phase 2 2019-11-13 It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect), after discontinuation of denosumab treatment in a non-osteoporotic population.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BINOSTO

Condition Name

Condition Name for BINOSTO
Intervention Trials
Ischemic Necrosis 1
Osteonecrosis 1
Sickle Cell Anemia 1
Sickle Cell Disease 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for BINOSTO
Intervention Trials
Anemia, Sickle Cell 1
Osteoarthritis 1
Breast Neoplasms 1
Osteonecrosis 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for BINOSTO

Trials by Country

Trials by Country for BINOSTO
Location Trials
Belgium 1
United States 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for BINOSTO
Location Trials
Wisconsin 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for BINOSTO

Clinical Trial Phase

Clinical Trial Phase for BINOSTO
Clinical Trial Phase Trials
Phase 2 2
Phase 1 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 BINOSTO
Clinical Trial Phase Trials
Recruiting 1
Terminated 1
Not yet recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for BINOSTO

Sponsor Name

Sponsor Name for BINOSTO
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 1
University of California, Davis 1
National Cancer Institute (NCI) 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for BINOSTO
Sponsor Trials
Other 6
NIH 2
Industry 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

BINOSTO (alendronic acid effervescent): Clinical Trials Update, Market Analysis, and 10-Year Projection

Last updated: April 29, 2026

What is BINOSTO and how is it positioned in the bisphosphonate market?

BINOSTO is an oral alendronate (bisphosphonate) in an effervescent formulation. It targets standard indications for alendronate use, including postmenopausal osteoporosis and, in various markets, related bone disorders. Its differentiation in practice is formulation convenience versus conventional tablets, aimed at patients who have difficulty swallowing tablets and those where effervescence improves adherence.

BINOSTO’s key commercial structure

  • Drug class: Bisphosphonate (alendronate)
  • Form: Effervescent oral
  • Core positioning: Tablet-to-effervescent switch to improve usability and adherence in osteoporosis care pathways
  • Therapeutic category: Osteoporosis / fracture prevention standard of care in multiple geographies

What clinical-trial activity exists for BINOSTO specifically?

No complete, audit-ready set of BINOSTO-specific interventional clinical trials with current-stage disclosures is available in the provided material. A BINOSTO-specific clinical-trial update must rely on recordable trial registries and sponsor disclosures; without those inputs, only non-specific general alendronate evidence can be stated, which would not meet “BINOSTO-specific” accuracy.

Therefore, this report does not publish a BINOSTO-specific clinical trials update timeline (phase-by-phase recruitment status, endpoints, and results) because it would require traceable trial records not contained in the input.

What is driving BINOSTO’s demand in osteoporosis care?

BINOSTO competes inside a mature osteoporosis treatment market with constrained innovation. Demand drivers are mainly adherence, persistence, tolerability, and cost, not clinical breakthroughs.

Market pull factors that favor an effervescent option

  • Adherence friction reduction: Oral bisphosphonates have strict administration rules; formulation that patients perceive as easier to take can improve persistence.
  • Patient tolerability: Effervescent administration can change the patient experience versus tablet ingestion.
  • Provider prescribing behavior: In mature markets, once a formulation has an established label and distribution channel, uptake depends on switching volume from existing alendronate products.

Headwinds

  • Class-level competitive pressure: Generic alendronate products concentrate pricing.
  • Low differentiation on outcomes: Efficacy is class-consistent; outcomes are typically supported by alendronate evidence rather than BINOSTO-specific novel endpoints.
  • Competing alternatives: Denosumab, teriparatide/abaloparatide, and romosozumab take share in parts of high-risk populations when reimbursement supports them.

How does BINOSTO benchmark against key comparators?

Benchmarks in the bisphosphonate category tend to cluster around:

  1. Generic alendronate tablets (lowest price, wide availability)
  2. Alternative oral bisphosphonates (risedronate, ibandronate in some markets)
  3. Injectables (denosumab and others) in high-risk subgroups

BINOSTO’s practical competitive axis is switching/persistence, not efficacy differentiation.

