Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR CAVERJECT


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All Clinical Trials for CAVERJECT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00544076 ↗ ED Recovery in Men Age Terminated City of Hope Medical Center Phase 3 2006-01-01 RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction. PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.
NCT06768177 ↗ Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE) ENROLLING_BY_INVITATION Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari NA 2023-04-01 Patients are randomized into 2 groups (A and B), subsequently group A is subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP while group B is subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg. After 4 (four) weeks the groups will be crossed, so group A will be subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg while group B will be subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CAVERJECT

Condition Name

Condition Name for CAVERJECT
Intervention Trials
Erectile Dysfunctions 1
Male Erectile Disorder 1
Prostate Cancer 1
Stage I Prostate Cancer 1
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Condition MeSH

Condition MeSH for CAVERJECT
Intervention Trials
Erectile Dysfunction 2
Prostatic Neoplasms 1
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Clinical Trial Locations for CAVERJECT

Trials by Country

Trials by Country for CAVERJECT
Location Trials
Italy 1
United States 1
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Trials by US State

Trials by US State for CAVERJECT
Location Trials
California 1
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Clinical Trial Progress for CAVERJECT

Clinical Trial Phase

Clinical Trial Phase for CAVERJECT
Clinical Trial Phase Trials
Phase 3 1
NA 1
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Clinical Trial Status

Clinical Trial Status for CAVERJECT
Clinical Trial Phase Trials
Terminated 1
ENROLLING_BY_INVITATION 1
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Clinical Trial Sponsors for CAVERJECT

Sponsor Name

Sponsor Name for CAVERJECT
Sponsor Trials
City of Hope Medical Center 1
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari 1
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Sponsor Type

Sponsor Type for CAVERJECT
Sponsor Trials
Other 2
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CAVERJECT (alprostadil) — Clinical Trials Update, Market Analysis, and Projection

Last updated: May 2, 2026

What is CAVERJECT and how is it positioned in current care?

CAVERJECT is alprostadil, a prostaglandin E1 analog, used for erectile dysfunction (ED) via intracavernosal injection (marketed formulations differ by country and product line). Commercially, the brand sits in a well-established ED market where treatment choice depends on patient preference, injection tolerance, contraindications, and response to phosphodiesterase-5 (PDE5) inhibitors.

In the branded pipeline sense, CAVERJECT’s commercial lifecycle is mature: the core active ingredient is longstanding, and current “trial activity” is usually characterized by new studies aimed at optimizing use, delivery formats, durability of effect, and comparative endpoints rather than brand-new mechanism differentiation.

What clinical trial activity exists and what does it indicate?

A complete, up-to-date “clinical trials update” that supports market timing and competitive positioning requires a live registry pull and product-specific study mapping (phase, endpoints, recruiting status, primary completion dates). This information is not present in the provided materials, so a complete and accurate trials update cannot be produced.

Why no trial-by-trial update is provided here

No citations, registry links, or study identifiers (NCT numbers, EudraCT numbers, sponsor and status dates) are available in the prompt content. Without those, producing a trial-by-trial narrative would risk factual error (trial status drift is common across ED studies, and many alprostadil studies are not branded to CAVERJECT).

How big is the CAVERJECT addressable market and what drives demand?

Even without a live trial feed, ED market structure can be analyzed at the level of drivers that affect alprostadil injection demand:

Key demand drivers

  • Patients who do not respond to or cannot use PDE5 inhibitors: intracavernosal therapy is common after inadequate PDE5 response.
  • Long-term tolerability and clinician familiarity: entrenched dosing protocols and physician experience sustain baseline use.
  • Formulation access and reimbursement: injectable therapies are sensitive to payer coverage policies, prior authorization requirements, and pharmacy distribution.

Key constraints

  • Competition from alternative second-line ED therapies: intraurethral alprostadil and vacuum erection devices compete on route and convenience.
  • Safety and user burden: injection training, risk management (fibrosis risk, priapism protocols), and adherence.
  • Patent and exclusivity posture: older active ingredients often face extensive generics/biosimilar-like substitution depending on jurisdictional protections and formulation differentiation.

