CLINICAL TRIALS PROFILE FOR LITHONATE

All Clinical Trials for LITHONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	National Cancer Institute (NCI)	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	Fred Hutchinson Cancer Research Center	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00870311 ↗	Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients	Completed	National Institute of Mental Health (NIMH)	Phase 4	1996-03-01	This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.
NCT00870311 ↗	Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients	Completed	Wayne State University	Phase 4	1996-03-01	This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.
NCT01820624 ↗	Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	Completed	National Cancer Institute (NCI)	Phase 1	2013-04-30	This phase I trial studies the side effects and best dose of tretinoin when given together with lithium carbonate in treating patients with relapsed or refractory acute myeloid leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tretinoin may help [type of cancer] cells become more like normal cells, and to grow and spread more slowly. Giving lithium carbonate together with tretinoin may kill more cancer cells
NCT01820624 ↗	Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	Completed	Paolo Caimi, MD	Phase 1	2013-04-30	This phase I trial studies the side effects and best dose of tretinoin when given together with lithium carbonate in treating patients with relapsed or refractory acute myeloid leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tretinoin may help [type of cancer] cells become more like normal cells, and to grow and spread more slowly. Giving lithium carbonate together with tretinoin may kill more cancer cells

Clinical Trial Conditions for LITHONATE

Condition Name

Condition Name for LITHONATE
Intervention	Trials
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)	2
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	2
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities	2
Recurrent Adult Acute Myeloid Leukemia	2

Condition MeSH

Condition MeSH for LITHONATE
Intervention	Trials
Leukemia, Myelomonocytic, Acute	2
Leukemia, Myeloid, Acute	2
Leukemia	2
Leukemia, Myeloid	2

Clinical Trial Locations for LITHONATE

Trials by Country

Trials by Country for LITHONATE
Location	Trials
United States	3

Trials by US State

Trials by US State for LITHONATE
Location	Trials
Ohio	1
Michigan	1
Washington	1

Clinical Trial Progress for LITHONATE

Clinical Trial Phase

Clinical Trial Phase for LITHONATE
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LITHONATE
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for LITHONATE

Sponsor Name

Sponsor Name for LITHONATE
Sponsor	Trials
National Cancer Institute (NCI)	2
Fred Hutchinson Cancer Research Center	1
National Institute of Mental Health (NIMH)	1

Sponsor Type

Sponsor Type for LITHONATE
Sponsor	Trials
Other	3
NIH	3

Last updated: May 30, 2026

LITHONATE clinical trials update and market forecast: Which indications, trial status, and launch economics matter most?

What is LITHONATE and what active ingredient or formulation defines the product?

No sufficient product identity details (active ingredient, strength, dosage form, sponsor, or FDA regulatory reference) are available to produce a complete and accurate clinical-trials update and market projection for “LITHONATE.”

What clinical trials exist for LITHONATE, and what is the latest status by phase?

No sufficient, source-backed information is available to list LITHONATE trials by phase, enrollment, sites, endpoints, or readouts.

Which indications are LITHONATE targeting in Phase 1, 2, or 3 trials?

No indication-level trial mapping can be produced from the available information.

What are the most recent trial readouts and timelines (last updated date, next expected milestones)?

No readout dates or timeline milestones can be validated for LITHONATE.

Are there safety or efficacy signals that changed development decisions?

No validated safety/efficacy signals are available for LITHONATE.

When will LITHONATE submit to FDA (NDA/BLA) and what is the projected first commercial launch window?

No regulatory pathway, filing status, or submission timeline can be established from the available information.

What FDA pathway is LITHONATE on (505(b)(2), 505(j), 351(a), 351(k), fast track, breakthrough, orphan)?

No pathway or exclusivity drivers can be determined.

What does the FDA review timeline imply for launch timing?

No submission or review data is available.

How big is the market for LITHONATE and what is the revenue projection under base, upside, and downside cases?

No sufficient information is available to define the addressable indication, comparable therapies, pricing assumptions, or payer access hurdles needed to project revenue.

What is the TAM/SAM/SOM framework for LITHONATE by geography and payer segment?

No claimable geography, eligible patient counts, or payer coverage parameters are available.

What price and uptake assumptions drive the model for LITHONATE?

No dosing regimen, label assumptions, or competitor adoption curves are available.

How does LITHONATE compare with current standard of care and pipeline competitors?

No comparable products or active competitors can be identified from the available information.

Which companies are developing LITHONATE and what licensing or partnering activity affects value?

No sponsor identity, trial ownership, or licensing/partnership disclosures are available to support market and pipeline valuation.

What are the key commercial risks for LITHONATE (manufacturing, supply constraints, reimbursement, and switching)?

No product-specific manufacturing strategy, supply chain readiness, reimbursement positioning, or switching/therapeutic class dynamics are available.

What IP risks exist for LITHONATE (Orange Book, patents, exclusivity) and how do they impact generics or biosimilars?

No IP record can be produced because LITHONATE’s active ingredient and FDA-listed reference product are not identified in the available information.

Key Takeaways

• LITHONATE’s product identity (active ingredient, dosage form, and FDA/clinical program context) is not specified in the available information, preventing a source-backed clinical trials update and market forecast.
• No validated trial phase status, readouts, regulatory milestones, competitor landscape, or pricing and revenue assumptions can be established.

FAQs

1. What is the active ingredient and dosage form for LITHONATE, and which regulatory submission does it map to?
2. Which LITHONATE clinical trials are recruiting versus completed, and what are the primary endpoints?
3. What regulatory pathway and expected FDA decision timeline applies to LITHONATE?
4. What are the main competitor therapies and how does LITHONATE differentiate in efficacy, safety, and cost?
5. What IP coverage exists for LITHONATE (patents and exclusivity) and what is the generic entry risk timeline?