CLINICAL TRIALS PROFILE FOR TALAZOPARIB TOSYLATE

All Clinical Trials for TALAZOPARIB TOSYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02282345 ↗	Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer	Active, not recruiting	Medivation, Inc.	Phase 2	2015-04-16	This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset (BRCA) gene. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may be especially effective in patients with BRCA mutations. It is not yet known whether adding talazoparib before standard treatment is safe in treating patients with BRCA mutated breast cancer.
NCT02282345 ↗	Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2015-04-16	This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset (BRCA) gene. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may be especially effective in patients with BRCA mutations. It is not yet known whether adding talazoparib before standard treatment is safe in treating patients with BRCA mutated breast cancer.
NCT02282345 ↗	Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer	Active, not recruiting	M.D. Anderson Cancer Center	Phase 2	2015-04-16	This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset (BRCA) gene. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may be especially effective in patients with BRCA mutations. It is not yet known whether adding talazoparib before standard treatment is safe in treating patients with BRCA mutated breast cancer.
NCT02286687 ↗	Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes	Recruiting	BioMarin Pharmaceutical	Phase 2	2014-12-22	This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.
NCT02286687 ↗	Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes	Recruiting	National Cancer Institute (NCI)	Phase 2	2014-12-22	This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.
NCT02286687 ↗	Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes	Recruiting	M.D. Anderson Cancer Center	Phase 2	2014-12-22	This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.

Clinical Trial Conditions for TALAZOPARIB TOSYLATE

Condition Name

Condition Name for TALAZOPARIB TOSYLATE
Intervention	Trials
Breast Cancer	2
Advanced Breast Cancer	2
Advanced Malignant Solid Neoplasm	2
HER2/Neu Negative	2

Condition MeSH

Condition MeSH for TALAZOPARIB TOSYLATE
Intervention	Trials
Breast Neoplasms	3
Adenocarcinoma	2
Neoplasms	2
Carcinoma, Non-Small-Cell Lung	1

Clinical Trial Locations for TALAZOPARIB TOSYLATE

Trials by Country

Trials by Country for TALAZOPARIB TOSYLATE
Location	Trials
United States	49

Trials by US State

Trials by US State for TALAZOPARIB TOSYLATE
Location	Trials
Texas	5
California	3
New York	3
Montana	1
Missouri	1

Clinical Trial Progress for TALAZOPARIB TOSYLATE

Clinical Trial Phase

Clinical Trial Phase for TALAZOPARIB TOSYLATE
Clinical Trial Phase	Trials
Phase 2	6
Phase 1/Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for TALAZOPARIB TOSYLATE
Clinical Trial Phase	Trials
Recruiting	5
Active, not recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for TALAZOPARIB TOSYLATE

Sponsor Name

Sponsor Name for TALAZOPARIB TOSYLATE
Sponsor	Trials
National Cancer Institute (NCI)	7
M.D. Anderson Cancer Center	5
Pfizer	4

Sponsor Type

Sponsor Type for TALAZOPARIB TOSYLATE
Sponsor	Trials
Other	10
Industry	8
NIH	7

Talazoparib Tosylate: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is talazoparib tosylate and how is it positioned commercially?

Talazoparib tosylate is an oral PARP inhibitor used in oncology, with commercial footprint concentrated in BRCA-mutated breast cancer indications and expanding into additional solid-tumor settings where PARP inhibition is clinically supported. Uptake is shaped by label coverage, payer positioning versus competing PARP inhibitors, and the speed at which new-line and combination use-cases expand.

From a market-structure standpoint, talazoparib competes in a mature PARP inhibitor class where differentiation comes from dosing practicality, evidence depth in BRCA-driven disease, and clinical trial programs that support expansion into broader biomarker and combination-defined populations.

Where do the talazoparib clinical trials stand now?

Active development for talazoparib is tracked through interventional studies across monotherapy and combination regimens, typically anchored in PARP-pathway biology (BRCA1/2 and homologous recombination deficiency) and expanded cohorts in advanced solid tumors.

Program activity snapshot (trial focus areas)

The current clinical trial ecosystem for talazoparib is concentrated in four recurring categories:

• Combination oncology: PARP inhibitor plus checkpoint inhibitor or targeted therapy
• Biomarker-defined expansion: BRCA-mutated and HRD-enriched cohorts
• Line-of-therapy expansion: post-chemotherapy and later-line settings, plus earlier-line feasibility
• Comparative or translational endpoints: response rate, duration of response, and mechanism-based translational markers

Clinical endpoint patterns that drive label expansion

Across PARP inhibitor development programs, the regulatory path depends on:

• Objective response rate (ORR) and duration of response (DoR) in single-arm settings
• Progression-free survival (PFS) in randomized or controlled comparisons
• Overall survival (OS) where feasible, often post-progression in later lines
• Safety and tolerability in combination regimens where hematologic toxicity drives dose management

Practical implications for near-term clinical readouts

For investment and R&D planning, talazoparib trials tend to generate value when:

• Safety holds up in combination arms that otherwise show hematologic signal risk
• Enrollment includes biomarker strata with strong prior response probability
• Follow-up duration supports durable effect claims (DoR and time-to-event)

(No trial-by-trial update set is provided here because an accurate “clinical trials update” requires a current list of active and recently reported studies, including dates, statuses, and results. Without that, a complete, accurate update cannot be produced.)

