CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M HSA

505(b)(2) Clinical Trials for Technetium Tc 99m Hsa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for Technetium Tc 99m Hsa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001003 ↗	A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors (breathing pattern, pulmonary function) that may be important in affecting the actual dose delivered to a given patient. The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.
NCT00001277 ↗	Studies of Elevated Parathyroid Activity	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)		1993-12-15	Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperthyroidism and to evaluate and improve methods for diagnosis and treatment. In this study, patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions such as parathyroid tumors, will also be selected. Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing. Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body.
NCT00003654 ↗	Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer	Terminated	UNICANCER	N/A	1997-09-01	RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors. PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.
NCT00004705 ↗	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis	Completed	University of North Carolina	N/A	1996-09-01	OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.
NCT00004705 ↗	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis	Completed	FDA Office of Orphan Products Development	N/A	1996-09-01	OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.

Clinical Trial Conditions for Technetium Tc 99m Hsa

Condition Name

Condition Name for Technetium Tc 99m Hsa
Intervention	Trials
Breast Cancer	16
Prostate Cancer	4
Melanoma	4
Healthy	4

Condition MeSH

Condition MeSH for Technetium Tc 99m Hsa
Intervention	Trials
Breast Neoplasms	23
Carcinoma	13
Prostatic Neoplasms	13
Neoplasms	7

Clinical Trial Locations for Technetium Tc 99m Hsa

Trials by Country

Trials by Country for Technetium Tc 99m Hsa
Location	Trials
United States	225
Canada	26
United Kingdom	15
China	14
Italy	9

Trials by US State

Trials by US State for Technetium Tc 99m Hsa
Location	Trials
California	17
Texas	15
Washington	13
Pennsylvania	12
New York	12

Clinical Trial Progress for Technetium Tc 99m Hsa

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc 99m Hsa
Clinical Trial Phase	Trials
PHASE2	8
PHASE1	4
Phase 4	7

Clinical Trial Status

Clinical Trial Status for Technetium Tc 99m Hsa
Clinical Trial Phase	Trials
Completed	69
Recruiting	25
Terminated	15

Clinical Trial Sponsors for Technetium Tc 99m Hsa

Sponsor Name

Sponsor Name for Technetium Tc 99m Hsa
Sponsor	Trials
National Cancer Institute (NCI)	20
Endocyte	9
Tomsk National Research Medical Center of the Russian Academy of Sciences	8

Sponsor Type

Sponsor Type for Technetium Tc 99m Hsa
Sponsor	Trials
Other	144
Industry	69
NIH	33

Technetium Tc 99m HSA Clinical Trials Update, Market Analysis, and Forecast: Pipeline Status, Exclusivity, and Commercial Outlook

Last updated: May 26, 2026

Technetium Tc 99m HSA (human serum albumin, Tc-99m labeled) is a radiopharmaceutical used for imaging blood pool/perfusion depending on the protocol. Market and clinical development are dominated by (1) supply constraints and manufacturing qualification rather than late-stage efficacy differentiation, and (2) regulatory lifecycle events for the specific branded kit and its generics/substitutes. Public clinical-trial activity is limited and fragmented across sponsors and geographies, so practical “pipeline” visibility is largely determined by FDA approval history for kits, label changes, and post-approval manufacturing/quality actions rather than new pivotal trials.

What is Technetium Tc 99m HSA and what indications drive demand?

Technetium Tc 99m HSA refers to Tc-99m–labeled human serum albumin, typically supplied as a kit reconstituted with technetium Tc-99m. The product is used in nuclear medicine for blood pool imaging and related diagnostic workflows, with exact indication language controlled by the approved label of the specific brand.

How is Tc-99m HSA used in practice?

Common real-world uses include:

• Blood pool imaging (cardiac blood pool studies in nuclear cardiology workflows)
• Imaging protocols where a Tc-99m albumin tracer provides favorable biodistribution for the requested diagnostic question

Which stakeholders buy and influence utilization?

Demand is driven by:

• Nuclear medicine departments at hospitals and imaging centers
• Radiopharmacy networks that qualify generators/kits and manage inventory
• Group purchasing organizations and payer coverage policies that indirectly shape utilization volume

What are the latest clinical trials updates for Technetium Tc 99m HSA?

A current, complete clinical-trials “update” requires a sponsor-level view of active interventional trials and ongoing studies registered on ClinicalTrials.gov (or equivalent registries). Under the constraint of producing a complete and accurate response without missing data, this topic cannot be fully delivered from the information provided in the request.

What is the current market size for Technetium Tc 99m HSA?

A credible market-size estimate for Tc-99m HSA depends on:

• Kit-level unit consumption (vials/kits per year)
• Average selling price by geography and channel
• Competition from alternative radiotracers used for similar clinical questions
• Tender and contract dynamics in radiopharmacy supply chains

With only the drug name supplied and no market dataset referenced, a complete and accurate market-size figure cannot be produced.

How do you forecast demand for Technetium Tc 99m HSA through 2030?

