CLINICAL TRIALS PROFILE FOR ATELVIA

All Clinical Trials for ATELVIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03861091 ↗	Prophylactic Riserodrenate for Patients With Peripheral Lung Tumors Treated With SBRT	Recruiting	National Cancer Institute (NCI)	Phase 2	2019-07-12	This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
NCT03861091 ↗	Prophylactic Riserodrenate for Patients With Peripheral Lung Tumors Treated With SBRT	Recruiting	Wake Forest University Health Sciences	Phase 2	2019-07-12	This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
NCT04922333 ↗	Bisphosphonate Use to Mitigate Bone Loss	Not yet recruiting	Wake Forest University Health Sciences	Phase 3	2022-07-01	The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).

Clinical Trial Conditions for ATELVIA

Condition Name

Condition Name for ATELVIA
Intervention	Trials
Bone Loss	1
Lung Neoplasm	1
Lung Tumor	1

Condition MeSH

Condition MeSH for ATELVIA
Intervention	Trials
Bone Diseases, Metabolic	1
Lung Neoplasms	1

Clinical Trial Locations for ATELVIA

Trials by Country

Trials by Country for ATELVIA
Location	Trials
United States	2

Trials by US State

Trials by US State for ATELVIA
Location	Trials
North Carolina	2

Clinical Trial Progress for ATELVIA

Clinical Trial Phase

Clinical Trial Phase for ATELVIA
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ATELVIA
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for ATELVIA

Sponsor Name

Sponsor Name for ATELVIA
Sponsor	Trials
Wake Forest University Health Sciences	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for ATELVIA
Sponsor	Trials
Other	2
NIH	1

Last updated: August 1, 2026

Atelvia (risedronate delayed-release tablets) remains a legacy, off-patent brand in the US. Market upside depends on label breadth, payer treatment guidelines, and conversion to generics, with clinical-trial activity limited to small studies, postmarketing investigations, and potential combination or dosing studies rather than new registrational programs.

Atelvia clinical trials update, market size, and forecast (risedronate delayed-release)

What clinical trials are happening for Atelvia (risedronate delayed-release tablets)?

Direct registrational pipeline signals: No public evidence of active, late-stage (Phase 3) registrational trials that would materially change Atelvia’s US regulatory status or expand indications. Atelvia’s commercial posture is consistent with a mature, legacy bisphosphonate product where trial activity concentrates on formulary/real-world outcomes, adherence, gastroesophageal tolerability, and comparative effectiveness.

Where “Atelvia” trials typically show up in registries

• Adherence and persistence studies: delayed-release dosing schedules and tolerability can drive persistence differences versus immediate-release or other osteoporosis agents.
• Switching studies: transitions between risedronate formulations or between bisphosphonate classes.
• Special populations: GI tolerability, renal function subgroups (as permitted by labeling), and elderly adherence.
• Safety follow-ups: osteonecrosis of the jaw, atypical femur fracture risk monitoring is usually postmarketing and observational.

How large is the Atelvia market and what drives demand?

Atelvia targets postmenopausal osteoporosis and glucocorticoid-induced osteoporosis prevention/treatment depending on the approved label and local guideline adoption. Demand drivers are standard for oral osteoporosis therapy:

• Guideline penetration for bisphosphonates in first-line or early-line therapy.
• Payer restrictions and step edits (cost and formulary placement).
• Switching dynamics between bisphosphonates and higher-potency agents (other oral agents, injectable antiresorptives).
• Adherence: once-daily and regimen simplicity affect persistence more than new mechanism claims, since the mechanism is shared across many generics.

Commercially, Atelvia functions as:

• A brand price anchor within risedronate delayed-release until generic substitution.
• A tolerability and convenience option relative to alternative dosing rules.

What is the Orange Book status of Atelvia (risedronate delayed-release)?

Atelvia is a legacy product; the relevant regulatory exclusivity and patent estate structure for a delayed-release risedronate brand is typically dominated by:

• Expired composition-of-matter and core method patents.
• Residual formulation, dosage regimen, or manufacturing method patents that can delay certain generic entry in narrow scenarios.
• Labeling and exclusivity that may influence switching and timing.

Practical implication for market forecasting: generic availability and substitution dynamics usually dominate the forecast after early exclusivity windows close.

When does Atelvia lose exclusivity and what are the generic entry risks?

Generic entry risk is high and ongoing for mature bisphosphonates when:

• Core patents have expired or are close to expiration.
• Multiple ANDA pathways have been used to secure substitution.
• Bioequivalence requirements are readily met for tablet formulations.

Modeling impact: forecasts should assume continued erosion from generic substitution unless there is a persistent late-surviving patent barrier or a persistent formulary advantage.

How does Atelvia compare with other osteoporosis drugs (alendronate, ibandronate, zoledronic acid, denosumab)?

Atelvia is a bisphosphonate. Competitive positioning is mostly around:

• Oral convenience and GI tolerability versus immediate-release alternatives.
• Persistence compared with agents that require clinic administration (zoledronic acid) or injection schedules (denosumab).
• Insurance design: many payers prefer lowest net cost oral agents, pushing branded Atelvia toward premium compression.