What does the market look like for PARP inhibitors, and where does talazoparib fit?

The PARP inhibitor market is characterized by:

• Dense competition across drugs with overlapping biomarker indications
• Payer pressure based on incremental benefit versus class peers
• Rapid line expansion as trial evidence matures
• Strong demand in BRCA-mutated and HRD-enriched oncology subsets

Competitive set (class peers)

Talazoparib’s most direct competitive pressure comes from other PARP inhibitors used in similar clinical contexts, including:

• Olaparib
• Niraparib
• Rucaparib
• (And other regionally marketed PARP options depending on geography)

Differentiation levers that matter for talazoparib

Talazoparib’s market performance is typically driven by:

• Label coverage: strength of indications and line-of-therapy positioning
• Clinical evidence density: quality and consistency of response and durability data
• Safety profile management: dose modification behavior in real-world practice
• Combination strategy: ability to support broader regimens without prohibitive toxicity

How should investors and operators project talazoparib revenues over the next 3 to 5 years?

A credible projection must be grounded in three variables:

1. Diagnosis and treatment penetration in covered indications
2. Share-of-prescription within PARP inhibitors under payer and guideline influence
3. Incremental indication capture from clinical evidence releases and label expansions

Because talazoparib-specific, current commercialization numbers (sales by geography, prescription counts, and net pricing) are not supplied here, a numeric revenue forecast cannot be produced without risking inaccuracy.

What can be projected reliably without site-specific sales inputs

The directional outlook for talazoparib is linked to:

• PARP class expansion into earlier lines and combination regimens (when tolerability supports it)
• Biomarker testing throughput that increases the addressable population for BRCA/HRD-driven therapies
• Competitive switching based on formulary placement and clinical preference

Scenario framework for planning (non-numeric)

For business planning, use a scenario ladder:

• Base case: steady penetration in core BRCA-mutated settings with gradual incremental gains from combination adoption
• Upside case: successful trial readouts that translate into additional label breadth and improved payer coverage
• Downside case: competitive displacement where peers capture more favorable guideline positioning or combination tolerability limits constrain uptake

(A numeric projection is omitted because it requires current talazoparib sales, unit volumes, price/mix, and geography-specific payer conditions, none of which are provided in the prompt.)

What are the key risks and what drives upside for talazoparib?

Key risks

• Class competition: formulary pressure from other PARP inhibitors
• Safety/tolerability in combinations: hematologic toxicity drives dose reductions and discontinuations
• Biomarker complexity: HRD testing availability and interpretation vary by market
• Clinical bar for incremental benefit: marginal PFS/OS improvements can fail to shift payer behavior

Upside drivers

• Demonstrated durability: sustained DoR and time-to-event improvements in new settings
• Combination success: improved tolerability profiles enable broader adoption
• Guideline incorporation: rapid translation of trial results into practice patterns
• Payer alignment: favorable net pricing and prior authorization criteria within target geographies

Market watchlist: what should be monitored next for talazoparib?

• Regulatory updates: new label expansions, supplementary approvals, and changes to dosing recommendations
• Guideline publication cycles: NCCN/ESMO updates (or local equivalents) that shift sequencing to PARP inhibitors
• Trial readouts: combination efficacy plus safety endpoints that influence clinician adoption
• Real-world utilization signals: prescription trends and persistence in the core indications

Key Takeaways

• Talazoparib is a PARP inhibitor whose commercial trajectory depends on label strength in BRCA/HRD-driven disease, combination adoption, and payer behavior within a highly competitive PARP class.
• A complete “clinical trials update” with dates, trial statuses, and results cannot be produced here without a current, specific trial set.
• A numeric 3- to 5-year revenue projection cannot be issued without talazoparib-specific current sales, pricing, and unit data.
• Operational planning should follow a scenario ladder tied to label expansion probability, combination tolerability outcomes, and guideline-driven sequencing.

FAQs

1. Is talazoparib used as monotherapy or in combinations?
   It is used both as monotherapy and in combination regimens in ongoing clinical development, with adoption shaped by evidence strength and tolerability.

2. What determines how fast talazoparib gains share in PARP-treated patients?
   Label coverage by line of therapy, payer formulary status, guideline uptake, and evidence that supports meaningful durable benefit.

3. What safety factor most affects PARP inhibitor uptake?
   Hematologic toxicity and the clinical feasibility of dose modifications in monotherapy and especially combinations.

4. What biomarkers are central to PARP inhibitor selection for talazoparib?
   BRCA1/2 mutation and HRD status, with additional stratification increasingly used in solid-tumor expansion trials.

5. What would most improve talazoparib’s market position next?
   Trial readouts that lead to label expansion and create payer-friendly adoption pathways in earlier lines or newly supported combination settings.

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References

[1] FDA. “Talzenna (talazoparib) Prescribing Information.” U.S. Food and Drug Administration. https://www.accessdata.fda.gov/ (accessed 2026-04-24).
[2] EMA. “Talzenna: Summary of Product Characteristics (SmPC).” European Medicines Agency. https://www.ema.europa.eu/ (accessed 2026-04-24).
[3] National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer and Ovarian/Fallopian Tube Cancer (updates for PARP inhibitors). https://www.nccn.org/ (accessed 2026-04-24).