Forecasting Tc-99m HSA is more supply-chain and regulatory lifecycle dependent than therapeutic-class growth driven. A workable forecast framework in this category is usually built from:

• Procedure-volume growth in nuclear medicine imaging
• Replacement of aging supply sources and qualification of alternate manufacturers
• Replacement cycles for radiopharmacy inventory and kit availability
• Impacts from radionuclide supply, logistics, and manufacturing capacity

A numerical projection requires baseline consumption and pricing inputs that are not provided.

Which FDA-approved Technetium Tc 99m HSA products exist, and what is their exclusivity status?

This analysis requires:

• The specific FDA product names (brand kits) for Tc-99m HSA
• Orange Book listing details (active ingredient, dosage form, strength)
• Listed patents and expiration dates by NDA or ANDA, plus any pediatric exclusivity or market exclusivity references
• Whether the product is an NDA or an ANDA and the status of any listed patents

The request does not provide the branded product name(s), NDA/ANDA identifiers, or Orange Book entry data, so a complete exclusivity and expiration timeline cannot be generated.

What patents protect Technetium Tc 99m HSA and how many are there per product?

Patent estate mapping requires:

• Identifying the Orange Book listings for each Tc-99m HSA kit NDA/ANDA
• Capturing each listed patent number, claims type (composition, formulation, method of use, manufacturing, delivery)
• Listing expiration dates and any terminal disclaimers

Without the Orange Book record(s) for the specific products, this cannot be done accurately.

When does Technetium Tc 99m HSA lose exclusivity, and what generic entry risks exist?

Generic entry risk for radiopharmaceutical kits depends on:

• Patent expiration and any continuing listed patents that remain before “effective” generic readiness
• Citizen petitions and patent litigation that affect approval timelines
• Whether competitors can file an abbreviated pathway or whether reliance on reference formulation is constrained

A correct exclusivity loss date and Para. IV risk assessment require specific FDA product IDs and patent listings.

What patent litigation affects Technetium Tc 99m HSA?

Patent litigation outcomes materially change near-term market access, but they must be sourced from:

• Docket entries (e.g., USPTO/ED/CA cases)
• Settlement agreements and consent judgments
• Court decisions affecting listed patents or product-specific claims

No litigation case list or product identifier was provided; a complete litigation-status update cannot be generated.

How does Technetium Tc 99m HSA compare with alternative radiotracers for blood pool imaging?

Competitive displacement is primarily about:

• Image quality and protocol compatibility with gamma cameras
• Biodistribution and patient handling workflow
• Availability and cost per study
• Label restrictions and reimbursement alignment

A defensible comparison requires knowing the competitors used in the same clinical workflow in the relevant geographies (for example, alternative blood pool tracers) and their FDA-approved indications, which are not provided.

What delivery systems or formulations are protected for Tc-99m HSA?

Radiopharmaceutical “formulation” protection can include:

• Composition claims covering the kit ingredients
• Methods for radiolabeling (labeling conditions, pH windows, stannous reducing agent amounts)
• Sterile manufacturing and lyophilized kit specifications
• Stabilizers and excipient systems that affect shelf life

This requires product-specific patent and Orange Book claim-type extraction that cannot be completed from the prompt.

Commercial projection scenarios for Technetium Tc 99m HSA: base, bull, bear

A scenario model in this category typically varies:

• Volume growth tied to nuclear cardiology and imaging utilization
• Price dynamics from competition (entry timing, tender wins)
• Manufacturing supply stability and spend on alternative sourcing

A numerical scenario table needs:

• Baseline revenue and unit volumes
• Region split
• Competitor set and expected entry dates

Those inputs are missing.

Key market drivers and constraints for Technetium Tc 99m HSA

Market drivers

• Sustained demand for nuclear medicine imaging workflows using albumin tracers
• Stable clinical utility in standard protocols

Constraints

• Radiopharmaceutical supply chain sensitivity (manufacturing capacity qualification)
• Regulatory and patent “kit lifecycle” barriers
• Pricing pressure when substitutes are available

Key Takeaways

• A product name-only request is insufficient to generate a complete, accurate clinical-trial update, market-size figure, exclusivity timeline, patent estate map, or litigation status for Technetium Tc 99m HSA.
• In Tc-99m radiopharmaceuticals, commercial outcomes track more closely to kit-level regulatory status, supply availability, and patent/Orange Book lifecycle than to high-visibility late-stage clinical development.

FAQs

1. Is Technetium Tc 99m HSA undergoing new pivotal trials?
2. How do patent expirations for radiopharmaceutical kits affect generic entry timing?
3. What manufacturing or radiolabeling process changes can trigger regulatory action for Tc-99m HSA kits?
4. Do hospital radiopharmacies switch from Tc-99m HSA to alternative blood pool tracers based on reimbursement or image quality?
5. What factors most influence Tc-99m radiopharmaceutical pricing and procurement contracts?

References

1. ClinicalTrials.gov. (n.d.). Search results for “Technetium Tc 99m HSA.”
2. FDA Orange Book. (n.d.). Drug Products with Therapeutic Equivalence Evaluations for Tc-99m HSA kit products.
3. U.S. Food and Drug Administration. (n.d.). Radiopharmaceutical drug product labeling and approval history resources.