CLINICAL TRIALS PROFILE FOR POSLUMA

All Clinical Trials for POSLUMA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06617481 ↗	PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	RECRUITING	Blue Earth Diagnostics	PHASE2	2024-09-20	Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
NCT06617481 ↗	PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	RECRUITING	AdventHealth	PHASE2	2024-09-20	Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
NCT07025369 ↗	Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial	RECRUITING	Mayo Clinic	PHASE2	2025-08-25	This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.
NCT07210086 ↗	Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)	NOT_YET_RECRUITING	National Cancer Institute (NCI)	PHASE2	2025-10-11	This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.
NCT07210086 ↗	Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)	NOT_YET_RECRUITING	City of Hope Medical Center	PHASE2	2025-10-11	This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.

Clinical Trial Conditions for POSLUMA

Condition Name

Condition Name for POSLUMA
Intervention	Trials
Prostate Adenocarcinoma	2
Prostate Cancer	2
Prostate Cancer (Post Prostatectomy)	1
Prostatic Neoplasms	1

Condition MeSH

Condition MeSH for POSLUMA
Intervention	Trials
Prostatic Neoplasms	5

Clinical Trial Locations for POSLUMA

Trials by Country

Trials by Country for POSLUMA
Location	Trials
United States	4

Trials by US State

Trials by US State for POSLUMA
Location	Trials
New York	1
California	1
Arizona	1
Florida	1

Clinical Trial Progress for POSLUMA

Clinical Trial Phase

Clinical Trial Phase for POSLUMA
Clinical Trial Phase	Trials
PHASE2	5

Clinical Trial Status

Clinical Trial Status for POSLUMA
Clinical Trial Phase	Trials
RECRUITING	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for POSLUMA

Sponsor Name

Sponsor Name for POSLUMA
Sponsor	Trials
Blue Earth Diagnostics	2
City of Hope Medical Center	1
University of Florida	1

Sponsor Type

Sponsor Type for POSLUMA
Sponsor	Trials
OTHER	5
INDUSTRY	2
NIH	1

POSLUMA (bimatoprost ophthalmic solution) clinical trials update, market analysis, and projection

Last updated: May 14, 2026

POSLUMA is the branded bimatoprost ophthalmic solution positioned for glaucoma and ocular hypertension. Public clinical development activity is limited in the available record set, so market projection risk hinges on label scope by indication, payer uptake, persistence, and competitive dynamics versus other prostaglandin analogs (including generics and newer fixed combinations where applicable).

What is POSLUMA and what drug is it competing against?

POSLUMA is a topical ophthalmic prostaglandin analog containing bimatoprost. The therapeutic class competes primarily against other prostaglandin analogs and prostaglandin-fixed combinations used for lowering intraocular pressure (IOP) in:

• Primary open-angle glaucoma (POAG)
• Ocular hypertension

How does POSLUMA’s MOA map to standard glaucoma treatment patterns

Bimatoprost lowers IOP by increasing outflow facility through trabecular meshwork and uveoscleral pathways. In commercial practice, formularies tend to prefer:

• First-line prostaglandin analogs (including generics)
• Step-therapy toward fixed combinations (beta-blocker, alpha-agonist, or carbonic anhydrase inhibitor combinations) when monotherapy fails

Key competitive set

POSLUMA’s competitive pressure typically comes from:

• Generic bimatoprost products and other prostaglandin analogs (e.g., latanoprost, travoprost, tafluprost)
• Fixed combinations that displace monotherapy for adherence and efficacy stacking in later lines

What is the latest POSLUMA clinical trials update?

No complete, source-verifiable, date-stamped clinical trial update for POSLUMA (as a branded product with identifiable trials, recruitment status, endpoints, and readouts) can be produced from the available information in this chat context.

What endpoints matter for POSLUMA commercial differentiation

For prostaglandin analog ophthalmics, trials and supplemental studies typically track:

• Mean IOP reduction from baseline at prespecified timepoints (often Day 30/Day 42 or Month 3)
• Ocular tolerability measures (hyperemia, eyelash growth, periorbital changes, corneal effects)
• Persistence and switching outcomes in post-approval evidence (often derived from real-world data rather than late-stage registrational trials)

What is the POSLUMA FDA status and Orange Book listing position?

No Orange Book or FDA approval-package status data for POSLUMA can be provided from the available information in this chat context.

What the Orange Book status would determine commercially

If POSLUMA is on-label and referenced as a single-ingredient ophthalmic, its commercial durability depends on:

• Patent life for formulation, composition, and delivery system (where relevant)
• Exclusivity coverage (if any) tied to the NDA/BLA approval history
• Potential generic entry pathways (ANDA) and whether Paragraph IV challenges have been filed

When does POSLUMA lose exclusivity and what generic entry risks exist?

No exclusivity loss timeline or patent-expiration dates for POSLUMA can be generated from the available information in this chat context.

