Name: LB-102 in Schizophrenia: Access and distribution
Published: 2026-10-08T10:27:28-04:00

Current access through clinical trials only

“Currently, participation in one of our clinical trials is the only way to access our investigational products.” (opens the source at this quote in a new tab)
“We encourage patients interested in our investigational products to learn more about our ongoing studies by visiting www.clinicaltrials.gov.” (opens the source at this quote in a new tab)

Expanded access policy

“Consistent with our commitment to bringing safe and effective therapies to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our investigational products available to patients as quickly and safely as possible.” (opens the source at this quote in a new tab)
“Treating physicians may request information about our Expanded Access policy by contacting clinicaltrials@lbpharma.us. LB Pharmaceuticals will respond to inquiries within 5 business days of receipt.” (opens the source at this quote in a new tab)

Continued access for NOVA-2 completers through the open-label trial

“Patients who complete NOVA-2 will be able to continue in the Open Label Extension trial that will also enroll de novo patients.” (opens the source at this quote in a new tab)

Commercial preparation

“While we have hired a Chief Commercial Officer to lead the development of our commercial strategy, we do not currently have a commercial organization for the marketing, sales, market access and distribution of prescription pharmaceutical products.” (opens the source at this quote in a new tab)
“We expect to manage future sales, marketing, market access and distribution through internal resources and third-party relationships.” (opens the source at this quote in a new tab)

“As we approach our pivotal NOVA-2 clinical trial results and continue preparing for the potential launch of LB-102 in schizophrenia, Joe’s extensive experience guiding companies from pivotal data through commercialization will be a tremendous asset.” (opens the source at this quote in a new tab)

Manufacturing and supply

“We do not own or operate, and currently have no plans to establish, any manufacturing facilities.” (opens the source at this quote in a new tab)
“Additionally, we intend to rely on third-party CDMOs for later-stage development and commercial manufacturing, if our product candidates receive marketing approval.” (opens the source at this quote in a new tab)
“Key starting material is manufactured by a limited number of CDMOs. The final drug substance is manufactured at a single CDMO.” (opens the source at this quote in a new tab)
“To adequately meet our projected commercial manufacturing needs, our CDMOs will need to scale-up production, or we will need to secure additional suppliers.” (opens the source at this quote in a new tab)

Planned commercial territories and partnering

“We currently own global rights to LB-102 and intend to retain commercialization rights in the United States.” (opens the source at this quote in a new tab)
“In addition, we will opportunistically explore commercialization partnerships, particularly with entities that have strong capabilities in geographies outside of the United States.” (opens the source at this quote in a new tab)

Distribution channel, specialty pharmacy requirement, and risk evaluation and mitigation strategy

No evidence found.