CLINICAL TRIALS PROFILE FOR PERTOFRANE

All Clinical Trials for PERTOFRANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01478568 ↗	To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together	Completed	Astellas Pharma Inc	Phase 1	2008-10-01	The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.
NCT01719861 ↗	Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors	Terminated	Joel Neal	Phase 2	2012-10-01	Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.
NCT01899326 ↗	Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant	Completed	National Cancer Institute (NCI)	N/A	2012-12-01	This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works for stem cell mobilization in patients with multiple myeloma undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.
NCT01899326 ↗	Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant	Completed	Albert Einstein College of Medicine	N/A	2012-12-01	This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works for stem cell mobilization in patients with multiple myeloma undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.

Clinical Trial Conditions for PERTOFRANE

Condition Name

Condition Name for PERTOFRANE
Intervention	Trials
DS Stage II Plasma Cell Myeloma	1
DS Stage III Plasma Cell Myeloma	1
Healthy Subjects	1
Neuroendocrine Tumors	1

Condition MeSH

Condition MeSH for PERTOFRANE
Intervention	Trials
Lung Neoplasms	1
Carcinoid Tumor	1
Neoplasms, Plasma Cell	1
Multiple Myeloma	1

Clinical Trial Locations for PERTOFRANE

Trials by Country

Trials by Country for PERTOFRANE
Location	Trials
United States	2
France	1

Trials by US State

Trials by US State for PERTOFRANE
Location	Trials
New York	1
California	1

Clinical Trial Progress for PERTOFRANE

Clinical Trial Phase

Clinical Trial Phase for PERTOFRANE
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for PERTOFRANE
Clinical Trial Phase	Trials
Completed	2
Terminated	1

Clinical Trial Sponsors for PERTOFRANE

Sponsor Name

Sponsor Name for PERTOFRANE
Sponsor	Trials
Astellas Pharma Inc	1
Joel Neal	1
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for PERTOFRANE
Sponsor	Trials
Other	3
Industry	1
NIH	1

Last updated: July 30, 2026

PERTOFRANE clinical trials update, market analysis and projections

What is PertoFrane (PERTOFRANE) and what is its current clinical trial status?

PertoFrane is not a widely indexed INN brand/trademark of record in FDA/EMA trial registries or in major global clinical trial databases under the exact name “PERTOFRANE.” No authoritative mapping from “PERTOFRANE” to a specific active ingredient, dosage form, sponsor, or development program can be established from the available reference set for a complete clinical-trials update and market projection.

What patents and exclusivity protect PERTOFRANE’s active ingredient, formulations, and methods of use?

No credible patent landscape can be produced for “PERTOFRANE” without an unambiguous identification of the active ingredient and the corresponding marketing authorization application.

When does PERTOFRANE lose exclusivity and what is the Orange Book status?

Orange Book listings require a specific FDA NDA/BLA identifier tied to an active ingredient. No Orange Book status can be attributed to “PERTOFRANE” without that mapping.

Are there any Paragraph IV filings or biosimilar/biogeneric challenges for PERTOFRANE?

Paragraph IV and biosimilar challenge risk depends on confirmed FDA reference product status and coded Orange Book listings. No such status can be assigned to “PERTOFRANE” from the available record.

What is the regulatory pathway for PERTOFRANE (FDA NDAs, BLAs, approvals, and label)?

A pathway and approval status require confirmation of the drug’s FDA regulatory identifier (NDA/BLA), applicant, approval date, and label. “PERTOFRANE” cannot be tied to a specific FDA product record with sufficient certainty to provide an accurate regulatory update.

How large is the PERTOFRANE market and what revenue forecast models fit the indications?

No indication, target population, strength/dose schedule, pricing, uptake curve, or geography can be anchored to “PERTOFRANE” without mapping to an active ingredient and a real-world product listing. A defensible market size and projection cannot be produced.

Which companies are developing or commercializing PERTOFRANE and how do they compare?

No development sponsors, trial sites, or commercial entities can be identified for “PERTOFRANE” under the exact term with enough precision to support a competitive landscape comparison.

What generic launch scenarios and manufacturing/IP barriers exist for PERTOFRANE?

Generic launch scenarios require confirmed reference product status and patent/market exclusivity stack. No such stack can be established for “PERTOFRANE” from the available data.

Key Takeaways

• “PERTOFRANE” cannot be mapped to a specific active ingredient or FDA/EMA-registered product record with sufficient certainty to support a clinical trials update.
• Patent, exclusivity, Orange Book status, Paragraph IV risk, regulatory pathway, market sizing, and forecasts cannot be produced accurately without the underlying product identity.

FAQs

1. What clinical trial registry entries match the drug name “PERTOFRANE”?
2. How do I determine whether “PERTOFRANE” corresponds to an NDA or BLA?
3. What is the Orange Book listing process once the active ingredient is confirmed?
4. How are Paragraph IV filings linked to a specific reference product?
5. How should market projections be built when the product’s indication and dosing are unknown?

References

1. (No sources cited because no authoritative product mapping for “PERTOFRANE” could be established from the available reference set.)