Market analysis: where BINOSTO fits and how share is likely allocated

A defensible market analysis requires geography-specific sales and payer dynamics, plus BINOSTO’s regulatory footprint (which markets it is marketed in), pack strength, and pricing history. Those elements are not included in the input set.

Given the constraints, the report limits “market analysis and projection” to a framework-based forecast that can be computed only when actual sales baselines and geographies are known. Since those are not provided, a numeric projection is not published.

What projections can be provided without a sales baseline?

None. A market projection for a drug requires at least one of:

  • historical revenue/units by geography,
  • audited market size by indication with BINOSTO share assumptions,
  • pricing and reimbursement trajectories.

Without those, projecting BINOSTO volume, revenue, and share would be non-actionable and not audit-grade.

Business-relevant scenario drivers for projections (non-numeric)

Even without numbers, the projection logic is stable and can be used by finance teams to structure underwriting once baseline sales are inserted:

1) Switch dynamics

  • Tablet-to-effervescent migration depends on patient pool willing to switch and physician willingness to prescribe based on administration preference.
  • Share gains are typically modest and cumulative, reflecting “convenience-driven persistence” rather than clinical superiority.

2) Competitive price pressure

  • Generic entry and price resets within alendronate categories compress revenue per unit.
  • Effervescent products usually carry higher cost per dose than generic tablets; payer support determines whether that premium persists.

3) Persistence and discontinuation

  • Osteoporosis persistence is variable. Any formulation that improves early persistence can lift long-term treated lives and revenue continuity even without expanding incident cases.

4) Indication mix shift

  • High-risk patients increasingly initiate on injectables when reimbursement supports it.
  • Effervescent bisphosphonates are strongest in populations staying within oral bisphosphonate pathways.

5) Patent and exclusivity timeline

  • For a mature active ingredient, exclusivity is formulation- and registration-dependent. If BINOSTO’s formulation IP is limited, branded premium revenue can erode post-competition.

Key takeaways

  • BINOSTO is an effervescent formulation of alendronate positioned for osteoporosis adherence and usability versus standard tablets.
  • A BINOSTO-specific clinical trials update cannot be produced accurately without recordable trial-stage evidence in the provided material.
  • A numeric market projection cannot be produced audit-grade without historical BINOSTO sales, geography coverage, and pricing/reimbursement inputs.
  • The projection model should be driven by switch-to-effervescent dynamics, alendronate price compression, persistence effects, indication mix shifts toward injectables, and any formulation-level exclusivity.

FAQs

1) Is BINOSTO clinically different from standard alendronate?

BINOSTO differentiates by formulation and administration experience. In osteoporosis care, outcomes are class-consistent; competitive advantage is typically adherence and persistence, not fundamentally different efficacy.

2) What phase of development is BINOSTO in?

BINOSTO is not a development-stage product in most markets; it is a marketed formulation. A phase-by-phase “current trials update” for BINOSTO specifically cannot be issued here without traceable trial records.

3) Who are BINOSTO’s main competitors?

Main competitors are other oral bisphosphonates and generic alendronate tablets, with injectables (notably denosumab and other high-risk options) taking additional share in some reimbursement environments.

4) What determines whether BINOSTO can sustain premium pricing?

Premium persistence depends on payer coverage and whether patient and prescriber switching translates into measurable persistence and reduced discontinuation versus tablet generics.

5) What is the highest-impact driver for long-term volume growth?

The highest-impact driver is treated-life persistence within oral osteoporosis pathways, which formulation can influence, rather than expansion of the total osteoporosis population alone.

References

[1] FDA. “Alendronate (and related bisphosphonate) prescribing information” (accessed via published label materials).
[2] EMA. “Product information and assessment materials for alendronate medicines” (accessed via European public assessment and product pages).
[3] GlobalData / EvaluatePharma style market compendia (if BINOSTO sales are queried in institutional feeds, baseline needed).

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.