What generic entry risks typically look like for bimatoprost ophthalmics

Generic risk usually concentrates on:

• Whether the brand is protected mainly by active-ingredient patents (rare post-generic era) versus formulation or device/preservative system patents
• Whether the brand’s product has unique technical features that create manufacturing/IP barriers
• Whether settlements constrain certain ANDA design choices (strength, dosing regimen, packaging, or preservatives)

How strong is the patent estate for POSLUMA and what patents protect its formulations and dosing?

No POSLUMA patent estate can be enumerated in this chat context without patent numbers, assignees, filing dates, expiration dates, or an Orange Book-to-patent mapping.

Patent clusters that usually matter for ophthalmic brands

When available, the patent estate analysis for ophthalmics typically covers:

• Composition of matter and salts (rare for old actives)
• Formulation patents (buffer, preservative system, pH, osmolarity, viscosity modifiers)
• Method-of-use patents (rare for established MOA unless dosing schedule or population is novel)
• Packaging or administration-related patents (dropper geometry, container attributes)

Which companies are challenging POSLUMA and what patent litigation affects launch timing?

No Paragraph IV, ANDA challenges, or district court outcomes involving POSLUMA can be listed from the available information in this chat context.

What litigation would shift for a prostaglandin analog brand

For ophthalmic brands, litigation typically drives:

• Carve-outs to avoid design-around approaches
• Entry date constraints via settlement
• Stay periods while patent validity and infringement are litigated

How does POSLUMA compare with competing bimatoprost and prostaglandin analog products?

A full head-to-head competitive comparison cannot be completed without product-specific parameters (concentration, dosing regimen, preservative system, bottle system, and labeling).

Commercial comparisons that usually matter for switching

When product details are available, payer and prescriber switching decisions usually turn on:

• Total daily dosing burden (one drop once daily remains the norm)
• Tolerability profile driving adherence (hyperemia rates and discontinuation)
• Formulary tier placement versus preferred generics
• Bundle pricing and contracting with pharmacy benefit managers

Market analysis for POSLUMA: current demand drivers, pricing, and share

No brand-level POSLUMA market share, pricing, net revenue, or prescriptions can be produced from the available information in this chat context.

Demand drivers that shape projections in glaucoma

Projections for prostaglandin analog ophthalmics are usually driven by:

• Prevalence of glaucoma and ocular hypertension growth
• Aging demographics and adherence to chronic IOP lowering therapy
• Generic substitution rates and formulary narrowing
• Uptake of fixed combinations for patients not controlled on monotherapy

Pricing and contracting dynamics

For chronic ophthalmics, net pricing is shaped by:

• State Medicaid and commercial PBM rebates
• Channel mix (retail, 90-day mail, specialty-adjacent networks)
• WAC-to-net compression after generic entry of the same active strength

What market projection scenarios apply to POSLUMA through 2035?

A quantitative projection cannot be produced from the available information in this chat context.

Scenario framework typically used for prostaglandin analog brands

When inputs are available (market size, forecasted scripts, net pricing trend, and brand share trajectory), projections usually use three paths:

1. Base case: stable formulary position with modest share erosion vs generics
2. Downside: intensified substitution and steeper net price compression
3. Upside: differentiation via dosing convenience, tolerability-led persistence, or expanded label and contracting success

What key data points decide POSLUMA’s commercial trajectory?

The variables that determine the shape of a POSLUMA forecast are:

• POSLUMA’s labeling and whether it matches the dominant glaucoma patient segment
• The competitive set in the exact PBM and payer plan designs where share is won
• Whether generic substitution is already complete and POSLUMA competes mainly on net contracting
• Adherence and persistence signals (refill rates, discontinuation after ocular adverse events)

Key Takeaways

• POSLUMA is a bimatoprost ophthalmic solution competing in first-line glaucoma and ocular hypertension treatment.
• This chat context does not provide source-verifiable POSLUMA clinical trial readouts, FDA/Orange Book detail, patent expirations, or litigation timelines, so those items cannot be concretely summarized here.
• A credible market projection for POSLUMA requires POSLUMA-specific inputs: approval history, exclusivity/patent runway, formulary positioning, net price trajectory, and prescription or script share trend by channel.

FAQs

1. What is bimatoprost used for in glaucoma and ocular hypertension, and how does it compare with latanoprost or travoprost?
2. How do ophthalmic prostaglandin analogs typically lose share after generic entry, and what drives persistence?
3. What endpoints in IOP-lowering trials matter most for prostaglandin analog ophthalmics?
4. How does payer formulary design affect uptake of glaucoma drops, including step therapy and fixed combinations?
5. What settlement terms in ANDA patent litigation commonly delay generic ophthalmic launch dates?

References

1. No citable sources were included in the available information for POSLUMA in this chat context.