What does the competitive landscape look like for alprostadil intracavernosal ED therapy?

CAVERJECT’s practical competitive set in ED includes:

  • Other alprostadil brands or equivalents (formulation and dosing device differences can matter for adoption).
  • Non-prostaglandin injection therapies used in ED in some markets (mechanism differs by jurisdiction and product availability).
  • Device-based ED care (vacuum erection devices) and systemic options (PDE5 inhibitors, combination therapy).

For business decisions, the relevant question is not “who exists,” but whether CAVERJECT has a durability advantage (clinical outcomes, ease of use, dosing range, patient preference), or whether it suffers from substitution (price erosion, payer switching, physician protocol changes).

Market projection framework for CAVERJECT

Without live clinical-trial status and without jurisdiction-specific commercial datapoints (sales by geography, pricing history, payer coverage changes), any numeric projection would be speculative. A projection that is decision-grade typically requires at least:

  • historical CAVERJECT net sales or prescription volumes,
  • share trend versus comparators,
  • pricing and reimbursement trajectory,
  • expected patent/exclusivity events and generic entry dates by market.

Those inputs are not provided, so no numeric forecast is issued.

Decision-grade projection logic (qualitative, still actionable)

CAVERJECT demand in the medium term is typically shaped by four forces:

  1. Substitution risk

    • If payer formularies favor lower-cost alternatives, CAVERJECT volumes compress even when overall second-line ED treatment demand holds.
  2. Clinical practice stability

    • ED second-line injection protocols tend to persist once established, which can stabilize baseline use.
  3. Access and training

    • Initiation of intracavernosal therapy depends on clinic readiness, patient training capacity, and follow-up monitoring.
  4. Safety perception management

    • Education on priapism prevention and fibrosis monitoring influences continuation rates.

What commercialization signals should investors and R&D leaders track next for CAVERJECT?

Even without a numeric projection, these are the measurable indicators that usually predict volume changes in mature ED injection brands:

  • Formulary status changes: tier placement, PA requirements, step therapy adoption
  • Pricing actions: wholesale acquisition cost changes, net price erosion, rebate intensity shifts
  • Volume indicators: prescriptions, claims counts, and prescriber distribution
  • Switch events: substitution from CAVERJECT to other alprostadil products or alternative mechanisms
  • Product supply reliability: stock-outs and manufacturing constraints that can cause lasting prescriber behavior changes

Key Takeaways

  • CAVERJECT is a mature ED intracavernosal alprostadil product positioned as second-line therapy for patients who fail PDE5 inhibitors or cannot use them.
  • A complete, accurate clinical trials update cannot be produced from the information provided, because no study identifiers or live registry data are included.
  • Numeric market projections cannot be issued without historical sales/prescription and market-access inputs.
  • Decision-grade monitoring should focus on formulary and reimbursement, pricing/net revenue erosion, substitution dynamics, and claims-based volume trends.

FAQs

1) Is CAVERJECT still used widely for erectile dysfunction?

Yes. It remains used as a second-line option where PDE5 inhibitors are inadequate or unsuitable, but its share is shaped by payer coverage and substitution to alternative therapies.

2) Do clinical trials typically change the standard of care for alprostadil injections?

Most activity in mature ED injectables targets optimization (dosing, technique, patient outcomes). Practice change usually tracks stronger comparative or outcome data plus payer uptake, not labeling alone.

3) What most strongly affects CAVERJECT demand?

Reimbursement coverage, relative price versus alternatives, and prescriber protocol habits in second-line ED management.

4) What are the main competitive threats to CAVERJECT?

Lower-cost alprostadil alternatives, other second-line ED therapies, and device-based options that can capture patients seeking fewer injection steps.

5) What signals should trigger a market forecast refresh for CAVERJECT?

Formulary tier changes, net pricing shifts, new generic or alternative entry events in key geographies, and sustained claim-volume inflections versus ED therapy comparators.


References

[1] None.

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