Competitive substitution hierarchy in practice

• If generics are available for equivalent oral bisphosphonates, Atelvia tends to lose share to lower WAC and contracted pricing.
• If payers emphasize adherence metrics or specific tolerability, delayed-release formulations can retain a niche.

What patent estate and litigation affects Atelvia generics?

For legacy bisphosphonates with long market history, litigation typically follows the ANDA pattern:

• Paragraph IV challenges to brand patents.
• Settlement agreements that can include launch delays or non-infringement findings.

Market impact: where settlements exist, they set the timing for generic launches. Once generic entry occurs, Atelvia’s revenue declines rapidly due to substitution and contracting behavior.

What formulations are protected for risedronate delayed-release and how does that affect generic switching?

Generic switching depends on whether the generic must replicate:

• Delayed-release performance targets (dissolution profiles, pH-dependent release behavior).
• Tablet architecture (coating, excipient system) to match bioequivalence criteria.
• Stability and manufacturing method constraints when residual patents exist.

Practical forecast mechanism: even if some patents remain, generic entry often proceeds once a generic can design around or obtain non-infringement positions.

What FDA regulatory status does Atelvia have (approval pathway and label situation)?

Atelvia is an approved NDA product. The regulatory question for forecasting is not pathway approval but:

• Current label indications and any recent label updates.
• Any new REMS, postmarketing requirements, or safety communications that could shift demand.

For mature oral osteoporosis agents, demand shocks usually come from:

• Safety communications that change prescribing behavior.
• Insurance formulary changes.
• Availability or supply disruptions.

What is the commercial forecast for Atelvia (base case, downside, upside)?

Base case (most consistent with a legacy brand):

• Continued share loss from generic risedronate delayed-release or broader osteoporosis formulary substitution.
• Revenue decline at a rate determined by payer contracts and persistence among patients intolerant to alternative regimens.

Downside case:

• Accelerated net price compression due to increased generic competition.
• Higher switching triggered by payer step-edit enforcement.
• Safety-driven prescribing declines across the class that reduce total bisphosphonate prescriptions.

Upside case:

• Persistent formulary placement via contracting that preserves a premium over generic immediate-release options.
• Demonstrated real-world adherence advantage that payers accept in outcomes-based or value frameworks.
• Any new clinical evidence that supports more conservative use of alternatives, keeping delayed-release risedronate in the “preferred oral” bucket.

Clinical trial update: what should be monitored for the next 12-36 months?

Given the mature nature of Atelvia:

• Registry activity with “risedronate delayed-release” tags, especially adherence/persistence endpoints.
• Observational comparative studies (claims-based) comparing persistence and discontinuation.
• Safety surveillance updates that alter risk communication.
• Formulation-focused bioequivalence filings and approvals that indicate further generic competitive pressure.

Market projection assumptions (how to build a 3-year model)

Use these inputs for scenario modeling:

1. Share loss curve: tie to generic approvals and substitution in oral osteoporosis.
2. Net price path: incorporate contracting and rebate pressure typical after generic entry.
3. Total category growth/decline: osteoporosis treatment volumes, guideline-driven demand, and patient persistence.
4. Switching between oral and injectable agents: injectable uptick can reduce oral bisphosphonate share independent of generic substitution.
5. Adherence-driven retention: delayed-release products can retain a smaller segment even after generic availability.

A model aligned with legacy brands typically shows:

• Rapid post-entry erosion within 12-24 months.
• Slower decline thereafter as the market stabilizes around generic-led pricing.

Key competitive landscape dynamics

• Generic densification: more ANDAs and multiple generic SKUs increase the likelihood of aggressive contracting.
• Class competition: denosumab and certain other agents can expand within cohorts that need robust potency or clinic-supported dosing, shifting mix away from oral bisphosphonates.
• Patient tolerability: delayed-release formulations can retain patients who discontinue immediate-release due to GI symptoms.

Key Takeaways

• Atelvia is a legacy bisphosphonate brand; clinical-trial activity relevant to demand is likely limited to smaller, non-registrational studies and real-world outcomes.
• Forecasts should assume ongoing generic substitution and net price pressure; the main uncertainty is the speed and depth of contract-driven share erosion.
• Market upside is most plausible via payer-recognized adherence and tolerability advantages rather than new regulatory expansion.
• Next 12-36 months should be monitored via registry activity and generic entry approvals that signal further competitive intensity.

FAQs

1. Are there any ongoing Phase 3 trials for Atelvia (risedronate delayed-release)?
2. Does Atelvia have different safety outcomes versus other oral bisphosphonates?
3. How does delayed-release risedronate compare with immediate-release risedronate in real-world persistence?
4. What is the most likely generic launch path for risedronate delayed-release tablet products?
5. Which payer factors most influence Atelvia retention versus switching to cheaper osteoporosis generics?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. Search results for “risedronate delayed-release” and “Atelvia.” U.S. National Library of Medicine.